On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), referencing Amgen’s PROLIA® and XGEVA®, respectively. These approvals make Fresenius the fourth company to receive FDA approval for a pair of denosumab biosimilars, joining Celltrion, Samsung, and Sandoz. Denosumab is a RANK ligand (RANKL)…
On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s denial of a preliminary injunction against Amgen Inc. (“Amgen”) in the ongoing aflibercept BPCIA litigation. On October 1, 2024, the district court denied Regeneron’s motion for…
On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen and Fresenius Kabi resolving the BPCIA litigation regarding Fresenius’s denosumab biosimilar, FKS518. The Order followed a stipulation by the parties…
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from launching CT-P42, its aflibercept biosimilar of EYLEA®. As we have previously reported, the Federal Circuit recently…
On February 28, Amgen, Inc. (“Amgen”) filed three petitions for inter partes review, challenging the validity of all claims in three patents assigned to Bristol-Myers Squibb Co. (“BMS”). The claims of all three patents are directed to methods of treating cancer with the combination of two checkpoint inhibitor immunotherapeutic antibodies,…
On February 4, 2025, HyClone Laboratories, LLC (“HyClone”), a cell culture media supplier, filed a Motion to Quash a subpoena issued by Amgen, Inc. (“Amgen”). The underlying subpoena was issued in Amgen’s ongoing denosumab BPCIA litigation against Fresenius Kabi USA, LLC and its affiliates (“Fresenius”) in the District Court for…
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd. (“Samsung”) and Formycon AG (“Formycon”) from marketing their aflibercept biosimilars of EYLEA®. The district court granted preliminary injunctions…
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the…
As we previously reported, in April of last year, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC brought a lawsuit against Pfizer and BioNTech in the District Court for the District of Delaware, alleging that the COVID-19 vaccine, Comirnaty®, infringed five of their U.S. patents directed to mRNA vaccine technology—specifically, U.S. Patent…
On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech, and Regeneron have all filed BPCIA complaints (sometimes several) asserting 20 or more patents. Does this reflect a…