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Interchangeability is defined as the medical practice of changing one medicine for another to achieve the same clinical effect in a given clinical setting and patient, on the initiative of, or with the prescriber's agreement. An interchangeable product is a biosimilar that produces the same clinical outcome in any given patient. Demonstration of interchangeability presents many challenges.³²

In the United States, registration of a biosimilar does not imply interchangeability and another class of biosimilars, “interchangeable biosimilars” have been introduced into the regulatory framework. To meet this interchangeability designation, a sponsor must demonstrate that the biosimilar produces 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 switching between the biosimilar and reference product is not greater than the risk of maintaining the patient on the reference product. No biosimilar has been granted interchangeability status so far.