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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

FDA provided constructive feedback on Company’s analytical similarity strategy under the 351(k) biosimilar pathway Company continues to execute its analytical program and plans to request a BPD Type ...

March 9 (Reuters) - The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions of complex biologic medicines, aiming to lower the cost of treatments for ...

Sandoz has not minced words about the massive, yet largely untapped opportunity biosimilar makers are presented with as dozens of branded medicines inch toward the patent cliff in the next decade.& | ...

Week-18 ORR equivalence was achieved for HD204 vs reference bevacizumab (48.7% vs 46.5%), with both risk ratio and risk ...

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 ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the ...

Primary endpoint of Overall Response Rate at Week 18 met, demonstrating clinical equivalence in patients with advanced ...