On February 6, 2020, FDA issued draft guidance on Biosimilars and Interchangeable Biosimilars: Licensure for Fewer than All Conditions of Use for Which the Reference Product Has Been Licensed. The draft guidance provides recommendations on submission of an application for licensure under 351(k) for a biosimilar or interchangeable biosimilar or supplement to a licensed 351(k) BLA application for fewer than all of the reference product’s licensed conditions of use, development of proposed labeling when such approval is sought, and timing for the submission with the goal of obtaining licensure of a condition of use as soon as possible after the expiration of any relevant exclusivity or patents.
In this guidance, FDA makes clear that a biosimilar or interchangeable biosimilar may be licensed only for conditions of use that have been previously licensed for the reference product. And while an applicant generally may obtain licensure for fewer than all of the conditions, FDA recommends that an applicant seeking licensure for a proposed interchangeable product seek licensure for all of the reference product’s licensed conditions of use when possible.
FDA provides orphan-drug exclusivity (ODE) and patents as two circumstances that may lead an applicant to seek licensure for fewer than all of the conditions of use for which the reference product is licensed. With regard to ODE, the guidance states that FDA will not be able to license a biosimilar or interchangeable product for protected indications until the applicable exclusivity expires. Thus, an applicant may seek licensure for one or more indications of the reference product that are not protected and later may, in a supplement to the licensed 351(k) BLA, seek licensure of the previously protected indication. The guidance also recognizes that an applicant may decide not to seek licensure for conditions of use that, according to applicant’s own assessment, are protected by patent rights.
FDA also explains applicants should develop draft labeling that includes information from the reference product’s labeling that is relevant to the proposed conditions of use for the proposed biosimilar or interchangeable. In preparing the draft label, the applicant must ensure that relevant information from all sections of the labeling is included, based on the proposed conditions of use. The labeling must also summarize the essential scientific information needed for the safe and effective use of the product. An applicant need not submit a justification for the applicant’s decision not to seek licensure of a biosimilar for all of the reference product’s licensed conditions of use but is free to do so.
FDA reiterates that it is committed to reviewing and acting on original 351(k) BLAs and original 351(k) BLA supplements with clinical data within 10 months of the 60-day filing date or receipt date, respectively. But to the extent practicable, supplements to 351(k) BLAs that do not raise novel issues will be reviewed and acted upon within 6 months. If, however, an applicant desires FDA to act only after a specified date, the applicant can request FDA to refrain from action before that date, provided the date does not extend beyond an applicable Biosimilar User Fee Act goal date.
Comments to this draft guidance should be submitted to FDA by April 6, 2020.
Readers are encouraged to read the draft guidance, also available on FDA's website.
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