Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 81

Another factor that may affect uptake of biosimilars is that a biosimilar generally cannot be automatically substituted for the reference product (i.e. brand‐name or innovator biologic) at the pharmacy level unless it is determined to be interchangeable with the reference product. An interchangeable product “can be expected to produce the same clinical result as the reference product in any given patient and, for a biological product that is administered more than once, that the risk of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of maintaining the patient on the reference product. Interchangeable products may be substituted for the reference product by a pharmacist without the intervention of the prescribing health care provider.” In January 2017, FDA released draft guidance on interchangeability, and final guidance on 10 May 2019. FDA has not yet approved an interchangeable biologic product.²³