Could Knock Off Pharmaceuticals be the Answer to Lower Priced Biotech Drugs


    Copycat versions of biotech drugs work just as well as the originals and cost a lot less, according to an analysis of studies of the medicines. The analysis by researchers at Johns Hopkins Bloomberg School of Public Health finds that so-called biosimilars – medications that are meant to mimic, and compete with, complex and expensive biotech drugs – perform as well as the brand-name versions.

    The researchers looked at data from 19 studies of biosimilar drugs that treat rheumatoid arthritis, inflammatory bowel disease, and psoriasis, and found that they were comparable to the originals and would cost less. It’s also next to impossible to make an exact copy of a biological product, which is why the drugs are often referred to as biosimilars.

    There was a provision in the Affordable Care Act meant to encourage development and approval of biosimilars, but progress has been slow.
    The Food and Drug Administration has approved only two such drugs since the law passed in 2010. A look inside the factory in Kundl, Austria, where Sandoz, a unit of Novartis, makes biosimilar drugs.

    SHOTS – HEALTH NEWS FDA Decision Signals New Competition For Some Of The Costliest Drugs Zarxio, the first biosimilar drug approved in the U.S., is expected to save about $6 billion a year because it costs less than Amgen’s Neupogen, the brand-name product.

    In April, the FDA approved a second drug that is similar to Johnson & Johnson’s Remicade to treat colitis and Crohn’s disease. That drug, called Inflectra, is one member of the class of biosimilars that the researchers at Johns Hopkins examined. There are several other biosimilar drugs in this class available in Canada, Asia, and Europe.

    The Johns Hopkins study is important because drugmakers have raised questions about biosimilars since they aren’t identical to the drug they’re supposed to mimic. Many are fighting approval of the drugs, and some argue that they should not be substituted for a brand-name drug without a patient’s consent.

    IMS Health Informatics says there are 50 biosimilars under development.
    All told, they could save U.S. and European health systems as much at $110 billion over the next five years, the company estimates.


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