Clinical Implications of the Recommended Approval of 2 Biosimilars: Interview with Allan Gibofsky, MD

Rheumatology Advisor—July 28, 2016

Rheumatology Advisor writer Tori Rodriguez reports on the U.S. Food and Drug Administration's Arthritis Advisory Committee's motion to recommend the approval for two biosimilar products. Allan Gibofsky, MD, a rheumatologist at Hospital for Special Surgery, comments on the latest developments regarding biosimilars and its impact to patient care.

Dr. Gibofsky explains, "Biosimilars are defined as similar to the original product "notwithstanding minor differences" in inactive components. Don't think of a biosimilar as a generic biologic — unlike a generic molecule, these can't be bioidentical. I think when the biosimilar market becomes more robust and patients are switched from the original to the biosimilar, there may be differences in efficacy that we won't know about until after the fact. Even when the pharmacokinetics are the same, the inactive ingredients can be such that patients may experience different efficacy or reactivity, particularly when there are multiple switches."

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