Biotech company Alvotech S.A. (NASDAQ:ALVO) and Advanz Pharma, a UK-based pharmaceutical company with a focus on specialty, hospital and rare disease medicines, announced on Monday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human use (CHMP) has issued a positive opinion recommending approval of Gobivaz, Alvotech's proposed biosimilar to Simponi (golimumab).

The reference biologic is used to treat several chronic inflammatory diseases.

The CHMP recommendation covers 50 mg/0.5 mL and 100 mg/mL pre-filled syringes and autoinjectors for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis in adults, and juvenile idiopathic arthritis across the EU, Norway, Iceland, and Liechtenstein.

Gobivaz remains under EMA regulatory review, with a final decision by the European Commission pending. Alvotech is responsible for development and commercial supply, while Advanz Pharma holds exclusive commercialisation rights in Europe and manages registration.

Positive top-line results from a 2024 confirmatory clinical study showed comparable efficacy, safety, and immunogenicity of Gobivaz versus Simponi in moderate to severe rheumatoid arthritis patients. Earlier, in November 2023, a pharmacokinetic study demonstrated similar pharmacokinetics, safety, and tolerability in healthy adults. The EMA recommendation represents a key regulatory milestone for Gobivaz ahead of its potential European launch.