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Alvotech's Gobivaz Biosimilar Receives Positive EMA Opinion for Marketing Approval.
ByAinvest
Monday, Sep 22, 2025 4:32 am ET1min read
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval for Gobivaz, Alvotech's proposed biosimilar to Simponi (golimumab), a biologic used to treat chronic inflammatory diseases. The CHMP recommends granting marketing authorization for Gobivaz in the European Union, Norway, Iceland, and Lichtenstein. Alvotech is responsible for development and supply, while Advanz Pharma has exclusive commercialization rights in Europe.
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