Modern Healthcare (09/17/15) Johnson, Steven Ross

The Food and Drug Administration (FDA) needs to do more in its efforts to set rules for biosimilars, according to members of a Senate Health, Education, Labor and Pensions subcommittee. On Sept. 17, Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told the subcommittee the agency was "on track" to issue guidance on biosimilar interchangeability and labeling by the end of 2015, but she did not offer a specific date. She emphasized that only careful review could assure providers and patients that biosimilars' safety and efficacy were comparable to reference biologics. Sen. Elizabeth Warren (D-Mass.) noted that FDA has had five years to develop its guidance and that further delay could affect the biosimilar drugs' abilities to provide cost savings. A 2014 report by the RAND Corp. estimates that biosimilars could save $44 billion over the next decade as patents for many biologic drugs will expire over the next few years. However, critics argue that, unlike generic drugs, biosimilars are not identical to the original biologics in composition or production. This has led to a debate over interchangeability between biologics and biosimilars. FDA has been developing guidance for how the agency will demonstrate this interchangeability and how biosimilars are to be named.

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