ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology

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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“…Some barriers to more extensive uptake globally identified include patient and prescriber perception of biosimilars, lack of awareness, and issues regarding interchangeability and substitution of biosimilars [27]. Recently updated American Society of Clinical Oncology (ASCO) guidelines support interchangeable use of biologics, and note that to date, no immunogenicity concerns for any approved oncology biosimilars have been identified by the FDA [28]. As experience with using biosimilars has grown substantially, hesitation from oncologists may reduce over time [22].…”