Alvotech application for Simponi biosimilar accepted by EMA
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- The European Medicines Agency has accepted a Marketing Authorization Application for AVT05, Alvotech’s (NASDAQ:ALVO) biosimilar to Johnson & Johnson’s (JNJ) TNF blocker Simponi (golimumab).
- Alvotech is expecting approval in Q4 2025.
- In April, the Icelandic drugmaker released top-line results of a study comparing efficacy, safety, and immunogenicity between AVT05 and Simponi in patients with moderate to severe rheumatoid arthritis.
- Alvotech, which is partnered with Advanz Pharma on AVT05, said it believes the application is the first globally for a Simponi biosimilar.