Home » Teva Calls for Flexible Biosimilars Standards as Public Meeting Begins
Teva Calls for Flexible Biosimilars Standards as Public Meeting Begins
Teva is calling on the FDA to adopt flexible standards once it approves a biosimilar for its initial indication, saying that no additional testing should be required to have a product deemed interchangeable or to approve additional indications. While acknowledging clinical trials should be required for the initial approval of a biologic, Teva, the world’s largest generic-drug maker, urged the agency at a public meeting to loosen its standards after that point. “If the mechanism of action is established very well, then I believe no additional data should be required [to support additional indications],” Riva Riven-Kreitman, senior vice president of global innovative R&D for Teva, said.
Drug Industry Daily
Drug Industry Daily
Upcoming Events
-
07May
-
14May
-
30May