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Time To Create A Viable Path To Biosimilar Interchangeability

Law360 (May 21, 2019, 4:14 PM EDT) -- Without a viable path for interchangeability, many companies have been hesitant to pursue biosimilars. The Biologics Price Competition and Innovation Act, therefore, hasn't lived up to its promise of lowering the cost of biological drugs. The U.S. Food and Drug Administration's newly issued guidance on demonstrating interchangeability for biosimilars essentially parrots the requirements the FDA laid out in its 2017 draft guidance.

Even with this new guidance, applicants are still facing uncertainty in demonstrating interchangeability. In order to achieve the promise of the BPCIA and increase biosimilar uptake, it is time for Congress to create an interim step to interchangeability....

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