4 November 2019 - As the number of biosimilar approvals continues to rise in the US, the number of biosimilar launches continues to lag, but experts explained how this is more of a legal issue than a problem with the US Food and Drug Administration (FDA).

Chad Landmon, partner at Axinn, Veltrop & Harkrider LLP, offered an overview on Monday at the Association of Accessible Medicines’ conference in Bethesda, MD, of the biosimilar “patent dance,” which is the convoluted and often uncertain process by which the patent issues are resolved ahead of a biosimilar’s launch.

Unlike on the generic side, which has an Orange Book of patent and exclusivity data, biosimilar companies do not have an administrative record of the date of first licensure or exclusivity period, Landmon explained. He also touched on other limitations of FDA’s Purple Book and how to improve it with legislation.

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