FDA Hopes to Accelerate Biosimilar Supplement Reviews

February 7, 2020

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.

On February 6, the US FDA published a new draft guidance entitled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLA before a certain date.

“As part of its review, FDA assesses the manufacturing process and the manufacturer’s strategy to control within-product variations. These control strategies are put in place to help ensure that manufacturers produce biological products with consistent clinical performance,” the FDA states.

The draft provides recommendations to applicants who are seeking licenses for a proposed biosimilar or interchangeable application supplements, with the aim of expediting reviews for biosimilars supplements. It can also be used to update initial biosimilar approvals when it is for fewer than all the reference product’s approved conditions.

According to the guidance, biosimilars or interchangeable products cannot be licensed for an indication by the FDA if they are protected by orphan drug exclusivity or pediatric exclusivity, until that exclusivity expires. Applicants can submit a supplement to the licensed 351(k) BLA for the previously protected indication once any exclusivity or patent expires.

The FDA recommends that when possible, an applicant who is seeking licensure for a proposed interchangeable product also seek licensure for all of the reference product’s licensed conditions of use.

Proposed biosimilar labeling will be dependent on whether the applicant seeks licensure for all or fewer of the conditions of use licensed for the reference product, according to RAPS.

Electronic or written comments on the draft can be submitted until April 7, 2020, before the final version of the guidance is released.


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