Biosimilars & Pharmaceuticals

Interchangeable Biologic/Biosimilars

An “interchangeable” biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient. To be approved as interchangeable, research must show that the biosimilar drug produces the exact same results in an individual patient, that a person can take either drug and expect the same symptom reduction and same side effects. To date, no biosimilars have been approved as interchangeable.

Interchange ability standards:

1. The biological product is biosimilar to the reference product;

2. It can be expected to produce the same clinical result as the reference product in any given patient; and

3. For a product that is administered more than once to an individual, the risk in terms of safety or diminished    efficacy of alternating or switching between use of the product and the reference product is not greater than the risk of using the reference product without such alternation or switch.