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 ...

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 ...

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 ...

The European Medicines Agency (EMA) reports on progress to create a smoother, less wasteful biosimilar development process; and the World Health Organization (WHO) revises its biosimilar development ...

The US Food and Drug Administration (FDA) on Friday finalized additional questions and answers related to biosimilar development and the Biologics Price Competition and Innovation Act (BPCIA) and made ...

Alvotech acquires Xbrane's R&D operations and biosimilar candidate XB003 for ~$27M, expanding into Sweden's life sciences sector. Xbrane retains key preclinical assets, strengthens finances, and ...

(Reuters) -India's Biocon expects a 50% drop in costs for developing complex biosimilars as the United States has proposed to ease clinical testing for the drugs that make up more than 60% of its ...

WASHINGTON, March 10, 2026 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)(1) , a sweeping ...

Switzerland-based Sandoz , a leader in affordable medicines, today inaugurated a new biosimilar development center in ...