On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia. According to the partnership agreement, Tabuk will hold the marketing authorization and be responsible to manufacture, register, import, and market…
On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsen’s STELARA. STEQEYMA is approved for subcutaneous injection or intravenous infusion in adult and pediatric patients for treatment of various psoriatic conditions, Crohn’s disease, and ulcerative colitis. STEQEYMA is the seventh ustekinumab biosimilar…
On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech, and Regeneron have all filed BPCIA complaints (sometimes several) asserting 20 or more patents. Does this reflect a…
The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars. The CHMP recommended approval of four biosimilars developed by Celltrion: (1) AVTOZVMA (tocilizumab), for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced…
This Monday, Bio-Thera Solutions announced that it would be expanding its Latin American biosimilar marketing partnership with SteinCares. Previously, Bio-Thera and SteinCares had agreed to a partnership whereby Bio-Thera, a commercial-stage biopharmaceutical company, granted SteinCares, a Latin American specialty healthcare company, exclusive rights to market two of Bio-Thera’s biosimilars in…
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…
On November 25, 2024, Intellia Therapeutics announced that its CRISPR-based therapy, nexiguran ziclumeran (nex-z, NTLA-2001), received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for treatment of hereditary transthyretin (ATTR) amyloidosis with polyneuropathy (ATTRv-PN). Nex-z is an in vivo gene editing therapy designed as a single-dose treatment to inactivate…
On December 3, 2024, Accord BioPharma, Inc. (“Accord”), the U.S. specialty division of Intas Pharmaceuticals, Ltd. (“Intas”), announced an agreement to acquire Coherus BioSciences, Inc.’s UDENYCA® (pegfilgrastim-cbqv) business. UDENYCA®, the only biosimilar to Amgen’s NEULASTA® in the United States, is administered the day after chemotherapy treatment to decrease the incidence…
Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 On December 4, 2024, Duality Biologics (“DualityBio”), a clinical-stage biotech company focusing on the discovery and development of next-generation antibody-drug conjugate (“ADC”) therapeutics, announced an exclusive option agreement with GSK for DualityBio’s ADC candidate,…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…