Posted by Michael Wonder on 05 Jun 2018
Mabion completes marketing authorisation application for flagship drug, MabionCD20, to the EMA
5 June 2018 - • Mabion is first Polish biotech company to successfully complete development of a biosimilar drug independently and to submit an application for European marketing authorisation.
Results of the clinical trial carried out on MabionCD20 confirmed that the drug is equivalent to its reference drug, MabThera, in a trial conducted on RA patients and on patients with non-Hodgkin's lymphoma. The results obtained in the trial had been included in the marketing authorisation application, which has just been submitted to the EMA.
