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    Looking Into The Future Biosimilar Landscape: A Case Study

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    This document summarizes a presentation given by Helen Hartman of Pfizer on the importance of unique identifiers for biosimilar drugs. Hartman argues that each biosimilar needs both a distinguishable nonproprietary name and a unique trade name to ensure accurate reporting of adverse events and safeguard patient safety. Two case studies, one involving biologics and one small molecules, show that generic drugs identified only by nonproprietary name lead to 14% of adverse event reports not identifying the manufacturer, whereas distinctive brand names allowed accurate reporting for 95% of biologic cases. Hartman concludes that both a unique nonproprietary name component and trade name are necessary to facilitate proper adverse event reporting for biosimilars.

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    Looking Into The Future Biosimilar Landscape: A Case Study

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    shashank
    61 views9 pages
    This document summarizes a presentation given by Helen Hartman of Pfizer on the importance of unique identifiers for biosimilar drugs. Hartman argues that each biosimilar needs both a distinguishable nonproprietary name and a unique trade name to ensure accurate reporting of adverse events and safeguard patient safety. Two case studies, one involving biologics and one small molecules, show that generic drugs identified only by nonproprietary name lead to 14% of adverse event reports not identifying the manufacturer, whereas distinctive brand names allowed accurate reporting for 95% of biologic cases. Hartman concludes that both a unique nonproprietary name component and trade name are necessary to facilitate proper adverse event reporting for biosimilars.

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    This document summarizes a presentation given by Helen Hartman of Pfizer on the importance of unique identifiers for biosimilar drugs. Hartman argues that each biosimilar needs both a distinguishable nonproprietary name and a unique trade name to ensure accurate reporting of adverse events and safeguard patient safety. Two case studies, one involving biologics and one small molecules, show that generic drugs identified only by nonproprietary name lead to 14% of adverse event reports not identifying the manufacturer, whereas distinctive brand names allowed accurate reporting for 95% of biologic cases. Hartman concludes that both a unique nonproprietary name component and trade name are necessary to facilitate proper adverse event reporting for biosimilars.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    61 views9 pages

    Looking Into The Future Biosimilar Landscape: A Case Study

    Uploaded by

    shashank
    This document summarizes a presentation given by Helen Hartman of Pfizer on the importance of unique identifiers for biosimilar drugs. Hartman argues that each biosimilar needs both a distinguishable nonproprietary name and a unique trade name to ensure accurate reporting of adverse events and safeguard patient safety. Two case studies, one involving biologics and one small molecules, show that generic drugs identified only by nonproprietary name lead to 14% of adverse event reports not identifying the manufacturer, whereas distinctive brand names allowed accurate reporting for 95% of biologic cases. Hartman concludes that both a unique nonproprietary name component and trade name are necessary to facilitate proper adverse event reporting for biosimilars.

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    of 9

    Looking Into the Future Biosimilar Landscape:

    A Case Study
    Federal Trade Commission Public Workshop:
    Impact of Recent Legislative and Regulatory Naming Proposals on Competition
    4 February 2014

    Helen B. Hartman, Ph.D.


    Worldwide Regulatory Strategy
    Worldwide R&D, Biosimilars Business Unit
    Pfizer, Inc.

    Disclaimer:
    The opinions expressed in this presentation are solely those of the presenter and should not be construed to
    reflect the views of Pfizer.

    .
    Biosimilar Naming: Unique Identifier Essential
    to Safeguard Patient Safety
     Pfizer is committed to the development of innovator biologic products
    and biosimilars
     Pfizer’s clinical stage pipeline in biosimilars includes five monoclonal antibodies (mAb)
    ranging from Phase 1 through Phase 3

     Pfizer has previously called for a balanced, science-based approach to biosimilar naming
    and labeling*
     Each subsequent entry biological product should have a distinguishable identifier (for
    example, either the USAN/INN name followed by the manufacturer’s name and/or a
    trade name)
    and
     Its own label containing a prominent statement regarding its biosimilarity and/or
    interchangeability status with regard to each indication

     A distinguishable identifier (either a different non-proprietary name or a trade


    name) is essential to safeguard patient safety and is supported by regulatory
    science*
    *Pfizer presentation at the Part 11 Hearing before the Commissioner in Nov 2010, as
    well as written submission to the Docket associated with that Hearing.

