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Review
. 2022 Mar;18(3):177-186.
doi: 10.1200/OP.21.00771. Epub 2022 Jan 18.

Use of Biosimilar Medications in Oncology

Zeina Nahleh  1 , Gary H Lyman  2 , Richard L Schilsky  3 , Douglas E Peterson  4 , Scott T Tagawa  5 , Mariana Chavez-MacGregor  6 , R Bryan Rumble  7 , Shilpi Gupta  8
Affiliations
Review

Use of Biosimilar Medications in Oncology

Zeina Nahleh et al. JCO Oncol Pract. 2022 Mar.

Abstract

Purpose: The increased number and expanded utilization of biosimilars raise important considerations for their safe and appropriate use in oncology practice. This report provides an update on currently approved oncology biosimilars and identifies current knowledge gaps in the management of patients with cancer.

Methods: An Expert Panel was convened to review the medical literature and to provide a practical summary of currently approved biosimilar therapeutics for cancer treatment or supportive care in the United States.

Results: A total of 17 cancer or cancer-related biosimilar products have been approved by the US Food and Drug Administration since 2015. Despite years of clinical experience with oncology biosimilars, variance in their use persists. ASCO supports that biosimilars and reference products are considered equally efficacious for the purpose of inclusion in ASCO clinical practice guideline recommendations.

Conclusion: The use of biosimilars might provide competitive, lower-cost alternatives to biologics used in cancer care, and specific mention in ASCO guidelines and other evidence products is supported where appropriate.

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Conflict of interest statement

Gary H. LymanConsulting or Advisory Role: G1 Therapeutics, Samsung Bioepis, BeyondSpring Pharmaceuticals, Sandoz, Jazz Pharmaceuticals, Partner Therapeutics, E.R. Squibb Sons, LLC, MSD, Seattle Genetics, Kallyope, TEVA, Spectrum Pharmaceuticals, Frensenius KabiResearch Funding: Amgen (Inst) Richard L. SchilskyLeadership: Clarified Precision MedicineConsulting or Advisory Role: Cellworks, Scandion Oncology, Bryologyx, Illumina, EQRxResearch Funding: AstraZeneca (Inst), Bayer (Inst), Bristol Myers Squibb (Inst), Genentech/Roche (Inst), Lilly (Inst), Merck (Inst), Pfizer (Inst), Boehringer Ingelheim (Inst), Seattle Genetics (Inst)Open Payments Link: https://openpaymentsdata.cms.gov/physician/1138818/summary Douglas E. PetersonStock and Other Ownership Interests: Allergan (I), Celgene (I), Gilead Sciences (I), Procter & Gamble (I), Roche (I), Bristol Myers Squibb (I), Johnson & Johnson (I)Honoraria: PierianDxConsulting or Advisory Role: Amgen, PSI Pharma Support America, Applied Glycan-Oral Health, AEC Partners, BrainCool, Medicxi Ventures (UK) LLP, Boston MedTech Advisors Scott T. TagawaConsulting or Advisory Role: Medivation, Astellas Pharma, Dendreon, Janssen, Genentech, Endocyte, Immunomedics, Karyopharm Therapeutics, AbbVie, Tolmar, QED Therapeutics, Amgen, Sanofi, Pfizer, Clovis Oncology, Novartis, Genomic Health, POINT Biopharma, Blue Earth Diagnostics, Seattle Genetics, AIkido Pharma, 4D Pharma, Clarity Pharmaceuticals, Gilead Sciences, Telix Pharmaceuticals, Bayer, Myovant Sciences, Convergent TherapeuticsResearch Funding: Lilly (Inst), Sanofi (Inst), Janssen (Inst), Astellas Pharma (Inst), Progenics (Inst), Millennium (Inst), Amgen (Inst), Bristol Myers Squibb (Inst), Dendreon (Inst), Rexahn Pharmaceuticals (Inst), Bayer (Inst), Genentech (Inst), Newlink Genetics (Inst), Inovio Pharmaceuticals (Inst), AstraZeneca (Inst), Immunomedics (Inst), Novartis (Inst), AVEO (Inst), Boehringer Ingelheim (Inst), Merck (Inst), Stem CentRx (Inst), Karyopharm Therapeutics (Inst), AbbVie (Inst), Medivation (Inst), Endocyte (Inst), Exelixis (Inst), Clovis Oncology (Inst), POINT Biopharma (Inst)Patents, Royalties, Other Intellectual Property: Patent Royalty from Immunomedics/GileadTravel, Accommodations, Expenses: Sanofi, Immunomedics, AmgenUncompensated Relationships: ATLAB Pharma, Phosplatin Therapeutics Mariana Chavez-MacGregorEmployment: MD Anderson Physicians NetworkHonoraria: Pfizer, EisaiConsulting or Advisory Role: Roche/Genentech, AstraZeneca, Novartis, Pfizer, asofar, Genomic Health, Exact Sciences, AstraZeneca/Daiichi SankyoResearch Funding: Novartis (Inst)Expert Testimony: Abbott Laboratories, PfizerTravel, Accommodations, Expenses: PfizerOther Relationship: RocheUncompensated Relationships: Legacy Healthcare Services, The Hope FoundationNo other potential conflicts of interest were reported.

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