Why Is The FDA Green Lighting Copy Cat Drugs


    Back In 2016, Roche Holding AG sold $3 billion worth of its big-time biotechnology drug Avastin. Just this past week, the U.S. Food and Drug Administration approved what is anticipated to be a less-expensive version.

    Patients and insurers will not be able to start counting the savings anytime soon.

    Out of seven so-called biosimilar treatments, the FDA has cleared since the first approval of one of the drugs back in 2015, only three are available for sale. The rest is tied up in legal disputes that can block the cheaper versions for years.

    Essentially, there is so many patents,” Gillian Woollett, senior vice president at the consulting firm Avalere Health and an expert on the drugs. The makers of the original drugs are willing to use those patents to keep competitors out. “You’ve got some extremely well-established products with substantial resources behind them.”

    Congress made a road that leads to the market for biosimilars in 2010 as part of the Affordable Care Act. The goal was to give patients access to cheaper versions of costly drugs made from living cells, which until the law didn’t have a path for copycats. Generic versions of traditional pills can cost pennies on the dollar compared to brand-name versions and have saved the U.S. health system $1.67 trillion in the last decade, according to a report by the Association for Accessible Medicines.

    Roche’s drug, Avastin, costs about $73,000 to $148,000 a year, depending on the type of cancer the patient has, according to the company. While biosimilars are expected to be less costly than the brands, they also require more testing and manufacturing resources, so won’t have the sharp price reductions of pill-form generics.

    Getting the biotechnology drug copies to market is not only about getting them cleared and ready to sell. Because of their complexity, biologic drugs can have more than 100 patents — which can be used to fend off competition. One step involved in getting the copycats to market is the “patent dance,” where the two sides try to agree on which patents will be involved in initial litigation. More lawsuits can be filed later.


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