Without saying what effect the partial government shutdown could have on the agency’s agenda, U.S. Food and Drug Administration (FDA) personnel reportedly indicated during a regulatory conference in Boston that the draft biosimilar guidances issued in February 2012 were nearing completion and could be finalized within the next year. According to a news source, FDA Senior Staff Fellow Sue Lim reported that labels for biosimilars will, for the most part, be the same as those for branded biologics, with some differences to distinguish the drugs. Lim also said that a particular challenge has been the science of highly complex biologic drugs, with the agency focusing study on the relationship between protein attributes and effects on clinical effectiveness and safety. Her remarks were made during the Regulatory Affairs Professional Society’s “2013 RAPS: The Regulatory Convergence” conference. See Law360, October 2, 2013.
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