Biosimilar can of worms
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.
The draft guidances on biosimilar erythropoietin and granulocyte-colony stimulating factor describe the necessary trials and data that biosimilar manufacturers have to submit, as well as the pharmacovigilance requirements once the products are on the market. However, innovator companies and attorneys contacted by BioCentury say many technical requirements haven't been addressed or remain ambiguous.
For example, the guidances appear to allow for an extension of a biosimilar's approval in the first indication to all indications in which the originator products are approved, without the biosimilar manufacturer having to conduct additional trials. Nor do they provide any clue whether the biosimilar versions will be regarded as fully interchangeable with all branded products in the class or whether they can only substitute for the comparator product used in the trials.
As a result, every player in the field is now carefully looking at the details of the proposals. And while the innovators say they do not see their positions reflected in the draft at all, the generics industry is keeping a low profile.
Few players on either side are talking for the record, as all want to discuss their issues with EMEA behind closed doors. However, there seems to be a consensus that the agency should host an open workshop to exchange ideas before the comment period closes at the end of October.
EMEA has not said whether