FDA Issues New Biosimilars Draft Guidance Providing Increased Exclusivity Rights

By Cyndi Root

The Food and Drug Administration (FDA) announced in the Federal Register that it has issued a new biosimilars draft guidance. The draft guidance assists biologics sponsors in submitting information that helps the FDA to determine the first licensing date of a reference product under the Public Health Service Act (PHS Act). The guidance titled, ‘‘Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act,” informs sponsors that the FDA intends to interpret the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) in relation to the PHS ACT regarding biologics exclusivity. The guidance is a call to action for past, present, and future BLA sponsors to submit more information so that the agency may consider the reference product for exclusivity.

The FDA Law Blog states, “That’s a burden that sponsors will likely gladly bear, because FDA’s proposed broad interpretation of structural modification, a key term in determining whether a related product differs enough from a sponsor’s structurally related product to merit its own exclusivity, makes more products eligible for exclusivity.”

Biosimilar Structural Modification

On Page 5 of the Draft Guidance, the FDA explains its interpretation of structural modification. The agency states that the date of the first licensure excludes approvals for new indications, routes of administration, dosing schedules, dosage forms, delivery systems, delivery devices, or strength unless the biological structure is modified. Additionally, the exception holds if the modification causes a change in safety, purity, or potency.

Therefore, the FDA says that it is “essential to first determine whether a new product includes a modification to the structure of a previously licensed product to assess whether the licensure of the new product is a first licensure that triggers its own period of exclusivity.” Sponsors seeking exclusivity now have a roadmap to help the FDA determine exclusivity. The agency states that sponsors should describe the difference between its product and any previously licensed biological product including amino acid sequence, glycosylation patterns, tertiary structures, post-translational events, pegylation, and infidelity of translation or transcription.

The FDA will assess changes in safety, purity, or potency on a case-by-case basis, depending on the sponsor’s data. Information should include preclinical and clinical data, measurable effects, and bioassays. Additionally, the FDA will consider evidence that the product offers a benefit, a therapeutic advantage, or a meaningful benefit to public health compared to a previously licensed biological product.