New Developments in Amgen v. Apotex
Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®

New Developments in Amgen v. Apotex

Apotex petitioned the Supreme Court for a writ of certiorari on September 9, 2016, seeking review of the following two issues: (1) “[w]hether the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the BPCIA for the resolution of patent disputes . . . must also provide the reference product sponsor with a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A)”; and (2) “[w]hether the Federal Circuit improperly extended the statutory 12-year exclusivity period to [12.5] years by holding that a biosimilar applicant cannot give effective notice of commercial marketing . . . until it receives [FDA approval].” The Supreme Court denied the petition on December 12, 2016, without comment.

However, the questions Apotex presented are narrower than the cross-petitions taken from Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), which remain pending before the Supreme Court. The Court sought the opinion of the Acting Solicitor General concerning the Sandoz petitions, and in an amicus brief filed on December 7, 2016, the Acting Solicitor concluded that the Court should hear the case. If the Court agrees, it may address Apotex’s questions in the course of deciding Sandoz. Meanwhile, biosimilar applicants and other interested parties should continue to watch the Sandoz petitions and take any decisions into account in developing strategies.

For further information, please see the update to a recently published alert on this case.

By: Margaux L. Nair, Kenneth C. Liao, Trevor M. Gates, Peter Giunta

Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®

The United States biosimilars market is beginning to grow, with two recent approvals for biosimilars: Erelzi® and Amjevita®.

On August 30, 2016, the Food & Drug Administration (“FDA”) approved Sandoz’s application for a biosimilar of Enbrel®.  The product is called Erelzi and is the first biosimilar of etanercept to be approved by the FDA.  Like Enbrel, Erelzi is administered by injection and is approved to treat moderate to severe rheumatoid arthritis and moderate to severe plaque psoriasis, among other conditions.  Erelzi is approved as a biosimilar, not interchangeable, product. It is identified as etanercept-szzs.

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