FDA announces public hearing on biosimilars’ guidelines

Biosimilars/General | Posted 23/03/2012 post-comment0 Post your comment

FDA has announced a one-day public hearing to be held on 11 May 2012, in Silver Spring, Maryland, USA. During the meeting FDA hopes ‘to obtain input on recently issued draft guidelines relating to the development of biosimilar products.’


FDA issued three draft guidance documents on 10 February 2012 on biosimilar product development to assist industry in developing such products in the US [1].

The purpose of the public hearing is twofold. First, FDA wishes to receive comments on the three draft guidelines from a wide range of stakeholders. Topics that FDA would like to cover in the meeting include whether the scope of the guidelines satisfactorily addresses the particular questions, whether there are issues FDA could or should have addressed and did not, and whether FDA’s thinking on each topic is sufficiently clear to provide meaningful guidance to stakeholders.

Second, FDA is interested in obtaining public input regarding the agency’s priorities for development of future policies regarding biosimilars and whether or not it aligns with stakeholder needs.

The agency is also interested in additional topics that should be considered. Topics currently under consideration for future guidelines include:

  • 351(k) applications seeking a determination of interchangeability
  • requests for reference product exclusivity
  • naming issues
  • clinical pharmacology evaluation of biosimilar products
  • questions and answers regarding Implementation of Biologics Price Competition and Innovation Act of 2009.

Those wishing to present during the public hearing must register by email (biosimilarspublicmtg@fda.hhs.gov) by 11 April 2012, and FDA will accept written comments until 1 May 2012. A live webcast can be viewed at http://www.fda.gov/Drugs/NewsEvents/ucm265628.htm on the day of the hearing, and a recording will be available at the same web address for one year.

Related articles

FDA discusses biosimilars guidance

Interchangeability not covered in FDA draft biosimilar guidance


1.  GaBI Online - Generics and Biosimilars Initiative. FDA finally issues draft biosimilar guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 23]. Available from: www.gabionline.net/Guidelines/FDA-finally-issues-draft-biosimilar-guidance

Source: FDA

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