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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 ...
manilatimes

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 ...
Pharmabiz

Alvotech & Advanz Pharma receive marketing approval across the EEA for Gobivaz, a first-in-market biosimilar to Simponi

Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (Advanz Pharma), a UK headquartered ...
Seeking Alpha

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 European Economic Area for Gobivaz, Alvotech’s biosimilar to Simponi ...
Yahoo Finance

Alvotech faces FDA setback for its Simponi biosimilar AVT05

Alvotech’s inflammation-targeting biosimilar AVT05 has been rejected by the U.S. Food and Drug Administration (FDA) because of issues with the company’s manufacturing facility in Reykjavik, Iceland.
Benzinga.com

Alvotech Shares Plunge 33% After FDA Flags Issues

Alvotech (NASDAQ:ALVO) stock is trading lower on Monday, with a session volume of 2.32 million compared to the average volume of 395.34 thousand as per data from Benzinga Pro. • ALVO is at important ...
Nasdaq

Alvotech Shares Plunge As FDA Declines To Approve AVT05, A Biosimilar To Simponi

(RTTNews) - Shares of Alvotech (ALVO), a biotech company that manufactures biosimilar medicines, were trading 22.88% lower at $5.90 in pre-market trading on Monday, following disappointing regulatory ...
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 ...
Benzinga.com

FDA Expands Johnson & Johnson Ulcerative Colitis Drug Approval To Pediatric Patients

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s (NYSE:JNJ) Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at ...
WebMD

FDA Expands Approval of Simponi for Use in Pediatric Patients with Ulcerative Colitis

What Is Simponi, and Why Does It Matter? The FDA has approved Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kilograms (33 pounds).
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 ...