It is official; FDA has announced the availability of "Purple Book," as its first publication to inform the industry of the degree of similarity between a biological product and its respective reference product. The Purple Book is meant to provide the same function as the FDA's Orange Book, but for products licensed under section 351(k) of the Public Health Service Act (PHS Act). It primarily helps a user to see whether a particular biological product has been determined by FDA to be biosimilar to or interchangeable with a reference product. In its current version, the Purple Book includes two separate lists of products, one containing the products regulated by the Center for Drug Evaluation and Research (CDER) and the other by Center for Biologics Evaluation and Research (CBER). Each list provides the product's name, the date of licensure as well as the date of first licensure of the reference product, which clarifies the date from which the reference product's exclusivity begins to run. Determining the applicable exclusivity and extent of patent protection from the Purple Book, however, require further diligence. For example, a listing of applicable patents is not available in the current version. Orphan drug status must also be independently determined.
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