BEBAC   Ing. Helmut Schütz

FDA

Draft Biosimilar Guidances

On 9 Feb 2012 the FDA published three draft guidance documents on biosimilar product development to assist industry in developing such products in the US.


Update

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.’ 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.