FDA updates Purple Book for biologicals and biosimilars

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FDA updates Purple Book for biologicals and biosimilars

Biosimilars/General | Posted 10/03/2017 0 Post your comment

On 21 February 2017, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the ‘Purple Book’.

The Purple Book is a set of lists of licensed biological products and biosimilars that are meant to be the biological equivalent of the ‘Orange Book’, which lists pharmaceuticals and their generic equivalents.

FDA published the first-ever edition of the Purple Book in September 2014 [1]. The book lists biological products, including any biosimilar and interchangeable biological products licensed by FDA. It includes the date of licensure of the reference product, whether a product is biosimilar or interchangeable and reference product exclusivity expiry dates.

The date of first licensure is important, as it will determine when a biosimilar manufacturer can submit an application to FDA via the abbreviated biosimilars approval pathway. Draft guidance issued by FDA in August 2014 makes it clear that originator biologicals will enjoy a period of 12 years of marketing exclusivity on their products from the date of first licensure, as well as a further six months of exclusivity if the sponsor conducts paediatric studies [2].

The Purple Book now contains the US-approved biosimilars Amjevita (adalimumab‑atto), Erelzi (etanercept-szzs), Inflectra (infliximab-dyyb) and Zarxio (filgrastim-sndz), all of which are indicated to be biosimilar.

FDA’s Orange Book is widely used by both the regulatory community and by physicians in order to identify which drugs are substitutable for one another. The Purple Book is intended to be used in the same way. However, as yet there are no interchangeable products listed in the Purple Book.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA debuts purple book for biologicals and interchangeable biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 10]. Available from: www.gabionline.net/Biosimilars/General/FDA-debuts-purple-book-for-biologicals-and-interchangeable-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA releases draft guidance on reference product exclusivity for biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 10]. Available from: www.gabionline.net/Guidelines/FDA-releases-draft-guidance-on-reference-product-exclusivity-for-biologicals

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Source: US FDA