Setting a Higher Bar for Interchangeability
Custom Synthesis, Clinicians will also need to be educated about the idea of interchangeability, Dr. Hurvitz continued. An interchangeable product is a biosimilar product that may be substituted for the reference product without involving the health care provider who prescribed the drug.
Additional evidence is required from manufacturers for a biosimilar product to receive designation as an interchangeable product. For instance, manufacturers need to show that a biosimilar product is expected to produce the same clinical result as the reference product in any given patient.
And for a product that is administered more than once to an individual, manufacturers must show that switching between the proposed interchangeable drug and the reference product does not pose safety risks or compromise effectiveness.
FDA’s high standards for approval of interchangeable products are intended to assure patients and health care providers that they can have confidence in the safety and effectiveness of an interchangeable product, just as they would for an FDA-approved reference product, Dr. Hurvitz noted.
No biosimilar has yet been approved as an interchangeable product, she added.http://www.haihengpharma.com/setting-a-higher-bar-for-interchangeability/News