As we previously reported, on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved aflibercept biosimilar, PAVBLU (aflibercept-ayyh). A redacted version of the previously-sealed district court opinion was filed earlier this month. The same day the sealed order was entered denying the motion for a preliminary injunction, Regeneron filed a notice of appeal along with motions to expedite the appeal and for a temporary injunction and administrative preventing Amgen from launching PAVBLU pending resolution of the 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 indicated that “no extensions of time will be granted.”
As we previously reported, FDA approved Amgen’s PAVBLU on August 23, 2024, after previously approving aflibercept biosimilar applications filed by Biocon, Samsung Bioepis, Formycon, and Sandoz. On June 11, the District Court for the Northern District of West Virginia a permanent injunction against Biocon preventing launch of its aflibercept biosimilar (a redacted version of that order became available on Jun 21, 2024). The district court has also entered permanent (as to Biocon) and preliminary (as to Celltrion, Formycon, and Samsung) injunctions preventing product launch. Each of these injunction decisions is currently pending on appeal. Oral argument has been set for December 5 in the companioned appeals filed by Formycon and Samsung, and has not yet been scheduled in the companioned appeals filed by Biocon (in which briefing is complete) and Celltrion (in which Regeneron’s reply brief is due on November 11).
Stay tuned to Big Molecule Watch for further updates on the aflibercept BPCIA litigation.
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