The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in litigation with Sandoz Inc.
The FDA’s action came in response to a citizen petition in which Amgen urged regulators to require biosimilar applicants to certify that they will follow information-sharing provisions of the See more +
The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in litigation with Sandoz Inc.
The FDA’s action came in response to a citizen petition in which Amgen urged regulators to require biosimilar applicants to certify that they will follow information-sharing provisions of the Biologics Price Competition and Innovation Act, which was part of the Affordable Care Act. In a Polsinelli Podcast, IP attorney Morgan Kirley discusses the decision and other aspects of biosimilars. To learn more about the firm's capabilities in this area, go to www.polsinelli.com
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