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U.S. Supreme Court Opinion Should Speed the Launch of Biosimilars

Posted on Jun 14, 2017 in Blog

The U.S. Supreme Court on June 12, 2017 issued an opinion in the consolidated cases of Sandoz Inc. v. Amgen Inc. et al. and Amgen Inc. et al. v. Sandoz Inc. which should result in more competition in the biologicals market more quickly.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated pathway toward licensing of biological products by the FDA. Under Section 262(l) of the BPCIA, an applicant that seeks FDA approval of a biological product based on its similarity to an approved product (“reference product”) must provide its application and manufacturing information to the manufacturer of the reference product within 20 days of the date the FDA notifies the applicant that it has accepted the application for review. The first question at issue in the cases was whether this obligation on the applicant is enforceable by injunction.

The Court held that the requirement of notifying the manufacturer of the corresponding biologic is not enforceable by injunction under federal law, but remanded the cases to the Court of Appeals for the Federal Circuit to determine whether an injunction is available under state law.

The second question at issue was whether an applicant must provide notice after the FDA licenses its biosimilar, or if it may also provide effective notice before being licensed. Section 262(l)(8)(A) of the BPCIA provides that the applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biosimilar. The 180-day notice does not refer to the timing of FDA licensing. Thus, the Court further held that an applicant may provide notice to the manufacturer before or after obtaining a license from the FDA.  By providing the notice before being licensed, manufacturers of biosimilars can be prepared for launch upon receipt of FDA approval, and avoid the 180-day post-approval waiting period applicable under the Federal Circuit’s earlier ruling, which was reversed by this decision.

– by David M. Tener


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