The U.S. Food and Drug Administration (FDA) today announced action to make it faster and less costly to develop biosimilar medicines, which are lower-cost alternatives to expensive biologic drugs used ...

Accelerate Polpharma Biologics biosimilar program from IND to commercial manufacturing Includes a commitment to producing for US FDA BLA submission Expand global market presence through launch in EU ...

This podcast originally premiered on The Center for Biosimilars ® in video format. This version is the audio-only version. In this insightful podcast episode, host Giuseppe Randazzo, senior vice ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

(RTTNews) - Alvotech (ALVO) announced on Thursday that it has acquired Xbrane Biopharma AB's R&D operations and biosimilar candidate XB003, further enhancing its position in the biosimilars ...

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 (Reuters) -The U.S. Department ...

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 An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...