Swiss company BioPartners has had its application to market a biosimilar version of interferon alfa turned down by the European Medicines Agency drug advisory committee, in a blow to its ambition of developing a stable of substitutable versions of established biologic drugs.
The EMEA’s Committee on Medicinal Products for Human Use (CHMP) ruled that BioPartner’s Alpheon product could not be approved as a biosimilar version of Roche’s hepatitis drug Roferon A (interferon alfa-2a) because the criteria to prove that the drug could reliably be used in the place of Roche’s drug had not been met.
The Swiss company, which has already been granted EU approval for a biosimilar human growth hormone product called Valtropin, said the CHMP decided that the characterisation, manufacturing and control (CMC) portions of its application for Alpheon fell short of its requirements for approval.
“BioPartners is looking forward to evaluating the EMEA report and with the issues clarified, anticipates being in an even better position for resubmission,” said the company in a statement.
The CHMP said it had major concerns regarding the comparability of Alpheon and Roferon-A, because of differences identified between the two medicines, such as impurities. It also had concerns that there was not enough data on the stability of the active substance and of the medicine that was going to be marketed, and said the process used for making the finished medicine had not been adequately validated.