On January 12, 2026, Sanofi announced that the European Commission approved its Teizeild (teplizumab) for delaying progression to stage 3 type 1 diabetes (“T1D”) in adults and children eight years and older who have stage 2 T1D. Teizeild marks the first disease-modifying treatment for T1D available in the EU. Sanofi…
On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adults and children aged 6 years and older with allergic fungal rhinosinusitis (“AFRS”), with a target action date of February 28, 2026….
On August 1, 2025, a UK Court of Appeal upheld the validity of Moderna’s European Patent No. 3,590,949 (“EP’949”) in a dispute with Pfizer and BioNTech. The decision affirmed a July 2024 UK High Court ruling finding that EP’949 is both valid and infringed by Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty®. EP’949…
In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars. Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without intervention of the prescribing health care provider. On May 23, Celltrion announced that the FDA granted an expanded interchangeability designation…
On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s HLX15 (daratumumab), a biosimilar candidate to Janssen’s Darzalex® & Darzalex Faspro®. HLX15 (daratumumab) is a recombinant anti-CD38 fully…
Jazz Pharmaceuticals’s ZIIHERA® On November 20th, Jazz Pharmaceuticals announced that the FDA has approved ZIIHERA® (zanidatamab-hrii) on an accelerated basis for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. “The approval of Ziihera, which previously received Breakthrough Therapy…
Daewoong Pharmaceutical announced on October 31 that it has signed a joint sales agreement with Celltrion Pharm to market CT-P41 in Korea. CT-P41, Celltrion’s biosimilar of Amgen’s PROLIA, is scheduled to launch in Korea in the first half of 2025. Under the agreement, Daewoong and Celltrion will jointly promote CT-P41…
Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion’s SOLIRIS. EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. After…
As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court for the District of Delaware. Alexion’s complaint alleged infringement of six patents under the BPCIA based on Samsung’s submission of its…
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. ENHERTU, which is now FDA-approved for five indications, is a…