Today, in the Genentech v. Amgen BPCIA litigation concerning Amgen’s MVASI (bevacizumab-awwb) biosimilar product, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the district court’s denial of Genentech’s motions to enjoin sales of MVASI in the United States. MVASI is an FDA-approved biosimilar of Genentech’s AVASTIN.
As we previously reported, in July 2019, Genentech filed an emergency motion and motion for a temporary restraining order premised on the legal theory that Amgen was out of compliance with the “notice of commercial marketing” provision of subsection (l)(8)(A) of the BPCIA. Although Amgen had provided notice in October 2017 of its intent to begin commercial marketing of MVASI in at least 180 days (i.e., no earlier than April 2019), Genentech posited that the notice was ineffective because Amgen had subsequently supplemented its aBLA with additional manufacturing and labeling information, so the biosimilar that Amgen was seeking to launch was a different “biological product” under the BPCIA. Such supplementation of its aBLA, according to Genentech, required Amgen to provide a new notice of commercial marketing and wait another 180 days before it could market MVASI. The district disagreed, finding that the original notice was still legally effective and “the fact that Mvasi was the subject of the original application approved by the FDA in September 2017 does not make it a different biological product than the Mvasi that was the subject of the supplements to the application approved by the FDA in December 2018 and June 2019.”
Immediately following the decision, Amgen launched MVASI in the United States, and Genentech filed an appeal. Both the district court and the Federal Circuit declined Genentech’s interim requests for an injunction pending resolution of the appeal.
In today’s Federal Circuit opinion, the Court similarly ruled in Amgen’s favor, concluding that “Amgen’s October 6, 2017, letter, which notified Genentech of Amgen’s intent to commercially market Mvasi at least 180 days before its July 2019 launch, satisfied Section 262(l)(8)(A).” The Court reasoned that despite Amgen’s “later supplements to its applications adding a manufacturing facility and changing its drug product label, Amgen’s biological product, Mvasi, did not change.” Siding with biosimilar makers, the Federal Circuit held that 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.” The Federal Circuit concluded that the statutory text was unambiguous on this point.