References for First-In-Class Biologics and Pharmacological Similar Biologics

Part 3: First-In-Class Biologics and Part 4: Pharmacological Similar Biologics
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1. +
Morrison  C. Fresh from the biotech pipeline-2018. Nat Biotechnol. 2019;37(2):118–123.
[PubMed: 30718867] .
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2. +
Crysvita® (burosumab-twza) injection for subcutaneous use [product information]. Revised: 04/2018. Ultragenyx Pharmaceutical Inc.; Novato, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761068s000lbl.pdf (accessed Jan 1, 2019).
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3. +
GamifantTM (emapalumab-lzsg) injection for intravenous use [product information]. Revised: 11/2018. Sobi Inc.; Waltham, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761107s000lbl.pdf (accessed Jan. 1, 2019).
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4. +
AimovigTM (erenumab-aooe) injection for subcutaneous use [product information]. Revised: 5/2018. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf (accessed Jan. 1, 2019).
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5. +
AjovyTM (fremanezumab-vfrm) injection for subcutaneous use [product information]. Revised: 9/2018. Teva Pharmaceuticals USA, Inc.; North Wales, PA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761089s000lbl.pdf (accessed Jan. 1, 2019).
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6. +
Emgality (galcanezumab-gnlm) injection for subcutaneous use [product information]. Revised: 9/2018. Eli Lilly and Company; Indianapolis, IN. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf (accessed Jan. 1, 2019).
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7. +
TrogarzoTM (ibalizumab-uiyk) injection for intravenous use [product information]. Revised: 05/2018. Theratechnologies Inc.; Montréal, Québec Canada. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065s001lbl.pdf (accessed Mar. 2, 2019).
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8. +
TakhzyroTM (lanadelumab-flyo) injection for subcutaneous use [product information]. Revised: 11/2018. Dyax Corp.; Lexington, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s001lbl.pdf (accessed Jan. 1, 2019).
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9. +
Poteligeo® (mogamulizumab-kpkc) injection for intravenous use [product information]. Revised: 08/2018. Kyowa Kirin, Inc.; Bedminster Township, NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf (accessed Jan. 1, 2019).
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10. +
OxervateTM (cenegermin-bkbj) solution for topical ophthalmic use [product information]. Revised: 8/2018. Dompé U.S. Inc.; Boston, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761094s000lbl.pdf (accessed Mar. 2, 2019).
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11. +
Andexxa® (coagulation factor Xa (recombinant), inactivated-zhzo) lyophilized powder for solution and Intravenous Injection [product information]. Revised: 2018. Portola Pharmaceuticals, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM606687.pdf (accessed Mar. 2, 2019).
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12. +
Palynziq (pegvaliase-pqpz) injection for subcutaneous use [product information]. Revised: 5/2018. BioMarin Pharmaceutical Inc.; Novato, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf (accessed Mar. 2, 2019).
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13. +
Elzonris (tagraxofusp-erzs) injection for intravenous use [product information]. Revised: 12/2018. Stemline Therapeutics, Inc.; New York, NY. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761116s000lbl.pdf (accessed Mar. 2, 2019).
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14. +
FDA-Approved Biosimilar Products [webpage]. Last Updated: 12/14/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580432.htm (accessed Jan. 1, 2019).
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15. +
Biosimilar and Interchangeable Products [webpage]. Last Updated: 10/23/2017. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm (accessed Feb. 19, 2018).
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16. +
Center for Drug Evaluation and Research List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date [webpage]. Last Updated: 2/6/2019. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf (accessed Feb. 22, 2019).
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17. +
LumoxitiTM (moxetumomab pasudotox-tdfk) injection for intravenous use [product information]. Revised: 9/2018. AstraZeneca Pharmaceuticals LP; Wilmington, DE. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf (accessed Jan. 1, 2019).
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18. +
Libtayo® (cemiplimab-rwlc) injection for intravenous use [product information]. Revised: 09/2018. Regeneron Pharmaceuticals, Inc.; Tarrytown, NY. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf (accessed Jan. 1, 2019).
