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FDA Draft Guidance on Biosimilars

02/09/2012

The US Food and Drug Administration (FDA) announced today three draft guidance documents pertaining to biosimilars, which are similar to and have no meaningful differences in terms of safety and effectiveness compared with FDA-approved biologic drugs. The FDA's rules will help companies have a better understanding of how they can get their products to market sooner than is usual. The Patient Protection and Affordable Care Act (ACA) included a provision for an abbreviated approval for biosimilars. The guidance includes scientific and quality considerations companies must abide by as well as questions and answers for companies trying to develop products. The FDA said it is seeking public comment on the guidelines. The full news release can be read at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291232.htm?source=govdelivery -Tim Casey

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