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14 BioPharm International eBook September 2019 www.biopharminternational.com Regulatory Sourcebook Biosimilars Kateryna_Kon - Stock.adobe.com FELIZA MIRASOL R ecent guidelines released by FDA empha- size the agency's efforts to ease the path toward regulatory approval for biosimilars and marks significant action taken by the agency to help promote competition in the biologic market. In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Considerations in Demonstrating Interchangeability with a Reference Product Guidance for Industry (2). Congress created an approval pathway in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are dem- onstrated to be "biosimilar" to or "interchangeable" with an FDA-approved biological brand, or reference product. The pathway is intended to benefit patients by making more treatment options available through biosimilar and interchangeable products, increasing access to life-saving medications, and potentially low- ering healthcare costs through competition. Because of patient need, well-functioning biosimilar and inter- changeable pathways are critical to the agency's broader efforts to improve competition. That's why FDA has developed and is working to implement a Biosimilars Action Plan that includes a suite of ongoing efforts to encourage innovation and competition among biolog- ics and the development of biosimilars (3). This article reviews FDA's recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosimilar development and characterization process. Biosimilar Quality Requirements