BEBAC  Ing. Helmut Schütz


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On 9 Feb 2012 the FDA published three draft guidance documents on biosimilar product development to assist industry in developing such products in the US.


Final guidance and quality considerations of April 24, 2017. Q&As: Internet Archive Ref.1 of May 08, 2015, Rev.2 of December 07, 2018.