ARTICLE | Regulation
Biosimilar can of worms
July 18, 2005 7:00 AM UTC
With last month's publication of draft guidelines on biosimilar EPO and G-CSF, the EMEA has now proposed requirements for four recombinant proteins - draft guidances on insulin and somatropin were published in May, as was an overarching guidance on biosimilars. The stage is now set for the first Europe-wide approval of a biosimilar protein, which will inevitably lead to a legal showdown between innovator and biogeneric companies.
The first battle will be over the wording of all the drafts, which remain rife with ambiguities. ...