Challenges to Biosimilar Substitution

20:00 EDT 25 Sep 2017 | JAMA

To the Editor We agree with Mr Hakim and Dr Ross that biosimilars in the United States are unlikely to yield widely expected cost savings and proffer an additional explanation: the frequency and complexity of biosimilar-related patent litigation have thus far resulted in too few marketed biosimilars. Only 2 of the 5 biosimilars approved by the US Food and Drug Administration (FDA) are now commercially available. As noted in the Viewpoint, prices for small molecule drugs drop 70% to 90% following generic approval, but these savings reflect competition after the entry of multiple generics, which is unlikely to occur anytime soon with biosimilars.

Original Article: Challenges to Biosimilar Substitution


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Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...