FDA Issues "Purple Book" for Biosimilars

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 09-10-2014 13:28

The US Food and Drug Administration (FDA) has issued its “Purple Book” to lists biological products, including any biosimilar and interchangeable biological products licensed by the FDA under the Public Health Service Act (the PHS Act). The "Purple Book," formally known as Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, is the biological equivalent of the FDA's "Orange Book," formally known as the Approved Drug Products with Therapeutic Equivalence Evaluations, which identifies drug products approved on the basis of safety and effectiveness by the FDA and includes therapeutic equivalence evaluations for approved multisource prescription drug products (i.e., generic drugs).

The Purple Book will lists that contain 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. CDER regulates prescription drugs, including biological therapeutics, and CBER regulates biological products, such as blood, vaccines, allergenics, tissues, and cellular and gene therapies.
CDER's list of licensed biologics products be found here, and CBER's list of licensed biologics products may be found here. Further information on the lists in the Purple Book may be found here

Source: FDA


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