The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese ...
Alvotech and Teva announced FDA acceptance of the Biologics License Application (BLA) for AVT05, a proposed biosimilar ...
The U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, ...
Objective To assess the efficacy and safety of golimumab over 104 weeks in patients with active ankylosing spondylitis. Methods At baseline, patients with active ankylosing spondylitis (n=356) were ...
Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria. Review of the applications is expected to by completed in Q4 2025, ...
Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the FDA has ...
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva ...
Results 29 RCTs involving 11 879 patients were included (14 for infliximab, 9 for adalimumab, 2 for golimumab, 1 for etanercept and 3 for certolizumab pegol). Of 7912 patients allocated to TNF-α ...
Objective Assess golimumab efficacy/safety through 5 years in patients with active ankylosing spondylitis (AS). Methods 356 patients with AS were randomly assigned to placebo, golimumab 50 mg or 100 ...