Purple is the new Orange: FDA releases Purple Book for biosimilars

September 18, 2014 6:15 AM

In a major move, the U.S. FDA has released a first edition of the “Purple Book,” which lists biologic products currently licensed in the United States and their interchangeable biosimilars.

FDA’s Orange Book is widely used in the regulatory community (and by doctors) for identifying which drug products are substitutable for one another. – See more at: http://www.raps.org/Regulatory-Focus/News/2014/09/09/20246/In-Major-Move-on-Biosimilar-Interchangeability-FDA-Establishes-New-Purple-Book/#sthash.qiLYXPp2.dpuf

FDA’s Orange Book which was first published in 1980, is widely used for chemicals for identifying which medicines are interchangeable for one another and this new Purple Book will do the same for biologics.

The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act.

The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

Separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be updated periodically.

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