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.