On March 31, 2023, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved MAILISHU, a denosumab biosimilar, for the treatment of osteoporosis in…
On March 31, 2023, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved MAILISHU, a denosumab biosimilar, for the treatment of osteoporosis in…
On Monday April 17, 2023, Celltrion announced that it has launched VEGZELMA (bevacizumab-adcd, an AVASTIN biosimilar) in the United States for the treatment of several cancers, including…
On March 21, 2023, Sandoz, announced FDA approval of its citrate-free high-concentration formulation (HCF) of its biosimilar HYRIMOZ® (adalimumab-adaz) injection. HYRIMOZ® is approved to…
As we previously reported, Magistrate Judge Hall issued a Report and Recommendation (“R&R”) on February 10, 2023 denying Amgen’s motion to dismiss Regeneron’s antitrust claims in…
For the first time in decades, the Supreme Court will consider patent law’s “enablement” requirement, in Amgen Inc. v. Sanofi. That requirement is often a key point in litigation when…
As we previously reported, on March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from…
On March 6, 2023, Coherus Biosciences announced FDA approval of an autoinjectable version of Udenyca, Coherus’ biosimilar to Amgen’s Neulasta (pegfilgrastim). Udenyca (pegfilgrastim-cbqv) was…
On March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale,…
On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®. BEKEMV® is a biosimilar candidate referencing Alexion’s biological product…
Last week, Fresenius Kabi announced the launch of STIMUFEND (pegfilgrastim-fpgk), a biosimilar to Amgen’s NEULASTA, in the United States. As we previously reported, STIMUFEND was Fresenius…