The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance ...

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 ...

March 9 (Reuters) - The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions ...

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

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

The Inflation Reduction Act (IRA) has reshaped how Medicare covers and reimburses prescription drugs. For the first time, the ...

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

The FDA has proposed new rules to speed up the development of biosimilar drugs, aiming to reduce the costs of biologic ...

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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

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

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 ...

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.