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19. +
UltomirisTM (ravulizumab-cwvz) injection for intravenous use [product information]. Revised: 12/2018. Alexion Pharm; Boston, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761108s000lbl.pdf (accessed Jan. 1, 2019).
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20. +
IlumyaTM (tildrakizumab-asmn) injection for subcutaneous use [product information]. Revised: 03/2018. Merck Sharp & Dohme Corp.; Whitehouse Station, NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf (accessed Jan. 1, 2019).
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21. +
Biological License Application Approvals [webpage]. Last Updated: 01/31/2019. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm596371.htm (accessed Mar. 2, 2019).
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22. +
AsparlasTM (calaspargase pegol-mknl) injection, for intravenous use [product information]. Revised: 12/2018. Servier Pharmaceuticals LLC. Boston, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.pdf (accessed Mar. 2, 2019).
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23. +
Revcovi (elapegademase-lvlr) injection for intramuscular use [product information]. Revised: 10/2018. Leadiant Biosciences, Inc.; Gaithersburg, MD). Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761092s000lbl.pdf (accessed Mar. 2, 2019).
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24. +
VaxelisTM (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) Suspension for Intramuscular Injection [product information]. Revised: 12/2018. Merck Sharp & Dohme Corp.; Whitehouse Station, NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/UCM629109.pdf (accessed Mar. 2, 2019).
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25. +
CY 2018 CDER Breakthrough Therapy Calendar Year Approvals: Data as of December 31, 2018 [webpage]. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugandbiologicapprovalreports/ndaandblaapprovalreports/ucm494010.pdf (accessed Feb. 21, 2019).
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26. +
Gardasil® (Human Papillomavirus 9-valent Vaccine, Recombinant) Suspension for Intramuscular injection [product information. Revised: 10/2018. Merck Sharp & Dohme Corp.; Whitehouse Station, NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf (accessed Mar. 2, 2019).
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27. +
Gardasil 9 [webpage]. Last Updated: 10/10/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm426445.htm (accessed Mar. 2, 2019).
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28. +
FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia [FDA News Release]. April 17, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604810.htm (accessed Jan. 1, 2019).
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29. +
Drug Trials Snapshot: CRYSVITA [webpage] Page Last Updated: 05/01/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm605956.htm (accessed Jan. 1, 2019).
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30. +
FDA approves first drug for neurotrophic keratitis, a rare eye disease [FDA News Release]. August 22, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm618047.htm (accessed Mar. 2, 2019).
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31. +
Drug Trials Snapshot: Gamifant [webpage]. Last Updated: 12/07/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm627806.htm (accessed Jan. 1, 2019).
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32. +
FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease [FDA News Release]. November 20, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626263.htm (accessed Jan. 1, 2019).
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33. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves emapalumab for hemophagocytic lymphohistiocytosis [webpage]. Last Updated: Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626280.htm (accessed Jan. 1, 2019).
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34. +
Drug Trials Snapshots: Aimovig [webpage]. Last Updated: 06/14/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm610434.htm (accessed Jan. 1, 2019).
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35. +
FDA approves novel preventive treatment for migraine [FDA News Release]. May 17, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm (accessed Jan. 1, 2019).
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36. +
Drug Trials Snapshot: Ajovy [webpage]. Last Updated: 10/15/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm623050.htm (accessed Jan. 1, 2019).
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37. +
FDA approves new HIV treatment for patients who have limited treatment options [FDA News Release]. March 6, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm (accessed Jan. 6, 2019).
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38. +
Drug Trials Snapshots: Trogarzo [webpage]. Last Updated: 03/20/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm601383.htm (accessed Jan. 1, 2019).
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39. +
FDA approves new treatment for rare hereditary disease [FDA News Release]. August 23, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/ucm618261.htm (accessed Jan. 1, 2019).
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40. +
Drug Trials Snapshots: Takhzyro [webpage]. Last Updated: 09/06/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm619361.htm (accessed Jan. 1, 2019).
