FDA Issues Three Draft Guidances for Biosimilars

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After much anticipation, the Food and Drug Administration (FDA) today issued not one but three new draft guidance documents intended to facilitate the submission of marketing applications for biosimilars.

The three draft guidances can be accessed through the following links:

• “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009” (Biosimilars Q&A) is available online at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM273001.pdf.

• “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” (Biosimilars Scientific Guidance) is available online at http://www.fda.gov/downloads/Drug /GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf.

• “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product” (Biosimilars Quality Guidance) is available online at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM291134.pdf.

FDA is encouraging the submission of comments on all three of these draft guidances within the next 60 days. Note, however, that each draft guidance document is assigned a unique docket number for the submission of comments.

Please see full alert below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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