Biosimilar rituximab – many have started – only a few will succeed

The race for the global rituximab market is approaching the finishing line. Mabion S.A., a Polish biotechnology company is among the leaders of the race.

Expiry of the rituximab (MabThera®) patent at the end of 2013 paved the way for the introduction of cheaper versions of the drug by biosimilar manufacturers. Several players, including the largest representatives of the pharmaceutical industry in the world, joined the race to get a piece of the pie – which at that time was worth approx. CHF 7 billion annually1. Currently, given the decision taken by i.a. Boehringer Ingelheim to suspend its clinical trial, market experts agree that only a few companies will stay in the game, and among them the first and only Polish biopharmaceutical company – Mabion S.A.

The fight for the podium

Our current clinical trial program assumes that the last administration of the drug to a patient in the RA trial will be in June 2016 and in the case of the lymphoma trail, in August 2016. After the trials have been completed, we will be ready to submit all documents needed for the registration of a drug – says Maciej Wieczorek, President of the Board in Mabion S.A.

The company regularly consults the progress of its trials with the European Medicines Agency (EMA) as part of the scientific advice procedure.

Maciej Wieczorek: The design of our clinical program, including the particularly important safety study range, was consulted with EMA in the scientific advice process on three separate occasions, each time receiving a positive opinion. We find it is a very significant element of risk reduction in terms of receiving marketing authorisation for MabionCD20.

Additionally, the technological elements used for the manufacture of the drug already at the clinical trial stage demonstrate that we are not only capable of obtaining a drug which is equivalent to the reference drug, but also a drug characterised by a more positive safety profile, which is of utmost importance from the point of view of introducing a therapy into the market, as well as its acceptance by patients and the regulatory authority.

Innovations in the manufacturing technology as the key to success

The company built a modern biotechnology facility in Konstantynów Łódzki to manufacture its drugs. This is the only highly-advanced biotechnology drug production facility in Poland and one of the few in the whole world – says Maciej Wieczorek. Experts agree that it is the only facility for large-scale production of biopharmaceuticals based fully on the disposables technology (eliminating the product's contact with the production environment and the machinery) in 100% of the manufacturing chain. This is largest facility operating in this technology worldwide. The factory is equipped with the world's only sterile product filling line based fully on robotic systems which do not come in contact with the product.

Bound to succeed?

Mabion S.A. intends to register MabionCD20 on markets in all countries where the reference drugs are sold. The entire production process will be located in Poland, in the company's plants, and the sale of the drug will be carried out by foreign partners.

We are currently in talks with several partners, which include companies ready to enter into final trade negotiations. In view of our plans to develop other biosimilars, we find it very important to obtain such a parter or partners for MabionCD20, who will allow us to effectively implement milestones and who will ensure the best conditions for the sale of our drug – says Artur Chabowski, Member of the Board in Mabion S.A.

Mabion S.A. is a leading biotechnology company in Poland, created for the purpose of marketing cutting-edge biotechnological drugs based on humanised monoclonal antibodies. This technology, developed independently in Mabion, meets highest international standards. The process of humanising monoclonal antibodies, which is the pinnacle of modern biotechnology, allows for creation of targeted drugs which act selectively on tumour cells, thus ensuring greater effectiveness and lower toxicity of the therapy. Mabion is one of the few biopharmaceutoical companies with the capacity for comprehensive development and implementation of all kinds of biotechnology drugs – starting with the design stage, through the selection of the platform and manufacturing technology, and ending with the manufacture and obtaining marketing authorisation of the finished drug. Currently, the company conducts research and development works on several biotech drugs used in the treatment of cancers and inflammatory diseases. More information available at:

1 source: Roche Finance Report 2015

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