The Committee on Medicinal Products for Human Use (CHMP)’s ruling was based on questions concerning characterization, manufacturing and control and biosimilarity that have not yet been resolved to the extent the CHMP believes necessary for a biosimilar.
Attempting to look on the bright side, BioPartners said in a statement that it is looking forward to evaluating the European regulator’s report and resubmitting its application once the issues have been addressed.
To date Switzerland-headquartered BioPartners has submitted two products to the European Medicines Agency (EMEA), namely Alpheon and Valtropin, which recently received marketing authorization for the European Union. The company also has two products in phase III clinical trials.