The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

March 9 (Reuters) - The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions ...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 (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 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 today announced another major step in its initiative to streamline the development of biosimilar medicines, ...

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.

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate endangerment finding ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the hopes of lowering drug prices.

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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Drug & Device Team explores the Food and Drug Administration’s updated draft guidance that eases biosimilar development by allowing greater use of ...

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.& | ...