Fed. Circ. Amgen-Sandoz Ruling Extends Biologics Exclusivity

By Jeff Overley (July 21, 2015, 12:07 PM EDT) -- The Federal Circuit on Tuesday partly reversed Sandoz Inc.'s victory over Amgen Inc. in a major battle over requirements of the Affordable Care Act's biosimilars pathway, interpreting an advance-notice provision in a way that effectively extends exclusivity for brand-name biologics by six months.

According to the decision, biosimilar makers must wait for product approval by the U.S. Food and Drug Administration before they can supply a required 180-day advance notice of commercial marketing to a branded company. That conclusion overturned a district court decision and essentially adds 180 days of exclusivity to the 12 years that branded biologics already receive....

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