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HomeOtherBig Change in FDA process for Biologics:

Big Change in FDA process for Biologics:

 “The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) requires that a marketing application for a “biological product” (that previously could have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)) must be submitted as a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act).”

This requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020.” as per FDA
It means, after 23-Mar-2020, we will have only BLA pathway for biological product. This 10 year period (2009 to 2020) is given to sponsor so that they can be prepared for this transition.

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Table of Contents

Background of this change:

As we know that some protein (Not chemically synthesized) products; for example  insulin and insulin analogs, human growth hormone (HGH), reproductive hormones, pancreatic enzymes, used to be  approved by new drug applications (NDAs) pathway under the FD&C Act. As per new changes, these products will be shifted to BLA pathway.

Proteins (NDA pathway) before 23-Mar-2020 
Proteins (BLA pathway) After 23-Mar-2020
You can read about biological product approval pathways in below article https://lifepronow.com/blog/2019/12/27/biologics-approval-pathways-in-usa/

Lets Learn about the details of this new process:

For Proposed Product:
After 23-Mar-2020, Biological products which could have been approved by NDA pathway, will be approved by BLA applications. Sponsor needs to submit an application under section 351 of the PHS Act. Based on the nature of product, application can be either:

  1. 351(a) BLA ( “stand-alone” BLA) for new product
  2. 351(k) BLA for a proposed biosimilar product or a proposed interchangeable product.

For approved products:,
“The BPCI Act requires that an approved marketing application for a “biological product” under section 505 of the FD&C Act be deemed to be a license for the biological product (i.e., an approved BLA) under section 351 of the PHS Act on March 23, 2020, and regulated under the PHS Act.”  as per FDA.

  • It means already approved biologics under NDA pathway will be considered as approved (deemed to be a license)  under BLA pathway after 23-Mar-2020.
  • After the transition, sponsor can seek approval of bio-similar or interchangeable biologics of  these transitioned products.

More guidance about interpretation of this act can be found in below link under resource section: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/deemed-be-license-provision-bpci-act


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