Biosimilars Get Their Own FDA ‘Purple Book’

September 15, 2014

The FDA for the first time has published a reference list for biologics, known as the Purple Book, that will list all brand products and any biosimilars with which they are interchangeable.

The book is similar to the Orange Book for small molecules and represents another step forward as the agency prepares its biosimilar approval pathway.

Every biologic product will be listed in the book, along with date of licensure, whether it was evaluated for reference product exclusivity and when that exclusivity expires. The book also will identify whether the product is biosimilar to or interchangeable with another therapy, the FDA said. Biosimilars and interchangeable products will be listed under their reference version.

The agency has promised to periodically update the book, which actually consists of two separate lists for the products overseen by the Public Health Service (PHS) Act — one for biologics regulated by CDER and the other for those overseen by CBER.

As of now, the two lists exist only as simple spreadsheets in pdf form, unlike the Orange Book’s searchable version. Also unlike the Orange Book, the FDA is not legally obligated to publish a list of biosimilars, said Hyman, Phelps & McNamara attorney Kurt Karst.

The book is formally called the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” But like the Orange Book, the FDA sought to give it an easily remembered nickname, the agency said. The Orange Book technically is called the “Approved Drug Products with Therapeutic Equivalence Evaluations.”

The Purple Book will likely evolve over time much like its Orange predecessor, Karst said. While not necessarily an-earth shattering development, Karst called the Purple Book’s publication helpful, albeit short on information at the moment. “It’ll become more significant as time goes on,” he said, as the FDA develops and approves biosimilars.

Two pharmaceutical companies, Sandoz and Celltrion, so far have announced filing biosimilar applications with agency. No biosimilar has yet been approved under the 2010 pathway. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.