On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. AVZIZI is the fifth bevacizumab biosimilar approved by the FDA, behind Amgen’s MVASI (bevacizumab-awwb), approved in September 2017; Pfizer’s ZIRABEV (bevacizumab-bvzr), approved in June 2019; Amneal’s ALYMSYS (bevacizumab-maly), approved in…
As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts, asserting that Biogen sought FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra®…
Yesterday, Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (“Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts. In its Complaint, Genentech asserts that Biogen is seeking FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra® (tocilizumab).” Genentech…
This week, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of ACTEMRA (tocilizumab). BAT1806 is approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS), and is the first tocilizumab biosimilar approved by any…
Biogen Inc. (“Biogen”) recently announced that the European Medicines Agency (EMA) has accepted the marketing authorization application for BIIB800 (BAT1806), a biosimilar candidate referencing Roche’s ACTEMRA (tocilizumab). ACTEMRA, an anti-interleukin-6 receptor monoclonal antibody, is approved in Europe as an intravenous formulation for severe, active and progressive rheumatoid arthritis, juvenile idiopathic polyarthritis, active…
Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According to the press release, Bio-Thera will “maintain responsibility for development, manufacturing, and supply of BAT2206 [and] Hikma will have exclusive rights to commercialize…
Last week, Bio-Thera Solutions announced that a first patient has been dosed in its Phase III clinical trial study for ustekinumab biosimilar BAT2206. Stelara® (ustekinumab) is marketed by Johnson & Johnson Corp. for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn’s disease…
Biogen Inc. and Bio-Thera Solutions, Ltd. today announced positive Phase 3 results on BAT1806, a proposed biosimilar to ACTEMRA®/RoACTEMRA (tocilizumab). According to the Biogen press release, the study met its primary endpoints, demonstrating equivalent efficacy and comparable safety to the reference product in patients with moderate to severe rheumatoid arthritis…
This month, Biogen and Bio-Thera announced a commercialization and license agreement for their proposed tocilizumab biosimilar, currently in Phase 3 trials for the treatment of moderate to severe rheumatoid arthritis. BAT1806, a proposed biosimilar to Genentech’s ACTEMRA®, is an anti-interleukin-6 (IL-6) receptor monoclonal antibody indicated primarily for moderate to severe…
Last week, BeiGene and Bio-Thera Solutions announced that the companies had entered into a license, distribution, and supply agreement for BAT1706, Biothera’s Avastin® (bevacizumab) biosimilar, in China. According to the announcement, Bio-Thera has agreed to grant BeiGene the right to develop, manufacture, and commercialize BAT1706 in China, Hong Kong, Macau,…