Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2138

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2138
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testing. Biosimilarity, which requires that the biological product be highly similar to the reference product notwithstanding minor differences
in clinically inactive components and that there be no clinically meaningful differences between the product and the reference product
in terms of safety, purity and potency, can be shown through analytical studies, animal studies and a clinical trial or trials. Interchangeability
requires that a biological product be biosimilar to the reference product and that the product can be expected to produce the same clinical
results as the reference product in any given patient and, for products administered multiple times to an individual, that the product
and the reference product 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 biological product without such alternation or switch. Complexities
associated with the larger, and often more complex, structure of biological products as compared to small molecule drugs, as well as
the processes by which such products are manufactured, pose significant hurdles to implementation that are still being worked out by
the FDA.

55

A
reference biological product is granted four and twelve year exclusivity periods from the time of first licensure of the product. FDA
will not accept an application for a biosimilar or interchangeable product based on the reference biological product until four years
after the date of first licensure of the reference product, and FDA will not approve an application for a biosimilar or interchangeable
product based on the reference biological product until twelve years after the date of first licensure of the reference product. “First
licensure” typically means the initial date the particular product at issue was licensed in the United States. Date of first licensure
does not include the date of licensure of (and a new period of exclusivity is not available for) a biological product if the licensure
is for a supplement for the biological product or for a subsequent application by the same sponsor or manufacturer of the biological
product (or licensor, predecessor in interest, or other related entity) for a change (not including a modification to the structure of
the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery
device or strength, or for a modification to the structure of the biological product that does not result in a change in safety, purity,
or potency. Therefore, one must determine whether a new product includes a modification to the structure of a previously licensed product
that results in a change in safety