How much evidence is provided prior to approval? An updated systematic review of biosimilar applications in Europe.

http://www.ideas-itn.eu/wp-content/uploads/2018/06/Johanna_Biosimilars_Forum_Oct_2017.pdf

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Joahnna Mielke, Byron Jones, Franz Koenig, Bernd Jilma. 2nd Annual Biosmiliars Forum, October 2017, Budapest