Biosimilars & FDA’s New “Purple Book”

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Biosimilars & FDA’s New “Purple Book”

As many of you know the FDA’s nickname for the “Approved Drug Products with Therapeutic Equivalence Evaluations” is the “Orange Book.”  And now for the newest color—purple. The FDA has now nicknamed its lists of biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act) the “Purple Book.”

The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amended the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to, or “interchangeable,” with an FDA-licensed biological product. A biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product [1].

Delfini Comment

More information about biosimilars, the Purple Book and the first FDA approved biosimilar product—Zarxio—is available at the following FDA site below [2]. For those wishing more background information see our previous blog, Is “Biologics Versus Biosimilars” A Different Story Than Brand Names Versus Generics? Available at http://delfini.org/blog/?p=100.

References

  1. BPCIAct.
    http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
    HowDrugsareDevelopedandApproved/ApprovalApplications/
    TherapeuticBiologicApplications/Biosimilars/ucm241719.htm

    Accessed 3/9/15
  2. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
    HowDrugsareDevelopedandApproved/ApprovalApplications/
    TherapeuticBiologicApplications/Biosimilars/default.htm

    Accessed 3/9/15
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