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FDA Targets Faster Reviews for Biosimilar Supplements, Draft Guidance Says

Posted 06 February 2020 | By Zachary Brennan 

FDA Targets Faster Reviews for Biosimilar Supplements, Draft Guidance Says

The US Food and Drug Administration (FDA) on Thursday published new draft guidance explaining how it will speed its review of biosimilar or interchangeable application supplements, which can be used to update the initial biosimilar approval when it is for fewer than all the reference product’s licensed conditions of use.

The 9-page draft details how FDA cannot license a biosimilar or interchangeable product for an indication protected by orphan-drug exclusivity or pediatric exclusivity until the expiration of that exclusivity. Applicants also may decide not to seek licensure of a proposed biosimilar or proposed interchangeable product for conditions of use that are protected by a patent or for other reasons.

For instance, when Pfizer’s Inflectra (infliximab-dyyb) and Merck’s Renflexis (infliximab-abda) were first approved, FDA approved them for all the same indications as J&J’s Remicade (infliximab), except pediatric ulcerative colitis. This indication was excluded because J&J at the time enjoyed an FDA-granted period of orphan exclusivity. Similarly, when Amgen won approval for its Humira (adalimumab) biosimilar Amjevita (adalimumab-atto), the company did not seek approval for several indications because of orphan exclusivity.

But after that exclusivity or patent expires, an applicant may decide to submit a supplement to the licensed 351(k) biologics license application (BLA) for the previously protected indication.

And although FDA committed to reviewing and acting on original 351(k) BLA supplements with clinical data within 10 months of receipt, the agency now says such supplements will be reviewed and acted upon in a 6-month timeframe.

“As noted, the BsUFA II Goals Letter describes a 10-month goal date for original 351(k) BLA supplements with clinical data. However, at this time, FDA believes that a review timeframe of 6 months will generally be appropriate for a supplement to a licensed 351(k) BLA seeking licensure of the biosimilar or interchangeable product for an additional condition of use that has been previously licensed for the reference product, assuming the supplement does not raise novel review issues,” the draft says.

If an applicant does not want FDA to take action on a 351(k) BLA or supplement before a specified date, the applicant should request that FDA refrain from acting on the application, the draft adds.

To make such a request, the draft says that an applicant should include the following language on the cover letter of their BLA or supplement, in bold typeface and prominently placed above the body of the cover letter:
“351(k) BLA action timing request: [Applicant Name] requests that FDA not take action on this [application/supplement] before [specified date].”

The draft also explains how the proposed labeling for a biosimilar will depend on whether the applicant is seeking licensure for all (or fewer) of the conditions of use licensed for the reference product. And an applicant may submit a justification as to why, in the applicant’s view, the draft labeling meets the requirements for approval, considering the conditions of use for which the applicant is seeking licensure.

FDA also says that it 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.

Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry


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