In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. Based on alleged infringement of U.S. Patent No. 11,084,865 (“’865 patent”), Regeneron had requested a preliminary injunction that would…
On September 13, 2024, Celltrion announced that its Brazilian subsidiary won the Federal Government of Brazil’s bid to supply HERZUMA (trastuzumab-pkrb) for the fifth consecutive year, with around 660,000 vials to be delivered through 2025. According to the announcement, HERZUMA is the most prescribed trastuzumab drug launched in Brazil and…
Approval of Celltrion’s Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA (ustekinumab), for the treatment of several chronic inflammatory conditions. STEQEYMA is a human IL-12 and IL-23 antagonist indicated for…
There have been several recent developments in the PTAB with respect to Regeneron’s aflibercept-dosing patents. On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and 2023-1396) of six IPR final written decisions, finding claims of U.S. Patent Nos. 9,669,069 and 9,254,338 unpatentable. The IPRs…
On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the third BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz and Celltrion,…
In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron. Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 (“’865 patent”), generally directed to an ophthalmic formulation with…
FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s YESAFILI (aflibercept-jbvf) and Samsung…
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars. According to Sandoz, these…
On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA. This is the second BPCIA litigation regarding denosumab, following Amgen’s earlier litigation against Sandoz. Amgen and Sandoz stipulated to dismiss…
On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the brand names PROLIA and XGEVA, is indicated for the treatment of various diseases including osteoporosis…