US FDA tweaks requirements for 12-year biologics exclusivity

By Fiona BARRY

- Last updated on GMT

Spot the difference: biologics makers must show why their product is unique. (Picture credit: Flickr/Heather Katsoulis)
Spot the difference: biologics makers must show why their product is unique. (Picture credit: Flickr/Heather Katsoulis)

Related tags Protein Amino acid

The US Food and Drug Administration (FDA) has issued guidance on biologics exclusivity, stipulating the evidence drugmakers must provide to ensure a 12-year exclusivity period.

The document, Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act,​ supplements existing rules in the Biologics Price Competition and Innovation Act (BPCI) which grant new biologics 12 years’ marketing exclusivity, during which rivals may not launch biosimilars. The FDA will not accept biosimilars filings (under its 351(k) pathway) until five years after the original biologic is licensed.

Your time starts now…

The FDA’s latest guidance clarifies the date it deems the 12-year exclusivity to begin, known as “first licensure​” under Section 351(k)(7)(C) of the Public Health Service Act. Updated guidance states, “In most instances, the date of first licensure will be the initial date the particular product at issue was licensed in the United States​.”

However, the FDA says this is not the case when this launch date “is not considered a data of first licensure​” because it falls under a number of exceptions.

The FDA will not grant 12-year exclusivity to manufacturers who submit altered versions of their already-marketed biologics with a new “indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength.​”

An exception is modifications to “the structure of the biological product,​” which “result in a change in safety, purity or potency.​”

Spot the difference

Biotechs seeking 12-year marketing exclusivity on updated versions of their biologics will have to describe to the FDA the “structural differences”​ between their product and any licensed biopharmaceuticals “structurally related”​ to it, including those which target different epitopes of the same molecular target.

These differences will include changes in amino acid sequence, post-translational events, infidelity of translation or transcription, glycosylation patterns or tertiary structure, and differences in biological activities.

Submissions should also include evidence of changes in safety, purity, or potency between the new biologic and existing related ones.

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