Alvotech (ALVO) and Advanz Pharma Holdco announced that the European Medicines Agency's Committee for Medicinal Products for Human use has adopted a positive opinion recommending approval for Gobivaz, Alvotech's proposed biosimilar to Simponi, a biologic used to treat several chronic inflammatory diseases. Simponi and Simponi Aria are registered trademarks of Johnson & Johnson. Gobivaz remains under EMA regulatory review with a final decision by the European Commission pending.
Alvotech is responsible for the development and commercial supply of Gobivaz. Advanz Pharma is responsible for registration and has exclusive rights for commercialization in Europe.
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