학술논문

Biosimilar and interchangeable: Inseparable scientific concepts?
Document Type
Article
Source
British Journal of Clinical Pharmacology. Nov2019, Vol. 85 Issue 11, p2460-2463. 4p.
Subject
*DRUG prescribing
*GENERIC drug substitution
*BIOLOGICALS
*BIOSIMILARS
*PHYSICIANS
Language
ISSN
0306-5251
Abstract
Likely due to specific regulatory requirements in the United States, physicians sometimes interpret interchangeability as the potential for a biologic to be substituted by a biosimilar at the pharmacy level, without the involvement of a physician. However, interchangeability between a biological reference medicine and a corresponding biosimilar medicine should not be defined by its practical application; whether physician-driven switch or pharmacist-driven substitution. Despite the strength of the science supporting interchangeability, when two medicines are deemed to be interchangeable, physicians should be relevant players in any switching decision. A science-based understanding of interchangeability may raise confidence among physicians that currently prescribe biosimilars only in naïve patients, and may make them more comfortable switching from the reference medicine to a biosimilar, to further foster the positive impact of biosimilars. [Extracted from the article]