President Kim Kyung-ah of Samsung Epis Holdings held a press briefing on the 14th at the JP Morgan Healthcare Conference in ...

Samsung Epis Holdings, the holding company of biosimilar drug developer Samsung Bioepis Co., aims to secure 20 biosimilars in ...

Amphastar Pharmaceuticals (NASDAQ:AMPH) executives used a conference presentation to highlight the company’s shift toward ...

It’s been more than ten years since the FDA signed off on the United States’ first biosimilar product, opening up what was ...

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...

The U.S. Food and Drug Administration (FDA) significantly revised its approach to biosimilar drug development on October 29. Specifically, FDA issued a draft guidance recommending when comparative ...

The Food and Drug Administration announced the approval of 127 innovator and biosimilar drugs in 2024, a notable decrease from the 149 approvals recorded in 2023. Despite the decline in overall ...

Biosimilars have yet to achieve their main purpose: to reduce the costs of complex biological drugs, as generics do for small molecules. Multiple barriers, from development costs to the contracting ...

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo WASHINGTON (Reuters) -The U.S.

AAM, the Biosimilars Council and NACDS commended the FDA for its announcement to make it faster and less costly to develop biosimilar medicines. The Association for Accessible Medicines and its ...

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, ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...