The US Food and Drug Administration (FDA) on Thursday published new draft guidance explaining how it will speed its review of biosimilar or interchangeable application supplements, which can be used to update the initial biosimilar approval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…