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Amgen Loses Bid to Block a Biosimilar Version of Its Best-Selling Drug
Wall Street Journal (03/20/15) Silverman, Ed
U.S. District Court Judge Richard Seeborg has denied Amgen's bid to block Novartis from selling a low-cost copy of its Neupogen drug. The ruling emphasizes that federal law does not allow brand-name drugmakers to find procedural reasons to delay the introduction of biosimilars, and it could allow developers of biosimilars to more quickly market medicines approved by the Food and Drug Administration (FDA). The issue centered around an interpretation of the Biologics Price Competition and Innovation Act, which addresses the procedures a drugmaker must follow for regulatory approval of biosimilars. In Amgen Inc. vs. Sandoz Inc., Amgen charged that the Novartis unit Sandoz had failed to follow rules by not providing Amgen with required information. Amgen also maintained that Sandoz should have shared a marketing application submitted to the FDA as well as manufacturing plans and six-month notice of its plans to market an approved biosimilar. Sandoz insisted that the law did not require it to provide such information to Amgen, and Judge Seeborg agreed.
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