Bevacizumab – USA

On Jul. 06, 2020, Federal Circuit dismissed Genentech’s emergency motion and a motion for a temporary restraining order & held that Amgen is not required to provide again notice of commercial marketing for its supplements.

Amgen filed a aBLA with USFDA pursuant to market a biosimilar version of Avastin—Mvasi. USFDA approved Mvasi on Sept. 14, 2017. On Oct. 6, 2017, Amgen sent a letter pursuant to 42 U.S.C. § 262(l)(8)(A) notifying Genentech of its intent to commercially market Mvasi starting no earlier than 180 days from the date of the letter. But after that Amgen filed supplements to its Mvasi application to add a manufacturing facility & to update drug label. By July 8, 2019, Amgen decided it would commercially launch Mvasi, intending to market it immediately. Genentech then filed motions in the District of Delaware seeking to preclude Amgen from commercially marketing Mvasi “until such time as Amgen . . . provides notice of commercially marketing”. The district court denied motions, reasoning that Amgen’s October 2017 commercial marketing notice for Mvasi satisfied Section 262(l)(8)(A)’s notice requirements. Genentech appealed.

Section 262(l)(8)(A) recites:

The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under sub-section (k).

Federal Circuit said that the statute under Section 262(l)(8)(A) makes clear that the biosimilar applicant must provide notice to the reference product sponsor prior to commercially marketing “the biological product”. The definition of biological product provided under Section 262 does not include supplements. Genentech argued that the phrase “licensed under sub-section (k)” is defined “by particular manufacturing facilities and labeling”. Federal Circuit disagreed & said that Section 262(k), not Section 262(l)(8)(A), details the contents and requirements for biosimilar licensure, including manufacturing and labeling. And this interpretation is consistent with the Supreme Court’s decision in Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017) (Sandoz II). In Sandoz II, the Supreme Court explained that the term “licensed” in Section 262(l)(8)(A) simply means that the product must be licensed on the date of the first commercial marketing, not that each supplemental application results in a new license requiring the biosimilar applicant provide further notice. Thus, Genentech’s interpretation, which would impose several timing requirements where each supplement necessarily triggers another notice requirement, is inconsistent with the statute and with Sandoz II. A biosimilar applicant that has already provided Section 262(l)(8)(A) notice regarding its biological product need not provide another notice for each supplemental application concerning the same biological product.