Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

March 7, 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 utilization 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 … (leggi tutto)