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41. +
FDA approves treatment for two rare types of non-Hodgkin lymphoma [FDA News Release]. August 8, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616176.htm (accessed Jan. 1, 2019).
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42. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves mogamulizumab-kpkc for mycosis fungoides or Sézary syndrome [webpage]. Last Updated: 08/08/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm616180.htm (accessed Jan. 3, 2019).
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43. +
Drug Trials Snapshot: Poteligeo [webpage]. Last Updated: 08/22/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ucm617675.htm (accessed Jan. 1, 2019).
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44. +
FDA approves a new treatment for PKU, a rare and serious genetic disease [FDA News Release]. May 24, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608835.htm (accessed Jan. 1, 2019).
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45. +
Drug Trials Snapshot: Palynziq [webpage]. Last Updated: 06/21/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ucm611328.htm (accessed Jan. 1, 2019).
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46. +
FDA approves new treatment for adult patients with rare, life-threatening blood disease [FDA News Release]. December 21, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629022.htm (accessed Jan. 1, 2019).
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47. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm [webpage]. Last Updated: 12/21/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm629090.htm (accessed Jan. 3, 2019).
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American Headache Society. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache. 2019;59(1):1–18.
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Jo  M, Jung  ST. Engineering therapeutic antibodies targeting G-protein-coupled receptors. Exp Mol Med. 2016;48:e207.
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Diener  HC. CGRP antibodies for migraine prevention—new kids on the block. Nat Rev Neurol. 2019;15(3):129–130.
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Dolgin  E. First GPCR-directed antibody passes approval milestone. Nat Rev Drug Discov. 2018;17(7):457–459.
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Noonan  D. New Nerve Drugs May Finally Prevent Migraine Headaches. December 1, 2015. Available from: Scientific American. www.scientificamerican.com/article/new-nerve-drugs-may-finally-prevent-migraine-headaches/ (accessed Mar. 2, 2019).
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Edvinsson  L, Haanes  KA, Warfvinge  K,  et al. CGRP as the target of new migraine therapies—successful translation from bench to clinic. Nat Rev Neurol. 2018;14(6):338–350. Review.
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Majima  M, Ito  Y, Hosono  K,  et al. CGRP/CGRP Receptor antibodies: Potential adverse effects due to blockade of neovascularization? Trends Pharmacol Sci. 2019;40(1):11–21.
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Kee  Z, Kodji  X, Brain  SD. The role of calcitonin gene related peptide (CGRP) in neurogenic vasodilation and its cardioprotective effects. Front Physiol. 2018;9:1249.
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Bigal  ME, Rapoport  AM, Silberstein  SD,  et al. From LBR-101 to fremanezumab for migraine. CNS Drugs. 2018;32(11):1025–1037.
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Bohm  PE, Stancampiano  FF, Rozen  TD. Migraine headache: Updates and future developments. Mayo Clin Proc. 2018;93(11):1648–1653.
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Sparrow  AM, Searles  JW. The market for migraine drugs. Nat Rev Drug Disc. Available from: NatureResearch. http://www.nature.com/articles/d41573-018-00014-3 (accessed Mar. 2, 2019).
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Teva Announces U.S. Approval of AJOVYTM (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults [Press Release]. September 14, 2018. https://ir.tevapharm.com/investors/press-releases/press-release-details/2018/Teva-Announces-US-Approval-of-AJOVY-fremanezumab-vfrm-Injection-the-First-and-Only-Anti-CGRP-Treatment-with-Both-Quarterly-and-Monthly-Dosing-for-the-Preventive-Treatment-of-Mig (accessed Mar. 2, 2019).
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Dolgin  E. Migraine drug race turns its final corner, FDA decisions in sight. Nat Biotechnol. 2018;36(3):207–208.
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Babina  IS, Turner  NC. Advances and challenges in targeting FGFR signalling in cancer. Nat Rev Cancer. 2017;17(5):318–332.
