The Biotechnology Industry Organization has criticized the introduction of legislation in the US Senate to create a regulatory pathway for generic versions of biotechnology drugs, which was proposed by Senators Susan Collins (Republican, Maine), Charles Schumer (Democrat, New York), Mel Martinez (Republican, Florida) and Sherrod Brown (Democrat, Ohio).
Jim Greenwood, the BIO's president, said: "while well-intentioned, the bill introduced today by Sens Schumer, Brown, Collins and Martinez follows its companion bill in the House (HR 1427, the Promoting Innovation and Access to Life-Saving Medicine Act) through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs."
Biologics "too complex" for quick generic approval by the FDA
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