Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 187

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 187
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 abbreviated approval pathway for biological products that are biosimilar
to or interchangeable with an FDA-licensed reference biological product. To date, the FDA has approved a number of biosimilars, and numerous
biosimilars have been approved in Europe. The FDA has also issued several guidance documents outlining its approach to reviewing and approving
biosimilars and interchangeable biosimilars, and has created a public database that contains information on all FDA-licensed biological
products, including biosimilars, called the Purple Book.

A biosimilar product is defined
as one that is highly similar to a reference product notwithstanding minor differences in clinically inactive components and for which
there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity
and potency of the product. An interchangeable product is a biosimilar product that can be expected to produce the same clinical results
as the reference product 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