FDA Voice blog (05/14/15) Christl, Leah

The Food and Drug Administration (FDA) has taken new steps to help manufacturers develop biosimilars and provide more treatment options for patients, while also possibly lowering treatment costs. In recent weeks, the agency has released four guidances for industry to help manufacturers navigate the new terrain of biosimilar development. One assists companies in demonstrating that a proposed product is indeed biosimilar to an existing biologic product, and is intended to provide clarity to manufacturers about the expectations for a biosimilar development program. A second focuses on the analytical studies that demonstrate that the product is "highly similar" to an existing biological product, which supports the demonstration of biosimilarity. A third guidance answers common questions about the biosimilar development and application process and contains information intended to provide a better understanding of the law that allows biosimilars development. A fourth, still in draft form—which means FDA is accepting public comment—answers a variety of additional questions that have arisen regarding the biosimilars development process.

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