Denosumab biosimilars enhance treatment access for postmenopausal osteoporosis, demonstrating equivalent efficacy and safety ...

Explore the safety and efficacy of switching to etanercept biosimilars, backed by clinical trials and real-world evidence for ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Industry groups are urging changes to the US Food and Drug Administration’s Biosimilar User Fee Amendments programme as talks ...

The FDA has approved Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab). Poherdy, as approved, is indicated for use in adults with HER2-positive breast cancer, ...

Michael Ellenberger, Aydin Harston Ph.D. With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S.

Samsung Epis Holdings, the holding company of biosimilar drug developer Samsung Bioepis Co., has pledged to put more effort ...

Every day, I think about the patients waiting for medicines that could change, or even save, their lives. For them, access is not a statistic. It is hope, health, and a chance for a better future.

Real-world data suggest anti-TNF biosimilars for juvenile idiopathic arthritis offer comparable efficacy and safety to their brand name counterparts. As high-cost originator biologics continue to ...

Fresenius Kabi, an Operating Company of Fresenius, and a leading provider of essential medicines and medical technologies, ...

The patent for Dupixent, called the "miracle atopic dermatitis treatment," will expire around 2031. Dupixent was co-developed by French drugmaker Sanofi and U.S. biotech Regeneron and posted $14.1 ...

Forbes contributors publish independent expert analyses and insights. Ge Bai is professor of accounting & health policy at Johns Hopkins. Biologic drugs, made from living organisms and usually taken ...