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BNT162b2
1.3. Administrative Information
CONFIDENTIAL
Page 1of 21.3.5.3 EXCLUSIVITY REQUEST
The Sponsor included a claim forreference product exclusivity under section 351(k)(7) of the
Public Health Service Act (PHSA) in the original BLA 125742 for COMIRNATY (COVID-19
Vaccine, mRNA) .
The Sponsor requests that the FDA applythereference product exclusivity that was claimed in
connection with the first licensure of COMIRNATY to the changes proposed in the
COMI RNATY supplemental BLA, which seeks approval of labeling changes related to the
administration of COMIRNATY to a new patient population of individuals of 12 y ears of age
and older (i.e. changed from 16 y ears of age and older). This request for FDA’s application of
“umbrella exclusivity ” in connection with reference product exclusivity is supported b y the
statute, FDA’s draft guidance on reference product exclusivity , and an Agency precedent .
The applicable statute provides that r eference pro duct exclusivity starts on the “date on which the
reference product was first licensed under subsection (a )” of PHSA section 351 and indicates that
the date of approval of a supplemental BLA is not a new date of first licensure .1
In the draft guidanc e, FDA has suggested that a supplemental BLA that is ineligible for its own
period of reference product exclusivity nonetheless may be eligible for umbrella exclusivity . For
example, FDA has stated that “[a] biological product submitted for licensure unde r section
351(a) of the PHS Act (a 351(a) application) may be eligible for a period of exclusivity that
commences on the date of its licensure unless its date of licensure is not considered a date of first
licensure because it falls within an exclusion under 351(k)(7)(C).” This sentence suggests that a
supplemental BLA (which falls within the referenced exclusion) would remain eligible for
reference product exclusivity , although the exclusivity period would commence on the date of
first licensure ( in gener al, the date of approval of the original BLA) rather than on the approval
date of the supplement.2
Finally , a precedent inthe Purple Book database indicate sthat the FDA is apply ing umbrella
exclusivity to supplemental BLAs. The Purple Book reflects that both the original BLA 125285
for FLUBLOK (influenza vaccine) (approved on January 16, 2013) and a supplement to that
BLA ( approved on October 7, 2016) share the same first licensure date of January 16, 2013, the
approval date of the original BLA . The Purple Book further reflects that reference product
exclusivity expires on January 16, 2025 for both the original BLA and the supplement.
Similarly , the reference product exclusivity that earned in connection with the approval of the
original BLA for COM IRNATY should cover the COMI RNATY supplement al BLA .
The Sponsor therefore requests that FDA appl y umbrella exclusivity to this supplemental BLA
for COMI RNATY . Accordingl y, FDA should not approve an y biosimilar application
1PHSA § 351(k)(7).
2FDA, Draft Guidance for Industry ,Reference Product Exclusivity for Biological Products Filed Under Section
351(a) of the PHS Act (Aug. 2014) , at 3 -5(noting that when a product’s licensure date is not considered the date of
first licensure, that product does not receive a “ne w period of exclusivity,” a “separate period” of exclusivity, or “its
own period of exclusivity”).
090177e198ceaaf3\Final\Final On: 08-Dec-2021 03:28 (GMT)
FDA-CBER-2022-5812-0220464
BNT162b2
1.3. Administrative Information
CONFIDENTIAL
Page 2of 2referencing BLA 125742 , and seeki ng approval for the changes proposed in this supplemental
BLA, until 12 years after COMI RNATY’s first licensure date .
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FDA-CBER-2022-5812-0220465