Many of us are familiar with the Orange Book, the US Food and Drug Administration (FDA) publication of information on approved small-molecule drug products, and therapeutic equivalence information. The Orange Book also sets out details of patents which are purported to cover each approved drug.
The Orange Book stems from the Drug Price Competition and Patent Restoration Act (known as “Hatch-Waxman Act”), which was designed to reduce the cost of prescription drugs, while balancing the interests of so-called “innovator” drug companies (who market branded products) and their competition, the generic drug manufacturers. The listing of patents in the Orange Book is important, because a listed patent may prevent (or delay) approval for a generic version of a drug, for example until patent expiry, or until it can be shown that the patent is invalid or does not cover the generic product.
The Orange Book covers small-molecule drug products. Increasingly, there is development of medicinal products which are produced in or extracted from biological sources such as living cells. These biological products are also known as biopharmaceuticals or biologics, and are generally very much larger than small-molecule drug products – examples include vaccines, and recombinant proteins such as EPO.
The Patient Protection and Affordable Care Act of 2010 – Obamacare – included the Biologics Price Competition and Innovation Act, which provides a mechanism for marketing authorisation for a generic equivalent of a biologic. These generic equivalents of biologics are sometimes known as biosimilars, and it is expected that the first biosimilars will be approved next year.
The FDA has recently announced creation of the Purple Book, which will list all approved FDA biological products, including biosimilars and interchangeable biological products (when approved). The Purple Book listing should include details of whether any biologic has been designated by the FDA to be a biosimilar or interchangeable with a reference product (that is, an already-licensed FDA biological product), which may enable a doctor or pharmacy to prescribe/issue a more affordable equivalent. The Purple Book listing will include the date a biological product was licensed and whether FDA evaluated the biological product for reference product exclusivity.
A link to the purple book can be found here.
There are two lists that make up the Purple Book, which are understood to be one for biologics approved by the drug division of the FDA and the other for biologics approved by the biologics division of the FDA. The lists will be updated periodically.
The Purple Book does not include a listing of patents for approved biologics, and it is believed that the FDA do not plan to include such information. This is because no patent information is supplied to the FDA as part of a biologic approval. The absence of patent information means that while the Purple Book will enable monitoring of approval of biosimilars, it will not be able to provide full guidance as to when a competitor may enter the market, for example.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.