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Vervloet  M. Renal and extrarenal effects of fibroblast growth factor 23. Nat Rev Nephrol. 2019;15(2):109–120.
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Kuro-O  M. The Klotho proteins in health and disease. Nat Rev Nephrol. 2019;15(1):27–44.
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Razzaque  MS. The FGF23-Klotho axis: endocrine regulation of phosphate homeostasis. Nat Rev Endocrinol. 2009;5(11):611–619.
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Highly specialised technologies guidance [HST8]: Burosumab for treating X-linked hypophosphataemia in children and young people. October 10, 2018. Available from: National Institute for Health Care Excellence (UK). www.nice.org.uk/guidance/hst8/chapter/7-Evaluation-committee-members-and-NICE-project-team (accessed Mar. 2, 2019).
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Genetics Home Reference: PHEX gene (phosphate regulating endopeptidase homolog X-linked) [webpage]. February 26, 2019. Available from: U.S. National Library of Medicine. https://ghr.nlm.nih.gov/gene/PHEX - synonyms (accessed Mar. 2, 2019).
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Committee for Medicinal Products for Human Use (CHMP) Assessment Report: Crysvita. December 14, 2017. EMA/148319/2018. Procedure No. EMEA/H/C/004275/0000. Available from: European Medicines Agency; London, England. http://www.ema.europa.eu/documents/assessment-report/crysvita-epar-public-assessment-report_en.pdf (accessed Mar. 2, 2019).
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Center for Drug Evaluation and Research. FDA MultiDisciplinary Review BLA 761068 (burosumab twza). Application Number: 761068Orig1s000. Digitally signed on January 17, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761068Orig1s000MultidisciplineR.pdf (accessed Mar. 2, 2019).
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Kinoshita  Y, Fukumoto  S. X-linked hypophosphatemia and FGF23-related hypophosphatemic diseases: Prospect for new treatment. Endocr Rev. 2018;39(3):274–291.
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Minisola  S, Peacock  M, Fukumoto  S,  et al. Tumour-induced osteomalacia. Nat Rev Dis Primers. 2017;3:17044.
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Versura  P, Giannaccare  G, Pellegrini  M,  et al. Neurotrophic keratitis: Current challenges and future prospects. Eye Brain. 2018;10:37–45.
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Committee for Medicinal Products for Human Use (CHMP) Assessment report: Oxervate. May 18, 2017. EMA/351805/2017. Procedure No. EMEA/H/C/004209/0000. Available from: European Medicines Agency; London, England. www.ema.europa.eu/documents/assessment-report/oxervate-epar-public-assessment-report_en.pdf (accessed Mar. 2, 2019).
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ClinicalTrials.gov. Identifier NCT03085290, Allogeneic Versus Autologous Serum Eye Drops (AVAnS). Available from: U.S. National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT03085290 (accessed Mar. 2, 2019).
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Clinical Guidelines: Serum Eye Drops for the Treatment of Severe Ocular Surface Disease. September 2017. Available from: The Royal College of Ophthalmologists. www.rcophth.ac.uk/wp-content/uploads/2017/11/Serum-Eye-Drops-Guideline.pdf (accessed Feb. 14, 2019).
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Technology appraisal guidance [TA532]: Cenegermin for treating neurotrophic keratitis. Published: July 18, 2018. Available from: National Institute for Health Care Excellence (UK). http://www.nice.org.uk/guidance/ta532 (accessed Mar. 2, 2019).
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Sacchetti  M, Bruscolini  A, Lambiase  A. Cenegermin for the treatment of neurotrophic keratitis. Drugs Today (Barc). 2017;53(11):585–595.
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Denby  A. London Medicines Evaluation Network Review: A summary of new antidotes to New Oral Anticoagulants (NOAC’s) and antidotes to NOAC’s currently in development, which could impact NOAC use in the future (Version Number: 1). February 2016. Available from: National Health Service Specialist Pharmacy Service (UK). http://www.sps.nhs.uk/wp-content/uploads/2016/02/LMEN_NOAC_antidotes_FINAL_FEB_2016.pdf (accessed Mar. 2, 2019).
