Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 26

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 26
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 written request from the FDA. The issuance of a written request does not require the sponsor
to undertake the described clinical trials.

Biosimilars
and Reference Product Exclusivity

The
Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated approval pathway for biological products that
are highly similar, or “biosimilar,” to or interchangeable with an FDA-approved reference biological product. The FDA has
issued several guidance documents outlining an approach to review and approval of biosimilars. Biosimilarity, which requires that there
be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency,
is generally shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product
is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results
as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and
the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks
of diminished efficacy relative to exclusive use of the reference biologic. A product shown to be biosimilar or interchangeable with
an FDA-approved reference biological product may rely in part on the FDA’s previous determination of safety and effectiveness for
the reference product for approval, which can potentially reduce the cost and time required to obtain approval to market the 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 that applicant’s
own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its
product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it
is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which
are governed by state pharmacy law.

21

A