Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 38

In July 2018, the USFDA published its Biosimilars Action Plan, BAP.⁶⁶ Key elements of the BAP include (i) improving the efficiency of the biosimilar and interchangeable product development and approval process; (ii) maximizing scientific and regulatory clarity for the biosimilar product development community; (iii) developing effective communication to improve understanding of biosimilars among patients, clinicians, and payers; and (iv) supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay biosimilar competition.