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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 statesIn trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…

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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…

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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…

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Key Biosimilars Events of August 2025  

Shots:       Biosimilars are developed to be highly similar of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea). Our…

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