In late 2020, the United States Food and Drug Administration (FDA) issued a draft set of four questions and answers guidance that provides insight into how it plans to handle certain aspects of submissions and labeling for interchangeable products, including biosimilars.
The first question covers how an applicant can seek FDA review for licensure of an interchangeable biosimilar and from there, how does the FDA intend to review an application that is submitted under Section 351(k) that includes data and information sufficient to support licensure as a biosimilar product but not sufficient to support licensure as an interchangeable biosimilar. In its response, the FDA notes that there may be situations in which the data and information provided in a BLA seeking licensure as an interchangeable biosimilar can support licensure of the product as a biosimilar product but not as an interchangeable biosimilar. The draft guidance goes on to discuss that particular situation and what the FDA does in response.
The second question covers how a 351(a) BLA holder should proceed if it wishes to seek licensure of its biological product under section 351(k) as a biosimilar to or interchangeable with another reference product. In its response, which goes into more detail than this brief article, the FDA noted that in this instance, the holder should submit an original application for licensure under section 351(k). The application should specify the single biological product licensed or deemed licensed under section 351(a) of the PHS Act as the reference product, as that term is defined in section 351(i), against which the proposed biosimilar or proposed interchangeable product will be evaluated, and include additional pertinent information.
The third question covers whether the FDA has recommendations for labeling of interchangeable biosimilars at this time. In response, the FDA noted that there are certain principles outlined in the Labeling for Biosimilar Products (July 2018) guidance that apply to interchangeable biosimilars, such as that the biosimilar product labeling incorporate relevant data and information from the reference product labeling with appropriate modifications.
The fourth and final question covers whether the FDA recommends that the BLA-holder of an approved interchangeable biosimilar include a labeling statement on interchangeability. In its draft response, the FDA does indicate that it has recommendations, including placing a statement on the line immediately beneath the Initial U.S. Approval in the Highlights of Prescribing Information that the product is interchangeable with the reference product. The response also includes specific language the FDA recommends including in that statement.
FDA is currently accepting comments through January 19, 2021. While the agency notes that you can submit comments on guidance at any time, if you want to be sure the FDA considers your comment on a draft guidance before implementing the final guidance, you need to submit your comment prior to January 19, 2021.
After the close of the comment period, FDA will add the final version of these questions and answers to the current final questions and answers guidance on biosimilar development.