Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 141

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 141
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conciliation Act of 2010 (collectively, the “Affordable Care Act”), created an abbreviated
approval pathway for biological products that are demonstrated to be “biosimilar” or “interchangeable” with an
FDA-licensed reference biological product via an approved BLA. Biosimilarity to an approved reference product requires that there be no
differences in conditions of use, route of administration, dosage form, and strength, and no clinically meaningful differences between
the biological product and the reference product in terms of safety, purity, and potency. Biosimilarity is demonstrated in steps beginning
with rigorous analytical studies or “fingerprinting”, in vitro studies, in vivo animal studies, and generally at least one
clinical study. If at any point in the stepwise biosimilarity process a significant difference is observed, then the products are not
biosimilar, and the development of a standalone BLA is necessary. In order to meet the higher hurdle of interchangeability, a sponsor
must demonstrate that the biosimilar product can be expected to produce the same clinical result as the reference product, and for a product
that is administered more than once, that the risk of switching between the reference product and biosimilar product is not greater than
the risk of maintaining the patient on the reference product. Complexities associated with the larger, and often more complex, structures
of biological products, as well as the process by which such products are manufactured, pose significant hurdles to implementation that
are still being evaluated by the FDA. Under the BPCIA, a reference biologic is granted 12 years of exclusivity from the time of first
licensure of the reference product.

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Regulation Outside of the United States

In addition to regulations
in the United States, we are subject to a variety of regulations in other jurisdictions governing clinical studies, commercial sales,
and distribution of our products. Most countries outside of the United States require that clinical trial authorization applications be
submitted to and approved by the local regulatory authority for each clinical study. In the European Union, for example, an application
must be submitted to the national competent authority and an independent ethics committee in each country in which we intend to conduct
clinical trials, much like the FDA and IRB, respectively. Under the Clinical Trials Regulation (EU) No 536/2014, which replaced the Clinical
Trials Directive 2001/20/EC on January 31, 2022, a single application is now made through the Clinical Trials Information System for clinical