Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 188

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 188
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 or 505(b)(2) application.

| 93 |

A certification that the new
product will not infringe the already approved product’s listed patents or that such patents are invalid or unenforceable is called
a Paragraph IV certification. If the follow-on applicant has provided a Paragraph IV certification to the FDA, the applicant must also
send notice of the Paragraph IV certification to the NDA and patent holders once the follow-on application in question has been accepted
for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph
IV certification. The filing of a patent infringement lawsuit within 45 days after the receipt of a Paragraph IV certification automatically
prevents the FDA from approving the ANDA or 505(b)(2) NDA until the earlier of 30 months after the receipt of the Paragraph IV notice,
expiration of the patent or a decision in the infringement case that is favorable to the ANDA or 505(b)(2) applicant. Alternatively, if
the listed patent holder does not file a patent infringement lawsuit within the required 45-day period, the follow-on applicant’s
ANDA or 505(b)(2) NDA will not be subject to the 30-month stay.

Reference Product Exclusivity for Biological Products

In March 2010, the Patient
Protection and Affordable Care Act, or ACA, was enacted in the United States and included the Biologics Price Competition and Innovation
Act of 2009, or the BPCIA. The BPCIA amended the PHSA to create an 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