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 ...
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 ...
Seeking Alpha

FDA accepts Teva, Alvotech BLAs for Simponi biosimilars

The FDA has accepted Alvotech (NASDAQ:ALVO) and Teva's (NYSE:TEVA) Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria. Review ...
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 ...
manilatimes

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

REYKJAVIK, ICELAND (December 22, 2025) - Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today ...
Seeking Alpha

Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz®, a First-in-Market Biosimilar to Simponi® (golimumab)

REYKJAVIK, Iceland and LONDON, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Alvotech (ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients ...