Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 33

1.8 Listing of Approved Biologics 1.8.1 Purple Book in the United States

Оглавление

The Purple Book is a compendium of FDA‐approved biological products and their biosimilar and interchangeable products. It resembles the Orange Book, which is a list of approved SMD generics. Information on each product listed in the Purple Book includes its BLA tracking number, product name, product proprietary name, date of licensure, date of first licensure, reference product exclusivity expiration date, indication as to whether the product is interchangeable (I) or biosimilar (B), and whether the product was withdrawn from the market.61 Other countries have similar lists of approved innovator biologics and biosimilars.

Biologics, Biosimilars, and Biobetters

Подняться наверх