FDA finalizes rules for when a biosimilar is ‘interchangeable’ with a biologic

first_img Tags biosimilarbiotechnologydrug pricinggovernment agenciespharmaceuticalspolicySTAT+ Log In | Learn More Ed Silverman Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED WASHINGTON — The FDA on Friday spelled out exactly what kind of studies biosimilar drug makers must conduct in order to be considered “interchangeable” with a biologic drug the way a generic functions for a normal medicine.It’s the agency’s final word on a controversial and long-running fight over how it will define those rules for the pricey category of biologic drugs, the complex drugs made from living organisms used to treat conditions like cancer, and their copycat biosimilars. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. About the Authors Reprints What’s included? [email protected] Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. [email protected] STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.center_img The Food and Drug Administration Andrew Harnik/AP GET STARTED Washington Correspondent Nicholas Florko reports on the the intersection of politics and health policy. He is the author the newsletter “D.C. Diagnosis.” FDA finalizes rules for when a biosimilar is ‘interchangeable’ with a biologic Politics @Pharmalot @NicholasFlorko By Nicholas Florko and Ed Silverman May 10, 2019 Reprints Nicholas Florko What is it?last_img

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