BioCentury
ARTICLE | Politics & Policy

Final EMA guidelines on biosimilars for two therapeutic classes

March 7, 2013 2:04 AM UTC

EMA published final guidelines on Wednesday on the development of biosimilar versions of two classes of therapeutics, including guidelines on the development of multiple sclerosis (MS) drug interferon (IFN) beta that is in line with a 2012 draft. The final (see BioCentury Extra, Jan. 19, 2012).

The agency also published final guidelines on biosimilar products containing recombinant human follicle stimulating hormone (r-hFSH), which is used in assisted reproductive technologies to stimulate growth and recruitment of ovarian follicles and to induce and maintain spermatogenesis. The guidelines outline non-clinical and clinical requirements, including comparative in vitro and in vivo studies, and also note that a double-blind trial efficacy trial is required. ...