Mabion SA, the Polish biopharmaceutical company that develops new generation of biosimilar drugs, is one step closer to releasing its MabionCD20 drug in Argentina. Together with the intermediary company LKM SA, a petition was submitted in Argentina for approval to start the registration procedure of MabionCD20, a drug used in the treatment of blood cancers and rheumatoid arthritis (RA). All the required research and legal documentation was submitted to the Argentine Ministry of Health the central body responsible for registration of drug products as well as for marketing authorisation.
LKM SA is a partner of Mabion for registration and future sales of MabionCD20 in the following markets: Argentina, Venezuela, Peru, Chile, Uruguay, Ecuador, Colombia, Bolivia and Paraguay.
The documentation submitted by LKM SA includes a characteristics comparison of MabionCD20 with the reference drug MabThera; technological, analytical and qualitative documentation; the results of laboratory tests; and the effects of tests conducted on animals. The documentation does not include the clinical module (the results of clinical trials) and consequently can not currently provide the basis for the registration of the MabionCD20 drug. The data currently available is only sufficient to initiate the registration procedure. The documentation will be regularly updated with additional data as they are obtained by the company.
“Work on the MabionCD20 drug is already at a very advanced stage we are concluding phase III of clinical trials. Argentina is the latest country in which our drug’s registration procedure is underway. We are successively executing our plan to register and release the drug on markets with less stringent registration regulations. The submission of a preliminary version of the registration dossier will allow the Argentine Ministry of Health to familiarise itself with the drug during clinical trials, evaluation will then only require conclusion of the clinical module. The documentation submitted does not provide a basis for registration of the drug but, in our opinion, will accelerate the procedure by up to several months” says Maciej Wieczorek, chief executive officer, of Mabion SA.
In regard to regions with less restrictive registration systems, such as Africa or Asia, Mabion SA is planning both the implementation of sales, and the entire registration procedure, in cooperation with leading local pharmaceutical companies. Production will take place in Mabion’s Scientific-Industrial Biotechnological Complex in Poland, and the company will have shares in revenue from the sale of drugs by foreign distributors. So far, Mabion has signed. An agreement with the pharmaceutical company LYFIS for Iceland. An agreement with the Ukrainian pharmaceutical company Farmak for Ukraine, Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan and Uzbekistan. An agreement with the Turkish pharmaceutical company ONKO for Turkey. An agreement with the Moroccan pharmaceutical company Sothema Laboratories for the North African countries Morocco, Algeria and Tunisia. An agreement with the Argentine pharmaceutical company LKM SA for the South American countries Argentina, Colombia, Venezuela, Peru, Chile, Paraguay, Ecuador, Bolivia and Uruguay.
A letter of intent with a pharmaceutical company from Lebanon in relation to the Middle East. A letter of intent with a pharmaceutical company from Croatia in relation to the Balkan countries.