The Biologic Patent Transparency Act (BPTA), a Senate bill introduced by Senator Susan Collins (R-ME) in March, is an independent, bipartisan attempt to address patent thickets. It does so largely by clarifying an individual biologic product’s patent situation. In achieving this, it can also create a real reason for the existence of the Purple Book. … Continue reading Senate Bill on Patents Could Turn the Purple Book Into Something More Useful
Tag: Purple Book
FDA Purple Book: Much Potential Value, Little Current Help
Under the BPCIA, the FDA Purple Book is the published agency reference on biosimilars. It lists very specific information with regard to both the reference biologics and biosimilars: (1) biologic licensing application number, (2) nonproprietary name, (3) proprietary name (brand name), (4) date of licensure, (4) reference product exclusivity expiration, and (5) whether the product … Continue reading FDA Purple Book: Much Potential Value, Little Current Help