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