Hurst Photo /
8 August 2014Americas

FDA issues guidance on biologics’ exclusivity period

The US Food and Drug Administration (FDA) has issued guidance for biological drug makers about what information they should provide the agency to determine when their products’ marketing exclusivity period should begin, known as the “date of first licensure”.

This date will also determine when biosimilar versions of reference biologic products may be approved by the FDA.

Under Section 351(k)(7) of the Biologics Price Competition and Innovation (BPCI) Act of 2009, brought into force to speed up approvals for biosimilar products, biosimilars may be granted a licence by the FDA 12 years after the reference product’s date of first licensure.

Additionally, an application for approval for a biosimilar product cannot be submitted for review until four years after this date.

The guidance said that the determination of whether a particular biological product qualifies for a period of exclusivity can “present unique challenges”, because of the scientific and technical complexities associated with larger, more complex molecules, as well as the processes by which they are made.

It said that, in most instances, the date of first licensure will be the date the product was first licensed in the US.

However, there are exceptions. The date of first licensure will not include licensure for supplements for the biological product, or amended applications that include a new indication, route of administration, dosing schedule, or modification to the structure of the biological product that does not result in a change in safety, purity, or potency.

The guidance was issued days after five US senators wrote an open letter urging the FDA to issue guidance on naming conventions for biosimilar products under the BPCI Act.

The senators, who included Orrin Hatch, co-sponsor of the 1984 Hatch-Waxman Act that encouraged the manufacture and use of generic drugs, said that the guidance should be issued as soon as possible.

It noted the FDA’s acceptance of Sandoz’s biosimilar application in July, and asked: “Does the FDA intend to approve the first biosimilar before policies on these key scientific questions are publicly released?”

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at