Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 212

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 212
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 Equivalent Samples Act of 2019, or the CREATES Act. The CREATES Act aims
to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted
the distribution of their products, including by invoking the existence of a REMS for certain products, to deny generic and biosimilar
product developers access to samples of brand products. Because generic and biosimilar product developers need samples to conduct certain
comparative testing required by the FDA, some have attributed the inability to timely obtain samples as a cause of delay in the entry
of generic and biosimilar products. To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic
or biosimilar product developer to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable,
market-based terms.” Whether and how generic and biosimilar product developments will use this new pathway, as well as the likely
outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on our future commercial
products are unknown.

More recently, in August 2022,
President Biden signed into the law the Inflation Reduction Act of 2022, or the IRA. Among other things, the IRA has multiple provisions
that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. Starting in
2023, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the
drug product’s price increases faster than the rate of inflation. This calculation is made on a drug product by drug product basis
and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by
Medicare Parts B or D. Additionally, starting in payment year 2026, CMS will negotiate drug prices annually for a select number of single-source
Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting
for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug
will decrease. CMS has begun to implement these new authorities and entered into the first set of agreements with pharmaceutical manufacturers
to conduct price negotiations in October 2023. However, the IRA’s impact on the pharmaceutical industry in the United States remains
uncertain, in part because multiple large pharmaceutical companies