FDA drafts guidance on classification category for biosimilar supplements

The US Food and Drug Administration (FDA) just published draft guidance to assist sponsors determine the appropriate supplement category for biosimilar applications and its goals for reviewing them. The guidance also describes the process for submitting supplements.
 
FDA states that “these supplement categories will help to ensure consistent processes for reviewing these supplements across review divisions.”
 
The guidance covers the six classification categories for supplements and their associated review performance goals that were established under the Biosimilar User Fee Amendments of 2022 (BsUFA III) commitment letter, released in September 2021. (RELATED: BsUFA III commitment letter details FDA, industry goals for biosimilars program, Regulatory Focus 21 September 2021)
 
The guidance states that “in previous authorizations of BsUFA, FDA’s review performance goals did not include commitments specifically related to various types of labeling changes.” The agency also states that it “is committed to continuing to ensure effective scientific coordination and review consistency, as well as efficient governance and operations across the biosimilar product review program.”
 
FDA’s review goals will vary depending on the type of supplements. For example, supplements seeking a straightforward safety update will be reviewed in a shorter timeframe than those adding new efficacy data.
 
Categories described
 
FDA said Category A supplements are for “straightforward changes incorporating safety labeling updates” for biosimilars or interchangeable biosimilar products. This labeling “should incorporate relevant and information from the reference product labeling, with appropriate modifications. When new information becomes available that causes information in labeling to be inaccurate, false, or misleading, the application holder must take steps to change the content of its product labeling, in accordance with 21 CFR 601.12.”
 
Category B is for those supplements seeking additional indications and involve the submission of analytical in vitro data collected through physical, chemical or biological assays. Supplements in this category should not seek a new route of administration, dosage form, dosage strength, formulation, or presentation.
 
Supplements in this category should include an up-to-date agreed initial pediatric study plan (iPSP) if the supplement is subject to section 505B(a) which amends the FD&C Act to set forth new requirements on pediatric drug development under the FDA Reauthorization Act of 2017 (FDARA).
 
Category C supplements are for those that remove indications; in this category, applicants must provide information necessary to support the labeling change.
 
Category D is for supplements seeking to add an indication to a licensed biosimilar or interchangeable biosimilar product. This category is reserved for the submission of new data sets “other than efficacy data.” Such data can include analytical in vitro data obtained by physical, chemical, or biological function assays,” FDA writes.
 
Category E is for sponsors seeking approval of an additional indication that involves the filing of efficacy data.
 
Category F is reserved for BLA supplements that seek an initial determination of interchangeability. FDA states that “Category F supplements may include, for example, a clinical study report for a switching study or a scientific justification for not needing such data as part of the demonstration of interchangeability in the submission.”
 
Review timeframes
 
Supplements for safety labeling changes would be reviewed in a shorter time frame than those that involve the submission of new efficacy data.
 
Under the BSUFA III performance goals, Category A submissions will be reviewed within three months of submission, Category B and Category C within four months, Category D within six months, and Category E and Category F within ten months for initial submissions. The resubmission timelines are the same as the initial timeline for all categories, except for Category E and F, which should be acted on within 6 months.
 
In the cover letter, applicants should “clearly and briefly state the basis for the proposed supplement category in the supplement submission.” They should also describe the proposed labeling changes and include the necessary information to support the proposed changes.
 
The public has 60 days to comment on the guidance.
 
Guidance