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Alvotech and Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the EC Approval to Treat Several Chronic Inflammatory Diseases

Shots: 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.…
November 20, 2025

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Alvotech & Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the MHRA’s Approval to Treat Several Chronic Inflammatory Diseases

Shots: 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…
November 7, 2025

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Kashiv Biosciences submits a BLA to the US FDA and receives EMA MAA acceptance for ADL-018 (Biosimilar, Xolair) 

Shots:  Kashiv BioSciences submitted a BLA to the US FDA and received EMA MAA acceptance for ADL-018, a proposed biosimilar to Xolair (omalizumab)  ADL-018 is a humanized mAb biosimilar to Xolair (omalizumab), designed to block IgE binding on mast cells and basophils. Xolair is approved for CSU (≥12 yrs), moderate-to-severe asthma (≥6 yrs), chronic rhinosinusitis…
October 6, 2025

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Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases

Shots: 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…
September 24, 2025

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STADA Receives the CHMP’s Positive Opinion for Kefdensis and Zvogra (Biosimilar, Prolia & Xgeva)  

Shots:  The CHMP has recommended Kefdensis and Zvogra, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders  Kefdensis (biosimilar to Prolia) received CHMP approval for treating osteoporosis in high-risk postmenopausal women and men with an increased risk of fractures. Zvogra (biosimilar to Xgeva) received CHMP approval for preventing skeletal events…
September 19, 2025

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Alvotech Reports Marketing Approval of Three New Biosimilars Across Japan 

Shots:  Alvotech has reported that its partner Fuji Pharma has received Japanese approval for three biosimilars: AVT03 (Biosimilar, Ranmark), AVT05 (Biosimilar, Simponi), and AVT06 (Biosimilar, Eylea)   In Japan, AVT03 (denosumab-biosimilar to Ranmark/Xgeva) was approved for bone lesions from multiple myeloma or solid tumor metastases; AVT05 (golimumab biosimilar to Simponi) for rheumatoid arthritis Pts. who are…
September 19, 2025

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