Mabion S.A. completes marketing authorisation application for flagship drug, MabionCD20, to the European Medicines Agency (EMA)
- Company submitted the marketing authorisation application under the centralised authorisation procedure which makes it possible to obtain marketing authorisation in all EU states as well as in Island, Norway and Liechtenstein;
- Mabion is first Polish biotech company to successfully complete development of a biosimilar drug independently and to submit an application for European marketing authorisation.
Sławomir Jaros, PhD, CSO, Head of Operations and Science at Mabion S.A.:
Our team has worked for over ten years to submit this dossier to the EMA. It is a historical achievement, because MabionCD20 is the first biotech drug to have been designed and developed from scratch in Poland by a team of Polish scientists. It is also the first such dossier to have been developed in our country. This makes both this program and the people who have created it unique. I strongly believe that achieving this milestone opens up new, extraordinary opportunities, and increases the chances of additional Polish projects appearing on the international arena. For my part, I would like to thank our investors for their support and the team for their perseverance, consistency and trust.
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.
Artur Chabowski, President of the Board, Mabion S.A.: Submitting documentation to the EMA is significant milestone in our partnership and global company, Mylan. We are prepared to work with the European regulator on the this dossier. We will use the EMA review period to retrofit the current plant and expand its production capacity, which will enable us to satisfy the demand of the European market. With Mylan’s continuing support, we are preparing for launch of MabionCD20 onto the European market. We are also looking forward to our upcoming meeting with the FDA and finalizing the most optimal pathway towards registering MabionCD20 in the USA. Furthermore, we are preparing specifications for the MabionMS clinical programme project; the patent for this treatment in Europe, with the option of extension on the global scale, is pending.