On September 11, 2025, the U.S. Food and Drug Administration (FDA) issued new guidance for the development of therapeutic protein biosimilars, focusing on comparative analytical assessment and quality ...

Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...

Pfizer on Tuesday told Focus that it’s halting the development of five preclinical biosimilar assets, though the company will continue to market three biosimilars and develop five other biosimilars in ...

Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Drug & Device Team explores the Food and Drug Administration’s updated draft guidance that eases biosimilar development by allowing greater use of ...

Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...

One week after releasing its 11-part biosimilar action plan, the US Food and Drug Administration (FDA) announced it will hold a public hearing to gather input on how it can facilitate the development ...

U.S. regulators have proposed loosening some of the clinical trial requirements for companies to win approval for biosimilar versions of insulin products ...

Alvotech, a biotech firm focused on biosimilar medicine development, announced the acquisition of Xbrane Biopharma’s R&D operations and a biosimilar candidate named XB003, aimed at extending its ...

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 ...

The updated guidance allows originators to cite existing comparative data, not exclusively from the United States, for clinical pharmacokinetic testing. This updated guidance in conjunction with ...