In Amgen v. Apotex, Judge Cohn of the Southern District of Florida recently enjoined Apotex from selling its proposed biosimilar of Amgen’s Neulasta for 180 days following FDA approval. In Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015), the first and only appellate decision interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA), the Federal Circuit held that under 42 U.S.C. § 262(l)(8)(A), a biosimilar maker can only give effective 180-day notice of commercial marketing after FDA has licensed its product. Apotex argued that the notice of commercial marketing is only mandatory under Amgen v. Sandoz if the biosimilar maker fails to provide its abbreviated biologics license application (aBLA) to the innovator company under the BPCIA’s pre-suit information exchange provisions. Judge Cohn disagreed and held that a notice of commercial marketing is mandatory under Amgen v. Sandoz whether the biosimilar maker provided the innovator company with its aBLA or not.
Apotex filed a notice of appeal and moved to expedite the proceedings, arguing that “FDA may approve its product(s) within the next several months.” Amgen opposed, noting that Apotex refused to produce any evidence suggesting that approval of its proposed Neulasta biosimilar is imminent. Apotex replied that it does not and could not know when its product will be approved because there is no fixed deadline for approval and FDA has not informed Apotex when its biosimilar application might be approved. Notably, Apotex’s reply made no mention of any upcoming advisory committee meeting for its proposed biosimilar and it did not provide any update on the status of its application, such as whether it was rejected and had been resubmitted. (Apotex’s biosimilar application was accepted for review more than a year ago and filed earlier still; FDA’s goal is to act on any original biosimilar application within 10 months of filing, and to act within 6 months on an application that has been resubmitted after rejection of the original application.) Apotex also argued that the issues on appeal are relevant to other pending cases (pointing to Amgen’s case against Hospira and Janssen’s case against Celltrion and Hospira) and that expeditious resolution will “facilitate prompt resolution, or at the very least be instructive, of this issue in those cases as well.”
Apotex filed its opening appeal brief on December 30, 2015. The same day, Judge Linn granted Apotex’s motion, but largely left Amgen’s time to file its opposition brief intact rather than adopting the schedule proposed by Apotex. Amgen’s opposition brief is due on February 4, 2016 and Apotex’s reply is due by February 12, 2016. The case will be placed on the next available oral argument calendar.