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Biosimilars Law Blog
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Making U.S. Biosimilars a Reality – Everyone Seeks Clarity and Direction from FDA

The usual suspects from regulated industry, patient and physician groups turned out for the U.S. Food and Drug Administration’s public meeting on the biosimilars guidances.  Now that the draft guidances have been out for several months and the FDA has a stack of comments to consider, the dialogue has moved from the theoretical to the practical:  How is this really all going to work?

Stakeholders lined up for their turns at the podium at the Public Hearing held on May 11, 2012.  To be sure, there were the predictable disagreements among stakeholders on issues such as naming and interchangeability, in addition to the now-familiar (and sometimes conflicting) views on the need to protect patient safety, encourage product innovation, and create meaningful cost-savings.  However, the strong consensus that FDA should implement an education and communication plan about biosimilars was noteworthy.  For example, a speaker from the American Pharmacists Association said pharmacists don’t know what to expect or do when they start seeing prescriptions for biosimilar products. Patient advocates and physician groups also said their constituents will need additional educational materials and are interested in interactive presentations from FDA on the appropriate use of these new products. 

It’s not clear what steps FDA will take to articulate clear policy and provide guidance in these areas.  At the hearing, however, the agency asked speakers for details and supporting data, and encouraged everyone to submit these and other concrete suggestions on implementation to the docket (FDA-2011-D-0618), which is open until May 25th.