Biological Filing Process to FDA

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Biologic filing is the process of submitting an application to the USFDA to request approval for a new biologic product. Biologics are a type of medicine that is made from living organisms or their products.


𝗧𝘆𝗽𝗲𝘀 𝗼𝗳 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗙𝗶𝗹𝗶𝗻𝗴𝘀

𝗧𝗵𝗲𝗿𝗲 𝗮𝗿𝗲 𝘁𝘄𝗼 𝗺𝗮𝗶𝗻 𝘁𝘆𝗽𝗲𝘀 𝗼𝗳 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗳𝗶𝗹𝗶𝗻𝗴𝘀:

  • 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗟𝗶𝗰𝗲𝗻𝘀𝗲 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 (𝗕𝗟𝗔): A BLA is an application for a new biologic product that has not been previously approved by the FDA.
  • 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗟𝗶𝗰𝗲𝗻𝘀𝗲 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗦𝘂𝗽𝗽𝗹𝗲𝗺𝗲𝗻𝘁 (𝗕𝗟𝗔𝗦): A BLAS is an application to make changes to an already approved biologic product.


𝗧𝗵𝗲 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗟𝗶𝗰𝗲𝗻𝘀𝗲 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 (𝗕𝗟𝗔) 𝗣𝗿𝗼𝗰𝗲𝘀𝘀

The BLA process is a complex and lengthy process that can take several years to complete.

  1. Preclinical Studies: The applicant must conduct preclinical studies to evaluate the safety and efficacy of the biologic product in animals.
  2. 𝗜𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗡𝗲𝘄 𝗗𝗿𝘂𝗴 (𝗜𝗡𝗗) 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻: The applicant must submit an IND application to the FDA to request permission to test the biologic product in human clinical trials.
  3. 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗦𝘁𝘂𝗱𝗶𝗲𝘀: The applicant must conduct clinical trials to evaluate the safety and efficacy of the biologic product in humans.
  4. 𝗕𝗟𝗔 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻: The applicant must submit a BLA to the FDA. The BLA must include a comprehensive set of data on the biologic product’s safety, efficacy, and manufacturing process.
  5. 𝗙𝗗𝗔 𝗥𝗲𝘃𝗶𝗲𝘄: The FDA will review the BLA and make a decision on whether or not to approve the biologic product.


𝗙𝗮𝗰𝘁𝗼𝗿𝘀 𝗔𝗳𝗳𝗲𝗰𝘁𝗶𝗻𝗴 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗙𝗶𝗹𝗶𝗻𝗴

  • 𝗧𝗵𝗲 𝗰𝗼𝗺𝗽𝗹𝗲𝘅𝗶𝘁𝘆 𝗼𝗳 𝘁𝗵𝗲 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗽𝗿𝗼𝗱𝘂𝗰𝘁: More complex biologic products may require more extensive preclinical and clinical studies.
  • 𝗧𝗵𝗲 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗼𝗳 𝗱𝗮𝘁𝗮: The FDA may require additional data if it is not satisfied with the data submitted in the BLA.
  • 𝗧𝗵𝗲 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗲𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁: The regulatory environment can change over time, which may affect the requirements for biologic filing.

𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗙𝗶𝗹𝗶𝗻𝗴 𝗥𝗲𝘀𝗼𝘂𝗿𝗰𝗲𝘀

  • 𝗧𝗵𝗲 𝗖𝗕𝗘𝗥 𝗕𝗟𝗔 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁: This guidance document provides general information on the BLA process.
  • 𝗧𝗵𝗲 𝗖𝗕𝗘𝗥 𝗕𝗟𝗔 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗙𝗼𝗿𝗺 (𝗙𝗼𝗿𝗺 𝗙𝗗𝗔 𝟯𝟱𝟲𝗵): This form is used to submit a BLA to the FDA.
  • 𝗧𝗵𝗲 𝗖𝗕𝗘𝗥 𝗕𝗟𝗔 𝗥𝗲𝘃𝗶𝗲𝘄 𝗠𝗮𝗻𝘂𝗮𝗹: This manual provides detailed information on the FDA’s review of BLAs.

Biologic filing is a complex and important process that is essential for the development of new biologic products.


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Resource Person: Amit Singh

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