Seeking Alpha

Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, a Proposed Biosimilar for Simponi® (golimumab)

The confirmatory clinical safety and efficacy study for AVT05, biosimilar candidate to Simponi ® and Simponi Aria ® (golimumab), met its primary endpoint in patients with moderate to severe rheumatoid ...
JD Supra

FDA Issues Complete Response Letter for Alvotech’s Simponi® (golimumab) Biosimilar AVT05

On November 2, 2025, the FDA issued a complete response letter (CRL) for Alvotech’s abbreviated Biologics License Application (aBLA) for its proposed Simponi ® (golimumab) biosimilar AVT05. The CRL ...
Yahoo Finance

Alvotech announces European launch of first-in-market biosimilar to Simponi® (golimumab) globally by partner Advanz Pharma

REYKJAVIK, Iceland, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients ...
Hosted on MSN

Alvotech begins European rollout of first-ever Simponi biosimilar Gobivaz

The latest update is out from Alvotech ( (ALVO)). On December 22, 2025, Alvotech reported that launches have begun across Europe for Gobivaz (golimumab), its biosimilar to Johnson & Johnson’s Simponi ...
Nasdaq

Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab)

REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...