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Andexxa—an antidote for apixaban and rivaroxaban. Med Lett Drugs Ther. 2018;60(1549):99-101. Corrected and republished in: JAMA. 2018;320(4):399–400.
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Canna  SW, Behrens  EM. Making sense of the cytokine storm: a conceptual framework for understanding, diagnosing, and treating hemophagocytic syndromes. Pediatr Clin North Am. 2012;59(2):329–344.
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172. +
Herceptin® (trastuzumab) for injection for intravenous use [product information]. Revised: 11/2018. Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf (accessed Mar. 3, 2019).
+
173. +
Ricart  AD. Antibody-drug conjugates of calicheamicin derivative: gemtuzumab ozogamicin and inotuzumab ozogamicin. Clin Cancer Res. 2011;17(20):6417–6427.
[PubMed: 22003069] .
+
174. +
Besponsa (inotuzumab ozogamicin) injection for intravenous use [product information]. Revised: 08/2017. Wyeth Pharmaceuticals, Inc.; Philadelphia, PA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf (accessed Mar. 3, 2019).
+
175. +
Campath® (alemtuzumab) Injection for intravenous use [product information]. Revised: 11/2018. Genzyme Corporation; Cambridge, MA Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5167lbl.pdf (accessed Mar. 3, 2019).
+
176. +
Lemtrada® (alemtuzumab) injection for intravenous use [product information]. Revised: 01/2019. Genzyme Corporation; Cambridge, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf (accessed Mar. 3, 2019).
+
177. +
FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab) [webpage]. Last Updated: 12/07/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/ucm624247.htm (accessed Mar. 3, 2019).
+
178. +
Tecentriq® (atezolizumab) injection for intravenous use [product information]. Revised: 6/2018. Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s010lbl.pdf (accessed Mar. 3, 2019).
+
179. +
FDA approves atezolizumab with chemotherapy and bevacizumab for first-line treatment of metastatic non-squamous NSCLC [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm627874.htm (accessed Jan. 3, 2019).
+
180. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients [webpage]. Last Updated: 07/05/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm612484.htm (accessed Jan. 3, 2019).
+
181. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA updates prescribing information for Keytruda and Tecentriq [webpage]. Last Updated: 08/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617378.htm (accessed Jan. 3, 2019).
+
182. +
List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) [webpage]. Last Updated: 12/13/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm (accessed Feb. 21, 2019).
+
183. +
Bavencio® (avelumab) injection for intravenous use [product information]. Revised: 10/2018. EMD Serono, Inc.; Rockland, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf (accessed Feb. 21, 2019).
+
184. +
Avastin (bevacizumab) injection for intravenous use [product information]. Revised: 06/2018. Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125085s323lbl.pdf (accessed Mar. 3, 2019).
+
185. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves bevacizumab in combination with chemotherapy for ovarian cancer [webpage]. Last Updated: 06/13/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610664.htm (accessed Jan. 3, 2019).
+
186. +
Blincyto® (blinatumomab) injection for intravenous use [product information]. Revised: 3/2018. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf (accessed Mar. 3, 2019).
+
187. +
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse [FDA News Release]. March 29, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603151.htm (accessed Jan. 6, 2019).
+
188. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia [webpage]. Last Updated: 03/29/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm603171.htm (accessed Jan. 3, 2019).
+
189. +
Brentuximab vedotin (Adcetris®) [product information]. Revised: 11/2017. Seattle Genetics, Inc.; Bothell, WA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf (accessed Feb. 4, 2018).
+
190. +
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot [FDA News Release]. November 16, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626079.htm (accessed Jan. 4, 2019).
+
191. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves brentuximab vedotin for previously untreated sALCL and CD30-expressing PTCL [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626116.htm (accessed Jan. 3, 2019).
