US senators call for guidance on biosimilars

Biosimilares/General | Posted 05/09/2014 post-comment0 Post your comment

A growing number of US senators are calling on the country’s Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) to release guidance on key scientific policy questions related to biosimilars.

Guidance V13F21

In a letter to the HHS Secretary Ms Sylvia Burwell, dated 30 July 2014, Kay Hagan, the junior Senator from North Carolina, called on the HHS to complete its review of draft guidance on biosimilar naming. Once this is released, FDA will be able to publish the document for public comment.

‘A transparent and timely process for implementing the biosimilars pathway is essential so all stakeholders have a clear understanding of the agency’s expectations for the review of biosimilars,’ writes Senator Hagan, in the letter made public on the Alliance for Safe Biologic Medicines website. According to the letter, there are over 20 biosimilar products in clinical development, but several outstanding issues must be addressed before the first biosimilar can be approved. Senator Hagan was primary author of the Biologics Price Competition (BPCI) Act of 2009, which established a regulatory pathway for the licensure of biosimilars in the US.

Hagan’s letter landed in Burwell’s in-tray just as a separate letter from a group of five further republican senators also called on the Health Secretary to release guidance documents on biosimilar drug approvals.

Senators Lamar Alexander, Orrin Hatch, Richard Burr, Mike Enzi and Pat Roberts wrote of their concerns about the implementation of the BPCI Act, bipartisan legislation enacted in 2010 to provide FDA with a framework to review and approve biosimilars.

‘The FDA has not yet issued guidance on some of the key scientific policy questions related to biosimilars, such as naming, labelling, indication extrapolation and interchangeability,’ write the senators in a letter released online by the US Senate Committee on Health, Education, Labour and Pensions.

The World Health Organization’s Programme on International Nonproprietary Names recently released their draft Biological Qualifier proposal on which to base a globally recognized naming scheme for biological products, including biosimilars [1].

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1.    GaBI Online - Generics and Biosimilars Initiative. WHO proposal offers clarity for biosimilar nomenclature []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 5]. Available from:

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Source: Safebiologics, US Senate

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