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FDA comes out with ‘Purple Book’ to catalog biologics and biosimilars

In a move that heralds greater momentum toward regulating biosimilars, the Food and Drug Administration has published its first-ever “Purple Book” – a list of all FDA-licensed biologics and the biosimilars that can be used in their stead. It’s meant to be equivalent to the FDA’s “Orange Book” – the go-to list for physicians, regulatory agents and […]

In a move that heralds greater momentum toward regulating biosimilars, the Food and Drug Administration has published its first-ever “Purple Book” – a list of all FDA-licensed biologics and the biosimilars that can be used in their stead.

It’s meant to be equivalent to the FDA’s “Orange Book” – the go-to list for physicians, regulatory agents and generics makers, as it is a list of all FDA-approved drugs. It indicates which med can be interchanged for which – and lists out important patent exclusivity information.

The Regulatory Affairs Professionals Society spells out why the Purple Book is different – and why it’s an important move for the FDA.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Due to manufacturing differences, biosimilar products are not exactly the same as the products they aim to replicate.  While FDA’s regulatory processes are intended to ensure that an approved biosimilar product is therapeutically similar or the same as a reference biologic product, many regulatory experts have expressed concern about how companies will be able to illustrate interchangeability without extensive testing.

And now, just weeks after receiving two applications for approval for biosimilar products (Zarzio and Remsima), FDA is for the first time releasing a look at its Purple Book.

Additionally, here’s an interesting point from FDA Law Blog:

Unlike the Hatch-Waxman Amendments, which require the publication of “a list” (i.e., the Orange Book) … the Biologics Price Competition and Innovation Act (“BPCIA”) does not require FDA to publish a list of licensed biological products, including applicable patent and non-patent exclusivities.

Nevertheless, FDA has taken the initiative to create a reference guide. In fact, FDA’s decision to publish the Purple Book is not unlike FDA’s initial, pre-Hatch-Waxman decision to create the Orange Book.

The term “Orange Book caught on because the real report’s quite the mouthful – “Approved Drug Products with Therapeutic Equivalence Evaluations.” Why purple? The FDA says:

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FDA wanted a similarly user-friendly term for a reference listing biologics, biosimilars, and interchangeable products. During a meeting, a staff member said, “how about purple?” Ever since, we’ve called it the “Purple Book.”

There are two lists, which can be seen in PDF form at the links below:

Center for Biologic Evaluation and Research

Center for Drug Evaluation and Research