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 ...
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 Approved for Pediatric Ulcerative Colitis

Findings showed 32% of patients achieved clinical remission (Mayo score ≤2 points, with no individual subscore >1) at week 6. The Food and Drug Administration (FDA) has expanded the approval of ...
FiercePharma

Alvotech plant issues foil another FDA review, this time for Teva-partnered Simponi biosimilar

Patients hoping to get their hands on a cheaper copycat of Johnson & Johnson’s fading anti-inflammatory blockbuster Simponi may have to wait for a few months more, thanks to an FDA inspection this ...
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 ...
Nasdaq

Alvotech Initiates Confirmatory Patient Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of Alvotech’s ...
Seeking Alpha

European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner

REYKJAVIK, ICELAND and LONDON, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients ...