Sandoz announced the creation of a new biosimilar development, manufacturing and supply unit that will be headed by industry veteran Armin Metzger, who will join Sandoz on April 1.

The U.S. Food and Drug Administration (FDA)’s March 2026 update to its biosimilar Q&A guidance arrives at a critical inflection point for ...

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

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 guidance that codifies multiple regulatory ...

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 ...

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, ...

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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

March 9 (Reuters) - The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions ...

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.& | ...

Alvotech (NASDAQ:ALVO) draws attention as biosimilar innovation aligns with trends shaping the nasdaq composite.