Statement from FDA Commissioner on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

FDA

7 March 2019 - We’re at a critical point for the future of biosimilars in the U.S. Millions of American patients stand to benefit from increased utilisation of these lower-cost, high-quality products. 

At the FDA, we’re committed to helping patients realize the public health benefits of a robust, competitive market for biosimilars.

Since the biosimilar pathway was established in 2010, there’s been debate about how biological products should be named, and whether a unique identifier such as a distinguishing suffix should be added to the proper (i.e., non-proprietary) names of biological products to help ensure strong pharmacovigilance.

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Michael Wonder

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Michael Wonder

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Medicine , US , Biosimilar , Nomenclature