Goodwin
As previously reported, the District Court for the Northern District of West Virginia, on September 24, 2024 denied Regeneron’s motion for a preliminary injunction to prevent Amgen from launching PAVBLU (aflibercept – ayyh), its FDA-approved biosimilar aflibercept. A redacted version was filed earlier in the month of the previously sealed district court opinion. On September 25, the Federal Circuit entered an order temporarily enjoining Amgen from launching PAVBLU “until further notice while the court considers the motion for an injunction pending appeal.” On September 25, the Federal Circuit entered an order temporarily enjoining Amgen from launching PAVBLU “until further notice while the court considers the motion for an injunction pending appeal.”
Yesterday, the Federal Circuit issued its decision denying Regeneron’s request for an injunction pending appeal, stating that, “[w]ithout prejudicing the ultimate disposition of the issues on appeal, we conclude that Regeneron has not established that an injunction pending appeal is warranted.” The Federal Circuit indicated that it would “however, expedite briefing and place the case on the January 2025 oral argument calendar.” Amgen’s response brief will be due November 4, 2024 and Regeneron’s reply will be due November 13, 2024. The Federal Circuit stated that “no extensions will be granted.”
As previously reported, FDA approved Amgen’s PAVBLU on Aug 23, 2024 after previously approving biosimilar applications submitted by Biocon. Samsung Bioepis. Formycon. and Sandoz. On June 11, the District Court for the Northern District of West Virginia issued a permanent injunction to Biocon, preventing the launch of its biosimilar aflibercept (a redacted version of this order was made available on June 21, 2024). The district court also entered preliminary (as regards Celltrion, Formycon and Samsung) and permanent (as regards Biocon) injunctions that prevented product launch. Oral argument has been scheduled for December 5 in the companioned appeals filed by Formycon and Samsung, but not yet in those filed by Biocon (in which briefing is complete) and Celltrion (in which Regeneron’s reply brief is due on November 11). Oral arguments have been scheduled for December 5, in the companioned appellations filed by Formycon, Samsung and Celltrion. The briefing for Biocon has been completed. Regeneron has yet to schedule oral arguments in the companioned appellations filed by Biocon and Celltrion.
