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April 07, 2023

ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology

Authors: Gladys Rodriguez, MD https://orcid.org/0000-0001-9136-6304, Joan Mancuso, MA, Gary H. Lyman, MD, MPH https://orcid.org/0000-0002-0823-8086, Fatima Cardoso, MD https://orcid.org/0000-0002-6692-2249, Zeina Nahleh, MD https://orcid.org/0000-0002-2489-1501, Julie M. Vose, MD https://orcid.org/0000-0003-1015-7434, Julie R. Gralow, MD, FACP, FASCO, Michael Francisco, MPH https://orcid.org/0000-0002-1949-1060 michael.francisco@asco.org, and Shimere Sherwood, PhDAuthors Info & Affiliations
JCO Oncol Pract 19, 411-419(2023)
Volume 19, Number 7
DOI: 10.1200/OP.22.00783

 

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Abstract

As the voice of cancer care clinicians and the patients they serve, ASCO has taken steps to elevate awareness about biosimilar products and their use in oncology. In 2018, ASCO released its Statement on Biosimilars in Oncology which was subsequently published in the Journal of Clinical Oncology to serve as an educational tool which highlighted and provided guidance on several topical areas surrounding biosimilars. At the time of its publication, the US Food and Drug Administration (FDA) had approved eight biosimilar products for use in the United States, including one product for use as a supportive care agent in the cancer setting and two products for use in the treatment for cancer. This number has risen dramatically (40 approvals), with a total of 22 cancer or cancer-related biosimilar products approved since 2015. Recently, the FDA also approved the four interchangeable biosimilar products for diabetes, certain inflammatory diseases, and certain ophthalmic diseases. Given the current market dynamics and the regulatory landscape, this ASCO manuscript now seeks to propose several policy recommendations across the scope of value, interchangeability, clinician barriers, and patient education and access. This policy statement is intended to guide ASCO's future activities and strategies and serves to affirm our commitment to providing education to the oncology community on the use of biosimilars in the cancer setting.

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Publisher's Note

The article by Rodriguez et al entitled “ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology” (JCO Oncol Pract 10.1200/OP.22.00783) was published April 7, 2023, with an error.

In Table 1, the first sentence of the third row of the Patients and clinicians section read, “Physicians should discuss with their patients any proposed switching and whetherthis is the best treatment option according to evidence.” It should have read, “Physicians should discuss with their patients any proposed switching and whether this is the best treatment option according to evidence.”

 

This has been corrected as of April 19, 2023. The authors apologize for the error.

 

 

Authors' Disclosures of Potential Conflicts of Interest

ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.
Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Gladys Rodriguez

Stock and Other Ownership Interests: Novartis, Abbott Laboratories (I), Merck (I), AbbVie, Boston Scientific (I), Bristol Myers Squibb (I), Novo Nordisk (I), Pfizer (I), Lilly (I), CVS Health (I), United Health Group (I)
Consulting or Advisory Role: BMS, Pfizer

Gary H. Lyman

Honoraria: Sandoz, Seagen
Consulting or Advisory Role: G1 Therapeutics, BeyondSpring Pharmaceuticals, Fresenius Kabi, AstraZeneca, BMS (I)
Research Funding: Amgen (Inst)

Fatima Cardoso

Consulting or Advisory Role: Roche, Novartis, Pfizer, AstraZeneca, Teva, Astellas Pharma, Merus, Celgene, Eisai, Daiichi Sankyo, Genentech, Merck Sharp & Dohme, Sanofi, Pierre Fabre, Macrogenics, Amgen, GE Healthcare, GlaxoSmithKline, Mylan, Mundipharma, Samsung Bioepis, Medscape, Prime Oncology, IQvia, Gilead Sciences, Seagen, touchIME
Travel, Accommodations, Expenses: Pfizer, Roche, AstraZeneca, Novartis

Julie M. Vose

Honoraria: Acerta Pharma/AstraZeneca, Morphosys, Johnson and Johnson, MEI Pharma, Lilly, AbbVie, Merck
Research Funding: Celgene (Inst), Incyte (Inst), Acerta Pharma (Inst), Kite, a Gilead Company (Inst), Seagen (Inst), Novartis (Inst), Bristol Myers Squibb (Inst), AstraZeneca (Inst), Loxo, Epizyme

Julie R. Gralow

Consulting or Advisory Role: Genentech, Roche
No other potential conflicts of interest were reported.
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