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

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...

Alvotech, Advanz Pharma secure European approval for Gobivaz, Simponi biosimilar

Alvotech (ALVO) and Advanz Pharma on Thursday said that the European Commission has granted marketing authorizations in the ...
PharmaTimes

Gobivaz approved across Europe as first Simponi biosimilar

“As the first biosimilar to Simponi (golimumab) to gain approval in the European market, we are committed to expanding access ...
Pharm Exec

FDA Approves Johnson & Johnson’s Simponi for Pediatric Ulcerative Colitis

Johnson & Johnson's Simponi gains FDA approval for treating pediatric ulcerative colitis, expanding options for young patients with this chronic condition. “Ulcerative colitis is a complex, lifelong ...
Yahoo Finance

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 (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients ...
The Pharma Letter

Alvotech and Advanz win EC approval for first Simponi biosimilar

Icelandic biosimilars company Alvotech and privately-held UK firm Advanz Pharma today announced that the European Commission ...
Monthly Prescribing Reference

Simponi Approved for Ulcerative Colitis

SIMPONI (Golimumab) 50mg/0.5mL solution for SC inj from Centocor Ortho Biotech The FDA has approved Simponi (golimumab for subcutaneous injection; Janssen Biotech) to induce and maintain clinical ...
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 ...
Healio

FDA expands Simponi Aria labeling to include fatigue in RA, PsA

Please provide your email address to receive an email when new articles are posted on . The FDA has approved a label update for Janssen’s golimumab to include language that treatment alongside ...
Healio

FDA approves Simponi Aria for polyarticular JIA, expands PsA indication to children

Please provide your email address to receive an email when new articles are posted on . The FDA has approved Simponi Aria for the treatment of polyarticular juvenile idiopathic arthritis in patients ...
Nasdaq

J&J Simponi Aria Gets FDA Nod for Pediatric Use in Arthritis

Johnson & Johnson JNJ announced that the FDA has granted approval to its TNF inhibitor, Simponi Aria for the treatment of children 2 years and older with active polyarticular course juvenile ...

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

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited ("Advanz Pharma"), a U ...