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By Jacob C. Jones and David G. Barker On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA approval. This means that, in some circumstances, manufacturers can begin marketing biosimilars immediately after FDA approval. The Biologics Price Competition and Innovation Act of 2009 (BPCIA) required Sandoz to give Amgen notice 180 days before selling its biologic Zarxio, an FDA approved biosimilar drug that relied on the prior approval of Amgen’s Neupogen. Sandoz Read More »
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