Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 188

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 188
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-year exclusivity period. If pediatric studies are performed and accepted by the FDA as responsive to a Written Request,
the 12-year exclusivity period will be extended for an additional six months. In addition, the FDA will not accept an application for
a biosimilar or interchangeable product based on the reference biological product until four years after the date of first licensure of
the reference product. “First licensure” typically means the initial date the particular product at issue was licensed in
the United States. Date of first licensure does not include the date of licensure of (and a new period of exclusivity is not available
for) a supplement for the reference product for a subsequent application filed by the same sponsor or manufacturer of the reference product
(or licensor, predecessor in interest or other related entity) for a change (not including a modification to the structure of the biological
product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or
strength or for a modification to the structure of the biological product that does not result in a change in safety, purity or potency.
Therefore, one must determine whether a new product includes a modification to the structure of a previously licensed product that results
in a change in safety, purity or potency to assess whether the licensure of the new product is a first licensure that triggers its own
period of exclusivity. Whether a subsequent application, if approved, warrants exclusivity as the “first licensure” of a biological
product is determined on a case-by-case basis with data submitted by the sponsor.

The BPCIA is complex and is
still being interpreted and implemented by the FDA. In addition, recent government proposals have sought to reduce the 12-year reference
product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the
subject of litigation. As a result, the ultimate impact, implementation and meaning of the BPCIA is subject to significant uncertainty.

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Pediatric Studies and Exclusivity

Under the Pediatric Research
Equity Act, or PREA, amendments to the FDCA, an NDA, BLA or supplement thereto must contain data that are adequate to assess the safety
and effectiveness of the drug product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and
administration for each pediatric subpopulation for which the product is safe and effective. With enactment of