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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Genomic Medicine Leaps Forward—More Drugs Targeting More Cancers

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Genomic Medicine Leaps Forward—More Drugs Targeting More Cancers

Genomic Medicine Leaps Forward—More Drugs Targeting More Cancers We, like others, have been watching to see how genetic information will improve health outcomes (genomic medicine). Recently we encountered two pieces worth reading. The first is the NCI Molecular Analysis for Therapy Choice Program (MATCH) which will conduct small, phase II trials that will enroll adults with advanced solid tumors and lymphomas whose tumors are no longer responding to standard therapy and have begun to grow. Subjects will receive drugs targeting specific genetic abnormalities common across cancers. What is unique is that DNA sequencing will be used to identify individuals whose tumors of various types have specific genetic abnormalities that may respond to selected targeted drugs. Study arms (baskets) are created by cancer type, and multiple drugs can be studied. Details are available at— http://www.cancer.gov/clinicaltrials/noteworthy-trials/match.

The second piece titled, “A Faster Way to Try Many Drugs on Many Cancers,” by Gina Kolata and published in the New York Times (http://www.nytimes.com/2015/02/26/health/fast-track-attacks-on-cancer-accelerate-hopes.html?_r=0) provides examples of some of the clinical trials with basket designs, often referred to as “basket trials” because patients are also grouped by genetic abnormality rather than cancer type.

Delfini Comment
These trials will rely on surrogate markers (progression free survival and response rates), but may be useful if effect sizes are large. Investigators are interested in these trials because they can be done rapidly and are not constrained by many of the requirements of RCTs. You can quickly get the idea of the basket trial designs by looking at the first link above and the FDA site below. The FDA appears to be supportive of these initiatives and has created a PowerPoint slide deck with additional information about basket trials,including specific cancers and drugs at— http://www.fda.gov/downloads/Drugs/NewsEvents/UCM423361.pdf.

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