    2
    .
    Two Case Studies in Traceability of Manufacturer
    Information in AE Reporting
     To inform Pfizer’s current position on the “INN Debate”, we conducted our own
    internal research on two case studies that provide insight into the world of AE
    reporting and the traceability of the manufacturer information in the US

    Case Study: Biologic Case Study: Small Molecule


     Multiple branded products  Branded product + multiple generics
     Same INN on the market
     Not “interchangeable” nor subject  Same INN
    to pharmacy substitution  Interchangeable, and subject to
     Physician or self-administered substitution as permitted under state
    law

    Analysis
     Primary Objective: To determine the frequency of cases containing
    identifiable manufacturer information (e.g., trade name provided by
    reporters) in Pfizer’s global safety database
     Secondary objective: To determine the frequency of cases which
    specifically included National Drug Code (NDC) information

    3
    .
    Methodology:

    Dataset for analysis:


    US Spontaneous Cases

    #Cases #Cases #Cases


    Pfizer Product Identified Generic Name Identified; Other Manufacturer
    Manufacturer unknown Product Identified

    #Cases
    NDC Provided

    4
    .
    Results: Small Molecule

    Dataset for analysis:


    All other spontaneous AE cases

    ~83% ~14% ~3%


    Tradename Identified Generic Name Identified; Other Manufacturer
    Manufacturer unknown Product Identified

    <2% NDC Provided…


    (and 1/6 were inaccurate numbers)

    * Data for 2013

    .
    Results: Biologic

    Dataset for analysis:


    US Spontaneous Cases

    ~ 95% < 1% ~4%


    Tradename Identified Generic Name Identified; Other Manufacturer
    Manufacturer unknown Product Identified

    ~9% NDC Provided


    (1/3 were inaccurate numbers
    *Data for 2009-2013

    .
    Case Studies and Lessons Learned
    Small Molecule Case Study

     Results: 14% of reported AE cases had no identifiable manufacturer

     Conclusion:
    • Use of non-distinct INN, in the absence of distinguishable trade names does
    not allow AE reports to be accurately linked to the manufacturer
    • A distinguishable identifier either Trade name or INN is critical

    Biologic Case Study


     Results: Less than 1% of reported AE cases had no identifiable manufacturer
     Conclusion:
    • Distinct trade/brand names allow for more accurate reporting to the
    appropriate manufacturer irrespective of the INN in a setting in which all
    “similar” products have a distinct invented trade name

    7
    .
    In the Absence of a Trade Name, Additional
    Product-Specific Identifiers are Essential
     Not clear that global agencies can require a manufacturer to have a distinct
    invented trade/brand name
     However, given that pharmacovigilance is global, the naming system should
    also be global.
     There are issues of practicality and enforceability of a “mixed” system, in
    which some products are branded and some have unique INNs.

     In the absence of a specific requirement for a trade name, dual identifiers are
    critical
     The necessity for dual product-specific identifiers is reflected in revised
    Pharmacovigilance Directive 2010/84/EU which mandates that reporting
    information include (1) Trade Name and (2) batch number

     Can the NDC function as an additional product-specific identifier in the US?


     No. Our primary data show that NDC numbers are rarely reported, and
    may be inaccurate.
     These findings are consistent with other published studies*

     Therefore a distinguishable INN-based identifier, in addition to distinct invented


    Trade name, would help ensure accurate AE reporting
    * Lietzan et al., Biosimilar Naming: How Do Adverse Event Reporting Data Support the
    Need for Distinct Nonproprietary Names for Biosimilars? (2013); Kevin Olson, Alliance 8
    For safe Biologic Medicine: Prescriber Survey (2012)
    .
    Summary
     A balanced, science-based approach to biosimilar naming and labeling is
    needed

     Any naming policy for biosimilar products must be a viable, long-term solution
    that adequately address safety issues and anticipates the future biosimilar
    landscape

     A distinct Trade/Brand name is necessary for accurate AE reporting (e.g.


    Biologic Case Study)
     In the absence of a requirement that all biosimilars and follow-on biologics
    adopt unique trade names, then it is likely that the identification of
    manufacturers in AE reporting will be hindered if the products share the same
    INN (e.g. Small Molecule Case Study)
     Therefore, both a distinguishable INN plus a specific brand name would
    increase the accuracy of AE reporting
     For example: INN comprised of common roots plus distinguishable prefixes or
    suffixes

    9
    .

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