As part of its ongoing efforts to encourage biosimilars, the FDA issued draft guidance on the agency’s abbreviated review pathway for sponsors of biosimilars with more limited conditions of use than the reference product.
The 351(k) abbreviated licensing pathway is designed to speed biosimilar approvals by using “less than a full complement of product-specific preclinical and clinical data,” the agency noted.
In general, drugmakers don’t need to wait for a drug’s patent or exclusivity to expire to submit a 351(k) BLA application. But they may not license products for indications protected by orphan drug or pediatric exclusivity, the agency said.
Submissions should include draft labeling that lists the conditions of use being applied for, and information from the reference product’s labeling on the proposed conditions of use, along with “appropriate modifications.”