+
192. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: Brentuximab Vedotin[webpage]. Last Updated: 03/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm601947.htm (accessed Jan. 3, 2019).
+
193. +
FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy [FDA News Release]. March 20, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601935.htm (accessed Jan. 6, 2019).
+
194. +
Cinryze (C1 Esterase Inhibitor [Human]) For Intravenous Use, Freeze-Dried Powder for Reconstitution [product information]. Revised: 06/2018. Shire ViroPharma Incorporated; Lexington, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM129918.pdf (accessed Mar. 3, 2019).
+
195. +
Cimzia (certolizumab pegol) injection for subcutaneous use product information]. Revised: 05/2018 . UCB, Inc.; Smyrna, GA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf (accessed Mar. 3, 2019).
+
196. +
Coagadex® (Coagulation Factor X (Human)) Lyophilized Powder for Solution and Intravenous Injection [product information]. Revised: 09/2018. BPL USA, Inc.; Durham, NC. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM468127.pdf (accessed Mar. 3, 2019).
+
197. +
Darzalex (daratumumab) injection for intravenous use [product information]. Revised: 6/2018. Janssen Biotech, Inc.; Needham, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761036s014lbl.pdf (accessed Mar. 3, 2019).
+
198. +
Xgeva (denosumab) injection for subcutaneous use [product information]. Revised: 06/2018. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s191lbl.pdf (accessed Mar. 3, 2019).
+
199. +
Dupixent® (dupilumab) injection for subcutaneous use [product information]. Revised: 10/2018. Regeneron Pharmaceuticals; Tarrytown, NY. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf (accessed Mar. 3, 2019).
+
200. +
Imfinzi® (durvalumab) injection, for intravenous use [product information]. Revised: 2/2018. AstraZeneca Pharmaceuticals LP.; Wilmington, DE. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf (accessed Feb. 25, 2018).
+
201. +
FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing [FDA News Release]. February 16, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597217.htm (accessed Jan. 6, 2019).
+
202. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves durvalumab after chemoradiation for unresectable stage III NSCLC [webpage]. Last Updated: 02/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm597248.htm (accessed Jan. 3, 2019).
+
203. +
Empliciti® (elotuzumab) for injection for intravenous use [product information]. Revised: 11/2018. Bristol-Myers Squibb Co.; Princeton, NJ). Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761035s008lbl.pdf (accessed Mar. 3, 2019).
+
204. +
Magen  H, Muchtar  E. Elotuzumab: the first approved monoclonal antibody for multiple myeloma treatment. Ther Adv Hematol. 2016;7(4):187–195.
[PubMed: 27493709] ; PubMed Central PMCID: PMC4959642.
+
205. +
Hemlibra® (emicizumab-kxwh) injection for subcutaneous use [product information]. Revised: 10/2018. Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf (accessed Mar. 3, 2019).
+
206. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves emicizumab-kxwh for hemophilia A with or without factor VIII inhibitors [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm622564.htm (accessed Jan. 3, 2019).
+
207. +
Erelzi (etanercept-szzs) injection for subcutaneous use [product information]. Revised: 01/2018. SANDOZ; Princeton, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf (accessed Mar. 3, 2019).
+
208. +
McDonald  MR, Engelhardt  JM. Biologics blog: First Decision on Label Carve-Outs for Biosimilars Expected in Enbrel Litigation. June 18, 2018. Available from: Patterson Belknap Webb & Tyler LLP. http://www.biologicsblog.com/first-decision-on-label-carve-outs-for-biosimilars-expected-in-enbrel-litigation (accessed Mar. 3, 2019).
+
209. +
Gemtuzumab ozogamicin injection for intravenous use (MylotargTM) [product information]. Revised: 9/2017. Wyeth Pharmaceuticals, Inc.; Philadelphia, PA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761060lbl.pdf (accessed Feb. 18, 2018).
