Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a complaint on January 3, 2024, against Samsung Bioepis Co. Ltd. (“Samsung”) in the U.S. District Court for the District of Delaware, alleging infringement of 6 patents under the BPCIA based on Samsung’s submission of an aBLA for…
On October 27, Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration approved LOQTORZI (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment…
As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product, ELEVIDYS (delandistrogene moxeparvovec-rokl). Sarepta and Catalent each…
On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”). According to the petition, the ’992 patent claims “encompass a formulation comprising the VEGF inhibitor protein,…
On July 14, Dong-A ST announced that the European Medicines Agency accepted its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar referencing STELARA (ustekinumab). STELARA is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The MAA submission was based on the results of a…
On July 12, Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s) announced that the U.S. Food and Drug Administration (FDA) accepted for review its Biologics License Application (BLA) for DRL_RI, a biosimilar referencing RITUXAN (rituximab). RITUXAN is currently FDA-approved for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic…
On February 24, the USPTO extended the written comment period for Joint USPTO–FDA Collaboration Initiatives until March 10, 2023. As we previously reported, the USPTO requested public input on areas for USPTO-FDA collaboration and engagement in response to President Biden’s Executive Order to “help ensure that the patent system, while incentivizing…
On January 24, Alvotech and Bioventure, a subsidiary of GlobalOne Healthcare Holding LLC, announced that the Saudi Food & Drug Authority has approved SIMLANDI, a biosimilar referencing HUMIRA (adalimumab), in Saudi Arabia. According to the press release, Bioventure is Alvotech’s exclusive strategic partner for the commercialization of SIMLANDI in the…
Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe On November 14, Stelis Biopharma Limited (Stelis), the biologics arm of Strides Pharma Science Limited, announced that its first biosimilar product KAULIV received a positive recommendation from European Medicines Agency (EMA) for granting market authorization. KAULIV is a biosimilar referencing…
Organon, a global woman’s health company, recently announced its launch of two biosimilar products in Canada. On November 7, Organon announced the launch and availability of AYBINTIO in Canada. AYBINTIO is a biosimilar product referencing AVASTIN (bevacizumab) and is approved for adults with certain aggressive forms of cancers, including metastatic…