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

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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...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 constructivefeedback on Company’s analytical similarity strategy under the 351(k) biosimilar pathway Company continues to execute ...

Biologic copycats are making a bigger impact on drug prices as U.S. regulators open the doors wider, and new guidance could ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies.

The FDA plans to eliminate comparative clinical study requirements that currently add $24 million and up to eight years to ...

The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), for use in cancer patients at risk of infection due to chemotherapy. Filkri is indicated for patients receiving ...

Please provide your email address to receive an email when new articles are posted on . Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co.), a HER2 receptor antagonist and biosimilar to ...

The FDA has approved Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab). Poherdy, as approved, is indicated for use in adults with HER2-positive breast cancer, ...