Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 195

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 195
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 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.

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 applications be submitted
to and approved by the local regulatory authority for each clinical study. In the European Union (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 trial authorization in up to 30 EU/EEA countries at the same time and with a single
set of documentation.

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The assessment of applications
for clinical trials is divided into two parts (Part I contains scientific and medicinal product documentation and Part II contains
the national and patient-level documentation). Part I is assessed by a coordinated review by the competent authorities of all European
Union member states (the “Member States”) in which an application for authorization of a clinical trial has been submitted
(Member States concerned) of a draft report prepared by a reference Member State. Part II is assessed separately by each Member
State concerned. The role of the relevant ethics committees in the assessment procedure continues to be governed by the national law
of the Member State concerned, however overall related timelines are defined by the Clinical Trials Regulation. The Clinical Trials Regulation