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Name change to sub-forum

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    Name change to sub-forum

    This has been changed to Betaseron; Extavia. They are two different brand names for the same generic drug - interferon 1-b.
    1st sx '89 Dx '99 w/RRMS - SP since 2010
    Administrator Message Boards/Moderator

    #2
    I'd like to suggest a punctuation change in the subforum title from a semicolon to a slash: Betaseron/Extavia.

    Also, did you mean to say: They are two different brand names for the same drug - interferon beta-1b?

    Until there actually is a generic version available, it isn't quite correct to say that they are versions of a generic drug. They are brand name labels of the same chemical, which is not available as a generic drug. I think that will help to avoid the confusion that already exists about these 2 medicines.

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      #3
      Thanks for the clarification, MSer102! Yes, same names for the drug interferon beta 1b.
      1st sx '89 Dx '99 w/RRMS - SP since 2010
      Administrator Message Boards/Moderator

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        #4
        further clarfication

        This is from 2010, but thought this information might still be helpful to anyone considering Extavia ~

        Interferon 1b Extavia Abbreviated Drug Monograph

        September 2010


        Executive Summary
        -Biologic drugs do not have generic equivalents
        -There are no head to head trials of Extavia® vs. Betaseron® available.
        -The FDA did not grant Extavia® therapeutic interchangeability with Betaseron®, but approved Extavia® with the same active ingredient and registration trials as Betaseron® 250 mcg.
        -Novartis signed an agreement with Bayer Schering Pharma AG that gives Novartis the rights to its own branded version of interferon beta-1b
        -The differences between the two IFN beta-1b products are that the Extavia® brand comes with a 27-gauge needle, packaged with 15 vials for a 30 day supply, while the Betaseron® brand has 30-gauge needles, packaged with 14 vials for a 28 day supply. The difference in package size correlates to 12 packages for Extavia® for a year of therapy versus 13 for Betaseron®.

        Introduction
        Interferon beta-1b (IFN beta-1b) is an immunomodulator used in the treatment of Multiple sclerosis (MS). It is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. On August 14, 2009 the FDA approved Extavia®, a new branded version of interferon beta-1b, is the same product as Betaseron®. Extavia® 250 mcg contains the same active ingredient as Betaseron® 250 mcg, with a separate Biologic License Agreement (BLA) filed by Novartis.

        Background
        -Novartis signed an agreement with Bayer Schering Pharma AG that gives Novartis the rights to its own branded version of interferon beta-1b. (Media release, personal correspondence)
        * 1993: Chiron began manufacturing Betaseron® for Berlex
        * 2006: Novartis acquired Chiron and Bayer purchased Berlex
        * 2007: Novartis and Bayer finalize agreements that allow Novartis to sell interferon beta-1b under the brand Extavia
        * Extavia® will have the same production as Betaseron® (e.g., both are manufactured on the same production line and have similar package inserts)

        Generic Availability (Federal Trade Commission, Food and Drug Administration)
        -Biologic drugs do not have generic equivalents. Congress has introduced legislation to establish regulations to market lower cost generic biologics, also known as follow-on biologics (FOB). Lower-priced FOBs are like generic drugs, but with differences.
        -According to the FDA, current technology does not allow for an exact replica of a pioneer biologic drug product. Technology also does not let us conclusively determine whether a FOB product is “interchangeable” with the original branded product such that a patient would be able to switch between the two products without the risk of an adverse effect. Current legislative proposals permit FDA approval of an FOB drug that is sufficiently similar to, but not an exact reproduction of, the original branded biologic product
        -FOB products will not be designated as “therapeutically equivalent” with the original biologic drug product.

        Comparison to Betaseron
        -The differences between the two IFN beta-1b products are the Extavia® brand comes with a 27-gauge needle, packaged with 15 vials for a 30 day supply, while the Betaseron® brand has 30-gauge needles, packaged with 14 vials for a 28 day supply. (Package Inserts)

        Support Programs.- Extavia® has a support program run by registered nurses similar to Betaseron’s® Betaplus support program.

        Place in Therapy (American Academy of Neurology)
        Extavia® holds the same place in therapy as Betaseron®, Avonex®, and Rebif® in treating RRMS.
        On the basis of several consistent Class I studies, IFN-beta has been demonstrated to reduce the attack rate (whether measured clinically or by magnetic resonance imaging [MRI]) in patients with MS or with clinically isolated syndromes who are at high risk for developing MS it is appropriate to consider IFN-beta for treatment in any patient who is at high risk for developing clinically definite MS (CDMS), or who already has either RRMS or secondary progressive MS (SPMS) and is still experiencing relapses.

        Cost Analysis
        Drug
        Price per vial
        Yearly Cost/Pt (2010)
        Betaseron®
        $58.15
        $10,467.00
        Extavia®
        $60.32
        $10,857.60

        Conclusions
        There is no compelling evidence to support the use of IFN beta 1b product over another. The registration trials for Betaseron® were used in the approval of Extavia®. The impact of different needle gauges between the products may influence patient preference, though this has not been evaluated in any clinical trials. The safety profiles for both agents were based on the Betaseron registry trials.

        Source va.gov
        Last edited by Kimba22; 08-16-2016, 12:37 PM.
        Kimba

        “When you change the way you look at things, the things you look at change.” ― Max Planck

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