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Expert Analysis - Opinion

Time To Create A Viable Path To Biosimilar Interchangeability

By Kevin Nelson ( 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on demonstrating interchangeability for biosimilars essentially parrots the requirements the FDA laid out in its 2017 draft guidance....

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