Biotechs Push FDA For Clear-Cut Biosimilar Labeling Rules

Law360, Washington (May 11, 2012, 7:26 PM EDT) -- Several biotechnology companies told the U.S. Food and Drug Administration on Friday that while they supported its proposed regulations for biosimilar drugs, the agency needed to clarify naming, labeling and approval standards for the products to alleviate concerns in the industry.

Representatives for Abbott Laboratories, Mylan Inc., Pfizer Inc., and other companies and trade organizations expressed their concerns at the FDA's public hearing over its proposed guidelines for the approval of biosimilars, or generic biologic drugs, saying that without more specific agency input, health care providers...
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