Head explodes: On March 23, 2020, the Biologics
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Posted On: 06/01/2020 9:46:08 PM
Head explodes:
On March 23, 2020, the Biologics Price Competition and Innovation Act of 2009 requires that an approved application for a “biological product” under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) shall be deemed to be a license for the biological product (i.e., an approved Biologics License Application (BLA)) under section 351 of the Public Health Service Act (PHS Act). FDA has assigned the same application number used for the approved new drug application (NDA) to the deemed BLA. However, an application holder whose NDA was deemed to be a BLA will need to ensure that the listing information for the biological product is updated in FDA’s electronic Drug Registration and Listing System (eDRLS) between March 23, 2020, and June 30, 2020, to reflect a change in the prefix of the application number (from “NDA” to “BLA”) (see 21 CFR 207.57(b)(1)(iv)). Until this occurs, the change in application type will not be reflected in this database, even though the application will be correctly described as a BLA in other databases.
FDA also notes that the deeming of an approved NDA to be a BLA and the corresponding update of the eDRLS listing information for the biological product to change the prefix for the application number will not result in the need for a new National Drug Code (NDC) number with a new product code. Accordingly, in the absence of other changes made by the application holder that would require a new NDC number, biological products approved under the FD&C Act will retain their current NDC number after the NDA is deemed to be a BLA.
For a list of approved NDAs for biological products that were deemed to be BLAs, please see FDA’s List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020.
For additional information please see FDA’s webpage on The “Deemed to be a License Provision of the BPCI Act”, including FDA’s guidance on The “Deemed to Be a License” Provision of the BPCI Act Questions and Answers.
On March 23, 2020, the Biologics Price Competition and Innovation Act of 2009 requires that an approved application for a “biological product” under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) shall be deemed to be a license for the biological product (i.e., an approved Biologics License Application (BLA)) under section 351 of the Public Health Service Act (PHS Act). FDA has assigned the same application number used for the approved new drug application (NDA) to the deemed BLA. However, an application holder whose NDA was deemed to be a BLA will need to ensure that the listing information for the biological product is updated in FDA’s electronic Drug Registration and Listing System (eDRLS) between March 23, 2020, and June 30, 2020, to reflect a change in the prefix of the application number (from “NDA” to “BLA”) (see 21 CFR 207.57(b)(1)(iv)). Until this occurs, the change in application type will not be reflected in this database, even though the application will be correctly described as a BLA in other databases.
FDA also notes that the deeming of an approved NDA to be a BLA and the corresponding update of the eDRLS listing information for the biological product to change the prefix for the application number will not result in the need for a new National Drug Code (NDC) number with a new product code. Accordingly, in the absence of other changes made by the application holder that would require a new NDC number, biological products approved under the FD&C Act will retain their current NDC number after the NDA is deemed to be a BLA.
For a list of approved NDAs for biological products that were deemed to be BLAs, please see FDA’s List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020.
For additional information please see FDA’s webpage on The “Deemed to be a License Provision of the BPCI Act”, including FDA’s guidance on The “Deemed to Be a License” Provision of the BPCI Act Questions and Answers.
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