Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 187

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 187
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 in demand for any such product candidates.

Our product candidates for which we intend
to seek approval as biological products may face competition sooner than anticipated, including from other therapeutic modalities.

The Affordable Care Act,
signed into law on March 23, 2010, includes a subtitle called the BPCIA, which created an abbreviated approval pathway for biological
products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application
for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed
by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which
the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version
of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data
and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product.

We believe that any of our
product candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity. However, there is
a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product
candidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated.
Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation.
Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our products in a way that is similar to
traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory
factors that are still developing.

If any approved products
are subject to biosimilar competition sooner than we expect, we will face significant pricing pressure and our commercial opportunity
will be limited.

The insurance coverage and reimbursement
status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new products could
limit our product revenues.

Our ability to commercialize
any of our product candidates successfully will depend in part on the extent to which reimbursement for these products and related treatments
will be available from government health administration authorities, private health insurers, and other organizations. In the United