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    Biosimilar offers hope of lower-cost treatment of autoimmune diseases

    While an FDA panel recently decided that Celltrion's biosimilar, Remsima (infliximab), is “highly similar” to the branded monoclonal antibody, Remicade (infliximab), in its effect on a variety of autoimmune diseases, it is unclear when Remsima will be available or what the cost will be.

    A sign of big business to come

    Still, the impending final approval of Remsima by FDA is just one signal that biosimilars will be big business in the United States soon. Some industry sources estimate that biosimilars could provide as much as $250 billion in savings over the next decade, while the Congressional Budget Office estimates a 10-year savings of around $25 billion.

    However, a report from American Action Forum (AAF) provided a much lower savings estimate for biosimilars, hypothesizing a figure between $5.1 billion and $37.8 billion on drug expenditures from 2015 through 2024.

    The AAF’s savings estimate may be lower because the organization takes into account whether physicians and pharmacists will actually recommend biosimilars to patients — along with the discounts that manufacturers of biosimilars may be able to offer.

    “Unlike traditional generic drugs, it is expected that the relatively low discounts and high-investment cost expected with biosimilars will create competition between biosimilars and brand-name biologic drugs that is more similar to competition between brands than between a brand and a generic,” wrote Conor Ryan, author of the AAF report and an outside health expert for the AAF.

    Estimated savings of 25%

    Experts estimate that Remsima, which is already available in many European countries, will be priced around 25% lower than Remicade in the United States.

    Alex KudrinAlex KudrinVibeke StrandVibeke StrandHowever, the price for the biosimilar infliximab is not yet determined, so “it is not appropriate for us to assume the size of cost savings to consumers and the U.S. healthcare system,” Alex Kudrin, MD, PhD, and and Vibeke Strand, MD, told Drug Topics via e-mail. Kudrin is vice president of clinical development for Celltrion and Strand is an adjunct clinical professor in the Division of Immunology/Rheumatology, Stanford University School of Medicine.

    The price of the biosimilar drug varies among countries, since it is set according to the local regulations and pricing systems.

    “Celltrion, as a biosimilar developer, is committed to delivering high-quality, affordable medications. We hope that biosimilars’ price is determined in a way that it contributes to larger cost-savings and better treatment opportunities granted to patients,” Kudrin and Strand said.

    It is too early to speculate on when the drug will launch, since Pfizer will handle the release, they added. Pfizer assumes the U.S. commercialization rights for the biosimilar monoclonal antibody and plans to market the drug under the brand name Inflectra.

    Christine Blank
    Contributing Editor Christine Blank is a freelance writer based in Florida.

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