Gary H. Lyman, MD, FASCO
In an effort to more clearly outline the introduction of biosimilars into the US healthcare system, the FDA published the Biosimilars Action Plan: Balancing Innovation and Competition in July 2018. Though this plan focuses mainly on development and industry standards, there is necessary information for clinicians who will be prescribing these agents.
, Lyman, co-director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutchinson Cancer Research Center, interpreted the available information on biosimilars as it relates to the clinical oncology community.
OncLive: What are your thoughts on the guidance that the FDA has provided to clinicians thus far on biosimilars in oncology?
: There have been many efforts, including by the FDA, to inform clinicians about biosimilars. Their primary goal is to educate and hopefully reassure clinicians of the processes that they have in place, which are focused far more on preclinical data. These data must demonstrate that the molecule is very similar to the reference product, and that it behaves the same way in the laboratory and in animal models, as well as in limited clinical studies with pharmacokinetic and pharmacodynamic studies.
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