Earlier this month, the United States Food and Drug Administration (FDA) issued new draft guidance on how it plans to expedite its review of biosimilar or interchangeable application supplements.
The draft guidance provides recommendations to applicants seeking of a proposed biosimilar or proposed interchangeable biosimilar licensure under section 351(k) of the Public Health Service Act for less than all of the reference product’s licensed conditions of use. Applicants may occasionally opt not to seek licensure of a proposed biosimilar or interchangeable product for conditions of use that are under patient protection, or for other reasons. By way of example, FDA initially approved Pfizer’s Inflectra and Merck’s Renflexis for the same indications as Johnson & Johnson’s Remicade, except for pediatric ulcerative colitis, an indication for which J&J had orphan exclusivity.
The guidance also provides recommendations on the submission of a supplement to a licensed 351(k) biologics license application (BLA) that seeks to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product.
For biosimilars, once the exclusivity or patent expires, the applicant can submit a supplement to the licensed 351(k) biologics license application for the previously protected indication. The Agency provided an updated time frame for review, expecting that supplements will now be reviewed and acted upon within a 6-month timeframe. However, if for some reason an applicant does not want the FDA to take action within that 6-month timeframe, it can request that the FDA refrain from taking any action on the application by including the following language on the cover letter of the biologics license application 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 guidance further explained that the proposed labeling for a biosimilar will depend on whether the applicant is seeking licensure for all of the conditions of use licensed for the reference product, or just some of them. The applicant can also submit its own justification for why it believes the draft labeling meets the requirements for approval, considering the conditions of use for which the applicant is seeking licensure.
FDA also noted in the guidance that an applicant seeking licensure for a proposed interchangeable product should seek licensure for all of the reference product’s licensed conditions of use when possible.
If you are interested, you can submit comments on this draft guidance by April 7, 2020 for consideration by the Agency as it works on the final version of the guidance.