It is well known that, the Food and Drug Administration (FDA) has been working to implement the transition of biological products which are currently approved as drug products and are ‘deemed to be licensed’ as biologics under the Public Health Service Act on March 23, 2020. In this regard, FDA has announced a new rule that is expected to amend the regulations concerning the use of Drug Master Files (DMFs) for biologics. To support a Biologics License Application (BLA) submission, FDA allows to incorporate, by reference, the information contained in the DMFs. The DMFs provide information about facilities, processes, or articles used in the manufacturing, processing, packaging, or storage of a product while submitting to FDA.

If the new rule is implemented, all the biological products are expected to put in competition through the biosimilar pathway. The new rule is aimed at ensuring adequate product supplies and healthy competition in the market.  It also clarifies the use of information contained in DMFs for certain biologics, which are expected to undergo transition.

However, there are certain complications to adapt to the guideline. Out of many newly approved drug applications, few of them incorporate information related to the drug and its components in DMFs. Under the current practice, licensed biologics cannot obtain such information, as they do not have permissions to refer to the master files. Hence, FDA is advancing its policies and proposing this new rule to ensure seamless access to the data which might streamline the transition without affecting the manufacturers.

According to the proposed rule by the FDA, amending the existing regulations to use DMFs for biological products would:

  • Allow certain Biological License Applications (BLAs) approved under the Federal, Food, Drug, and Cosmetic Act to continue incorporating by reference information on Drug Substance (DS)/ Drug Substance Intermediates (DSI) or Drug Products (DP) contained in a DMF under the PHS Act
  • Reorganize the existing practice of the FDA so that except for information on DS/DSI, a BLA under the PHS Act may rely on the master file
  • Reorganize the existing practice of the FDA so that for a product subject to licensure under the PHS Act, information from a master file including DS/DSI/DP may be relied on at the investigational phase of development

So far, the FDA has identified that out of 89 products undergoing transition; approximately 17 of them currently incorporate, by reference, information on DS/DSI/DP in DMFs. Allowing the products to be transitioned to refer to the existing DMFs, manufacturers can save millions and can avoid new risks to the product safety, purity or potency.

As current regulations are rapidly being amended, it is necessary for Biologics manufacturers to continuously keep track of changing Regulatory scenarios. Therefore, it is necessary for the manufacturers to stay updated and evolve accordingly to be compliant throughout. Stay informed. Stay compliant. 


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