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# FDA Guidance on Moving Protein NDAs to BLAs
- URL: https://www.fdaweb.com/fda-guidance-on-moving-protein-ndas-to-blas/
- Published: 2016-03-11T12:00:00.000Z
- Updated: 2026-09-15T02:43:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135056

> FDA has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM490264.pdf?ref=fdaweb.com) (XXINSERT LINKXXX) entitled “Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) ” that describes the agency’s approach for transferring protein products that were approved as NDAs to licensed BLAs that adhere to the regulatory scheme of the Public Health Service Act effective 3/23/2020\. The agency explains that the BPCI Act changed the statutory authority under which these protein products will be regulated by amending the statutory definition of a “biological product” in the PHS Act to include a “protein (except any chemically synthesized polypeptide).”  
>  
> The draft guidance notes that the agency will not approve any pending or tentatively approved NDAs for a biological product under the FD&C Act after 3/23/2020\. It also provides recommendations to sponsors of proposed biological products intended for NDA that may not receive final approval by the 2020 deadline. “Sponsors with product-specific questions should contact the relevant review division within the Office of New Drugs in FDA’s CDER regarding the development of a biological product intended for submission in a marketing application under the FD&C Act (during the transition period ending on March 23, 2020) or under section 351(a) or 351(k) of the PHS Act, as appropriate,” it says.  
>  
> Additionally, FDA says that any unexpired exclusivity associated with an approved NDA for a biological product would be erased after the 2020 deadline. However, any unexpired orphan drug exclusivity would continue to apply to the drug for the protected use after the deadline.