Biopharma Firms Upset With FDA’s Draft Biosimilar Interchangeability Guidance

Several biopharmaceutical firms are asking the FDA for further clarification on several aspects of the regulatory agency’s draft biosimilar interchangeability guidance. The draft calls on drug firms to use “switching studies” to determine whether alternating between a biosimilar and its reference product two or more times will affect the safety or efficacy of treatment.

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