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The EC has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis (with methotrexate), PsA (± methotrexate), ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis (with methotrexate) across 30 EEA states
Approval was based on extensive data, incl.…
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The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion
Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while…
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Bio-Thera Solutions has entered into an exclusive commercialization & license agreement with Intas Pharmaceuticals for BAT2506, a biosimilar version of Simponi (golimumab), for Canada
The agreement expands their Feb 2025 deal, under which Intas holds US commercialization rights for BAT2506, while Bio-Thera handles its development & manufacturing
BAT2506 is an IgG1 monoclonal antibody that targets…
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The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states
In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…
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Matchpoint & Novartis have entered into an exclusive option & license agreement to develop & commercialize oral covalent inhibitors targeting a transcription factor in inflammatory diseases using Matchpoint’s ACE platform
As per the deal, Matchpoint will lead all research activities through development candidate selection with funding from Novartis. Matchpoint will receive $60M in upfront & funding…

