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Supreme Court Analysis: Ruling A Victory For Biosimilar Developers
The Supreme Court handed biosimilar drug developers a clear victory this week in its decision on Amgen Inc. v. Sandoz Inc.
In its decision, the high court considered the provisions of the federal Biologics Price Competition and Innovation Act of 2009 (the "Act"), specifically, the Act's requirement that biosimilar developers, prior to commercially marketing a biosimilar, must give 180 days' notice to the manufacturer of the reference, i.e. brand-name, drug. The issue presented to the Court was whether a developer can give this six-month notice prior to having its biosimilar license application approved by the Food and Drug Administration. The Court ultimately held that biosimilar developers may give such notice prior to FDA approval.
The Court's decision has a significant impact on the length of time that the original manufacturer has exclusive rights to a biologic. Under the Act, the original manufacturers of a biologic have a 12-year exclusivity period during which biosimilar applications may not be approved by the FDA.By giving the marketing notice during the application process, biosimilar manufacturers avoid needing to wait another six months after the 12-year exclusivity period prior to commercially marketing the drug.By extension, the decision should also open the market for affordable, life-saving drugs.