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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.
Recent guidelines released by FDA emphasize 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. The agency is working to implement a Biosimilars Action Plan that includes a suite of ongoing efforts to encourage innovation and competition among biologics and the development of biosimilars.
eBook: Regulatory Sourcebook, September 2019
When referring to this article, please cite it as F. Mirasol, “Biosimilar Quality Requirements," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).