Aaron Lukas, a member of Cozen O'Connor's Intellectual Property department, discusses this topic in the Pharmaceutical Law & Industry Report. The Supreme Court’s recent ruling in Sandoz Inc. v. Amgen Inc., is the high Court’s first attempt to interpret provisions of the Biologics Price Competition and Innovation Act (BPCIA). The ruling helps ensure that biosimilar products will enter the U.S. market quickly after FDA approval. However, the Supreme Court can do nothing to improve the slow rate of FDA approvals, or to ensure that consumers actually reap the benefit of biosimilar competition. Here is a look back at the past 18 months of activity in biosimilars and an analysis of what impact the Supreme Court’s recent decision is likely to have on future products.
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