+
210. +
Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid [product information]. Revised: 3/2018. CSL Behring LLC.; Kankakee, IL. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM203150.pdf (accessed Mar. 3, 2019)
+
211. +
Xeomin (incobotulinumtoxinA) injection for intramuscular or intraglandular use [product information]. Revised: 7/2018. Merz North America, Inc.; Franksville, WI. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf (accessed Mar. 3, 2019).
+
212. +
Yervoy® (ipilimumab) injection for intravenous use [product information]. Revised: 7/2018. BRISTOL MYERS SQUIBB; Princeton, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf
+
213. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer [webpage]. Last Updated: 07/11/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm613227.htm (accessed Jan. 3, 2019).
+
214. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma [webpage]. Last Updated: 04/16/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604685.htm (accessed Jan. 3, 2019).
+
215. +
Mircera® (methoxy polyethylene glycol-epoetin beta) injection for intravenous or subcutaneous use [product information]. Revised: 6/2018. Vifor (International) Inc.; St. Gallen, Switzerland. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125164s078lbl.pdf
+
216. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves Mircera for anemia associated with chronic kidney disease in pediatric patients on dialysis [webpage]. Last Updated: 06/07/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610210.htm (accessed Jan. 3, 2019).
+
217. +
Opdivo (nivolumab) injection, for intravenous use [product information]. Revised: 1/2018. Bristol-Myers Squibb Company; Princeton, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s035s036s037s038s039lbl.pdf (accessed Mar. 1, 2018).
+
218. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA grants nivolumab accelerated approval for third-line treatment of metastatic small cell lung cancer [webpage]. Last Updated: 08/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617370.htm (accessed Jan. 3, 2019).
+
219. +
Keytruda® (pembrolizumab) injection, for intravenous use [product information]. Revised: 12/2018. Merck Sharp & Dohme Corp.; Whitehouse Station, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s037lbl.pdf (accessed Feb. 4, 2018).
+
220. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves pembrolizumab for Merkel cell carcinoma [webpage]. Last Updated: 12/19/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628867.htm (accessed Jan. 3, 2019).
+
221. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm625705.htm (accessed Jan. 3, 2019).
+
222. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves pembrolizumab in combination with chemotherapy for first-line treatment of metastatic squamous NSCLC [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm624659.htm (accessed Jan. 3, 2019).
+
223. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC [webpage]. Last Updated: 08/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617471.htm (accessed Jan. 3, 2019).
+
224. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL [webpage]. Last Updated: 06/13/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610670.htm (accessed Jan. 3, 2019).
+
225. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves pembrolizumab for advanced cervical cancer with disease progression during or after chemotherapy [webpage]. Last Updated: 06/13/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610572.htm (accessed Jan. 3, 2019).
+
226. +
Nplate® (romiplostim) for injection for subcutaneous use [product information]. Revised: 12/2018. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125268s163lbl.pdf (accessed Mar. 3, 2019).
+
227. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves romiplostim for pediatric patients with immune thrombocytopenia [webpage]. Last Updated: 12/14/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628525.htm (accessed Jan. 3, 2019).
+
228. +
Leukine® (sargramostim) injection for subcutaneous or intravenous use [product information]. Revised: 03/2018. Sanofi-Aventis U.S. LLC; Bridgewater, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf
+
229. +
Granix® (tbo-filgrastim) injection for subcutaneous use [product information]. Revised: 07/2018. Teva Pharmaceuticals USA, Inc.; North Wales, PA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125294s045lbl.pdf (accessed Mar. 3, 2019).
+
230. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma [webpage]. Last Updated: 05/03/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm606540.htm (accessed Jan. 3, 2019).
+
231. +
Actemra® (tocilizumab) injection for intravenous or subcutaneous use (ACTPenTM) [product information]. Revised: 12/2018 Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s125,125472s038lbl.pdf (accessed Mar. 3, 2019).
+
232. +
Vonvendi [von Willebrand factor (recombinant)] lyophilized powder for solution and intravenous injection[product information]. Revised: 2/2019. Baxalta US, Inc.; Lexington, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM476176.pdf (accessed Mar. 3, 2019).