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Supreme Court Speeds Copycat Biologic Drugs to Market

(Reuters) June 12, 2017 - The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies.

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Winston Wong, PharmD (Posted: June 15, 2017)

quotesThis is a big win for biosimilars. While biosimilars may not be discounted as much as expected, we are still seeing cost savings as rebates arrangements are becoming more aggressive. So now the question is whether the biosimilar manufacturers are ready to begin production sooner. quotes

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Howard S. Hochster, MD (Posted: June 13, 2017)

quotesA victory for consumers and cost control. SCOTUS overcame lower court considerations and parsed the BPCIA wording to mean that the biosimilar manufacturer does not need to wait 180 days after FDA approval. They can notify the originator company before actual approval. This cuts out the extra 6 month exclusivity Amgen was seeking. Looking forward to more biosimilar molecules on the market next year. quotes

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