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,…
Yesterday, India-based Cadila Pharmaceuticals announced the launch of its bevacizumab biosimilar for the Indian market under the brand name BEVARO. Bevacizumab is a biosimilar of Genentech’s AVASTIN and is indicated for the treatment of multiple cancers, including ovarian cancer, glioblastoma multiforme, colorectal cancer, breast cancer, lung cancer, cervical cancer, and…
On June 16, 2020, Shanghai Henlius Biotech, Inc. announced that HLX04-mCRC03, a phase 3 clinical trial of bevacizumab biosimilar HLX04, had successfully met its primary endpoint. The study compared the safety, efficacy and immunogenicity of HLX04 and Avastin in combination with oxaliplatin and fluoropyrimidine-based chemotherapy as first-line treatment in patients…
Earlier this week, Bio-Thera Solutions announced the initiation of the Phase III clinical study for its tocilizumab biosimilar, BAT1806. According to the press release, the Phase III clinical study will enroll over 65 patients at more than 45 sites around the world, and will compare the safety and efficacy of…
During the first weeks of 2019 a number of biosimilar developers announced updates regarding their plans for the future. Bio-Thera Solutions Partners with Cipla for Bevacizumab Biosimilar Candidate On January 14, 2019, Bio-Thera Solutions Ltd announced that it has entered into a licensing agreement with Cipla Limited for BAT-1706, its…