On January 19, 2026, Hikma announced the U.S. launch of ENOBY (denosumab-qbde) and XTRENBO (denosumab-qbde)—denosumab biosimilars referencing Amgen’s PROLIA and XGEVA, respectively. As recited in the announcement, “[d]enosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer that has spread to the bone, and treating unresectable giant cell tumor of…
On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc. (together, “Genentech”) and Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co….
On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis. TYRUKO® was approved by FDA in August 2023 to treat all indications covered by Biogen’s TYSABRI®, including relapsing forms of MS and Crohn’s…
On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of denosumab biosimilars approved by the FDA. Both OSVYRTI® and JUBEREQ® are approved for all indications of their respective reference products. Denosumab is a…
This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the reference product at the pharmacy without intervention of the prescribing healthcare provider. On October 29, Fresenius Kabi announced that the FDA granted an interchangeability designation for CONEXXENCE® and BOMYNTRA®…
On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Biocon Biologics, Inc., Biocon Biologics UK Limited, Biocon Biologics Limited, and Biosimilars Newco Limited (collectively, “Biocon”) after Amgen and Biocon executed a Confidential…
On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.” PYZCHIVA®—a biosimilar of Janssen’s STELARA®—is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six…
Back in May 2023, Alnylam brought suit against Pfizer and BioNTech in the District of Delaware, alleging infringement of patents directed to vaccine lipid nanoparticle technology. On August 12, 2024, Chief Judge Connolly issued a memorandum opinion construing the claim term “vaccine” in one of the asserted patents (U.S. Patent…
On July 26, 2024, Genzyme Corp. (a wholly owned subsidiary of Sanofi) filed suit in the District Court for the District of Delaware against Sarepta Therapeutics, Inc., and Sarepta Therapeutics Three, LLC (collectively, “Sarepta”). Genzyme alleges that Sarepta’s manufacture and sale of Elevidys® (delandistrogene moxeparvovec-rokl)—a gene therapy treatment for Duchenne…
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned IPRs filed by Celltrion where the PTAB found all challenged claims of U.S. Patent Nos. 8,580,264 and 10,874,677 were…