Tuesday, September 9, 2014

FDA Establishes New "Purple Book" for Biosimilars

It may not make the New York Times’ Best Seller List, but the release of the FDA’s new book is certainly noteworthy.  The FDA today announced that they’ve published their first ever edition of the “Purple Book”, a list of licensed biological products and interchangeable biosimilars. 

The organization’s new list will serve a similar role to that of its counterpart in the pharmaceutical industry, the Orange Book, and will look to answer questions around the substitutability of products.  Many have voiced concerns over the extent to which biologics and biosimilars will be used interchangeably.  Although aimed to replicate the biologics they’re designed after, biosimilars are not identical to those drugs and therefore are not necessarily perfect substitutes in all cases.
Purple Book Biosimilars Biologics FDA list licensed

The FDA has indicated that they will use a four part scale to categorize the interchangeability: 
  •         Not similar
  •         Similar
  •         Highly similar
  •         Highly similar with a fingerprint-like similarity

The book is broken up into two sections—biologic products regulated by the Center for Drug Evaluation and Research (CDER) and those regulated by the Center for Biologics Evaluation and Research (CBER). Among the information included in these lists is the date a biologic was licensed, the product name, the proprietary name and the BLA number. 

As we begin to see biosimilar applications roll in, we may see this list build out rather quickly over the next few years. 

You can find the announcement from the FDA here.

We’ll have more on the latest developments in the biosimilars market at the 15thAnnual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.
SAVE $100.  Register here and use code XP1986BLOG.

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