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 ...
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 ...
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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 ...
Healio

Proposed biosimilar shows equivalence to golimumab in rheumatoid arthritis

Please provide your email address to receive an email when new articles are posted on . Alvotech’s AVT05 showed therapeutic equivalence with golimumab in DAS28-CRP score change at 16 weeks. The ...
Monthly Prescribing Reference

Simponi Aria

If needed, Simponi Aria may be stored at room temperature up to 77⁰F (25⁰C) for a maximum single period of 30 days in the original carton to protect from light. Once Simponi Aria has been stored at ...
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 ...
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 ...
Morningstar

Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT2506, a Proposed Biosimilar to Simponi®

GUANGZHOU, China, July 16, 2025 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today ...
Morningstar

Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2506, a Proposed Biosimilar to Simponi®, in the European Union

GUANGZHOU, China, Feb. 7, 2025 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today ...