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Rulings Help Address Confusion of 2009 Biosimilar Approval Pathway Law

Aug 20, 2015 | Mike | Corporate Governance, Drug policy, Health Law, Law, Legislation, Pharmaceuticals | No Comments

The Federal Circuit Court of Appeals issued two rulings related to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a law that established an abbreviated regulatory approval process for follow-on biological products, also referred to as biosimilars. Similar to the Hatch-Waxman Act’s expedited approval pathway for generic drugs, the BPCIA established an approval process for biosimilars that did not require the same rigorous requirements as that of the original biologic product approval application. In Amgen Inc. v. Sandoz Inc., the three-judge panel came down on separate sides of the two issues, handing both companies a respective victory. On the first issue, the court sided with Sandoz, the biosimilar applicant, that they were not mandated to disclose its application and manufacturing process to Amgen, the reference product sponsor. On the second issue, the court sided with Amgen that Sandoz cannot give the required 180-day notice of commercial marketing until it has received approval from the U.S. Food and Drug Administration. The rulings illustrate the complexity of the BPCIA, which could leave the door open for future review. Read more.

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