Alongside the approval of Ponlimsi, the FDA is reviewing a BLA for TEV-45779, a biosimilar candidate for Xolair, covering all currently approved indications.
Prescriptions for an adalimumab biosimilar among new users rose from 0% to 24% after CVS Caremark added it to its formulary, ...
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Teva's Prolia biosimilar gets FDA nod, Xolair filing accepted
Teva Pharmaceutical Industries Ltd. TEVA announced that the FDA has approved its biosimilar to Amgen’s AMGN blockbuster drug, ...
Week-18 ORR equivalence was achieved for HD204 vs reference bevacizumab (48.7% vs 46.5%), with both risk ratio and risk ...
South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing ...
Please provide your email address to receive an email when new articles are posted on . Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co.), a HER2 receptor antagonist and biosimilar to ...
Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. As of today, July 1st, Cyltezo (adalimumab-adbm) is commercially ...
The US Food and Drug Administration (FDA) has further updated its regulatory framework around biosimilar medicines in a bid to reduce drug prices on home soil. Through the new draft guidance, the FDA ...
Teva’s biosimilar, PONLIMSI™, is now FDA-approved across all indications of the reference product, Prolia® (denosumab), to ...
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