On August 4, 2014, the US Food and Drug Administration (FDA)
released Draft Guidance on determining eligibility of a
biological drug for regulatory exclusivity.
Under the Public Health Service Act (PHS Act), as amended in 2010,
an abbreviated biosimilar application can be accepted by the FDA,
but not until 4 years after the first licensure of the original
reference product and, once accepted, such an application cannot be
fully approved by the FDA for a period of 12 years from the
reference's first licensure. This reference product exclusivity
is granted independently of any patent exclusivity, and therefore,
by itself, provides a significant incentive to the sponsor of a
Biologic License Application (BLA) who obtains the first licensure
status. The date of first licensure is also critical to the timing
of a follow-on biosimilar entry to the market.
Sponsors of the original BLAs generally have superior information
about their products, and therefore, could gain an unfair advantage
from evergreening BLAs based upon minor product improvements, each
with 12 years of additional exclusivity. However, not every BLA
triggers an exclusivity period. Specifically, under section
351(k)(7)(C) of the PHS Act, a new period of exclusivity is not
available to the same sponsor or an affiliated party if the same
product is licensed for a new indication, route of administration,
dosing schedule, dosage form, delivery system, delivery device, or
strength. Additionally, a structurally modified product is not
eligible for a new period of exclusivity if such structural
modification does not result in improved safety, purity, or
potency.
The Draft Guidance provides the agency's interpretation of the
following key provisions in Section 351(k)(7)(C):
- who is considered an affiliated entity (as in "licensor, predecessor in interest, or other related entity");
- what is meant by "modification to the structure"; and
- how BLA applicants can demonstrate to the FDA that a structural change indeed results in "a change in safety, purity, or potency."
The Draft Guidance will be of particular interest to BLA
sponsors who are aiming at extending market exclusivity by
developing second generation, improved biologics, also known as
"biobetters." Additionally, the Draft Guidance may impact
BLA sponsors who have multiple related products in development, for
example, multiple antibodies against the same target. In many
situations, the availability of regulatory exclusivity, or lack
thereof, will have an impact on patent strategy and, ultimately, on
the valuation of a drug or drug candidate.
All comments on the Draft Guidance should be submitted to the FDA
within 60 days from publication in the Federal Register, i.e., by
October 6, 2014.
Please contact your Nutter attorney if you are interested in
learning more about the topic or submitting comments.
This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.