Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 189

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 189
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 in any given patient and, for products administered multiple times to an individual, that the product and the
reference product may be alternated or switched after one has been previously administered without increasing safety risks or risks of
diminished efficacy relative to exclusive use of the reference biological product without such alternation or switch. Upon licensure by
the FDA, an interchangeable biosimilar may be substituted for the reference product without the intervention of the healthcare provider
who prescribed the reference product.

The biosimilar applicant must
demonstrate that the product is biosimilar based on data from (1) analytical studies showing that the biosimilar product is highly
similar to the reference product; (2) animal studies (including toxicity); and (3) one or more clinical studies to demonstrate
safety, purity and potency in one or more appropriate conditions of use for which the reference product is approved. In addition, the
applicant must show that the biosimilar and reference products have the same mechanism of action for the conditions of use on the label,
route of administration, dosage and strength, and the production facility must meet standards designed to assure product safety, purity
and potency.

A reference biological product
is granted 12 years of data exclusivity from the time of first licensure of the product, and the first approved interchangeable biologic
product will be granted an exclusivity period of up to one year after it is first commercially marketed. As part of the Consolidated Appropriations
Act for 2023, Congress amended the PHSA in order to permit multiple interchangeable products approved on the same day to receive and benefit
from this one-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