Biosimilars Panel Highlights Need for Patience, Transparency

by Amanda Conschafter, blog editor

A Politico Pro-Health panel on biosimilars invited straight talk from FDA Director Janet Woodcock, MD, who acknowledged the need for a safe, incremental approach to adopting biosimilar medications. Sponsored by the Alliance for Patient Access, “Biosimilars: Can They Break Through?” featured panelists from industry, medicine, law, regulation and nonprofit organizations to discuss policy issues that affect these medical therapies’ safety and accessibility.

Politico Health Care Editor Joanne Kenen (right) and Politico Health Care Reporter Sarah Karlin (left) are joined by Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, Food and Drug Administration (second from left) David Rosen, FDA Practice Group Leader, Co-Chair Life Sciences Industry Team, Foley & Lardner (third from left) Bert Liang, M.D., Ph.D., M.B.A., CEO, Pfenex, and Chair, Biosimilars Council (fourth from left) Kimberly Greco, Director of Global Regulatory and R&D Policy, Amgen (third from right) and Seoyoung Kim, M.D., Assistant Professor of Medicine, Harvard Medical School (second from right) during Politico’s Pro Health Care Report: Biosimilars: Can They Break Through? at the Mayflower Hotel in Washington, DC, Wednesday, November 18, 2015. (Photo by Rod Lamkey Jr.)

The need for traceability in the event of adverse patient responses featured prominently in the panel’s discussion of distinct names and Medicare billing codes for biosimilars. Emphasizing the challenges of tracing Dr. Woodcock described the challenges FDA has encountered in tracing adverse events for generic medications. Even when the investigation “went into patients’ medicine cabinets,” she noted, the FDA still couldn’t tell which version of the drug had been dispensed.

Dr. Woodcock also emphasized the need for a gradual approach to the policies governing biosimilars. “It’ll be incremental,” Dr. Woodcock explained, adding “We’re just starting.” Kim Greco of Amgen, which develops both innovator and biosimilar therapies, echoed this sentiment, urging regulators to “Follow the science and plan for the long term.

But developing physicians’ trust in biosimilars will be no small task. Dr. Woodcock explained that getting physicians to feel confident that biosimilars will perform for their patients will be “a heavy lift.” AfPA Chairman David Charles, MD, emphasized in his opening remarks that, to instill confidence, regulators must provide clinicians comprehensive and transparent information. When asked about naming and labeling issues, Dr. Woodcock echoed the need for distinguishable names. “We have to be able to know if a biosimilar is causing problems we didn’t anticipate…We need to in some way to be able to track and identify those [drugs].”

To learn more, watch Biosimilars: Can They Break Through?


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