Add Yahoo as a preferred source to see more of our stories on Google. The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...
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 Biosimilars Market is set to witness a CAGR of 15% in the next 5 years. Impending patent expiry of blockbuster biologics, ...
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 ...
The global unit will be headed by Armin Metzger, who will join Sandoz on April 1, 2026. Metzger, who will be president of biosimilar development, manufacturing and supply, joins Sandoz from ...
Cancer therapeutics and orphan drugs are no longer niche areas. Specialty drugs are now a significant portion of the ...
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 ...
While FDA’s draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant ...
(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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results