Mundipharma to launch Mabthera biosimilar in EU markets

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Mundipharma is gearing up to launch biosimilar Truxima in seven European markets for the treatment of certain cancers and inflammatory conditions, after Celltrion bagged a regulatory approval for the drug.

The company said that it and its network of independent associated firms will launch Truxima (rituximab) in the UK, Germany, Italy, Netherlands, Belgium, Republic of Ireland and Luxembourg, following authorisation by the European Medicines Agency.
Truxima, now the first biosimilar monoclonal antibody to win approval in Europe for the treatment of cancers including the Non-Hodgkin's lymphomas diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukaemia, is a biosimilar of Roche's blockbuster Mabthera.

In 2015, Mabthera was the world's top selling oncology drug costing healthcare systems more than $7 billion a year.

According to Mundipharma, as Truxima is intended to cost less than its reference product, it is hoped that cost savings from using the biosimilar "will enable access for patients in need of new innovative cancer therapies".

The drug can also be used to treat rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, having demonstrated comparable safety and efficacy to its reference product in clinical trials.

"Assuming the price of biosimilar rituximab is 70 percent compared to reference rituximab, and the market share of biosimilar rituximab is 30 percent (first year), 40 percent (second year) and 50 percent (third year), over this three-year time period the budget savings across the 28 countries of the EU would be around 570 million euros", said Professor László Gulácsi, head of Department of Health Economics, Corvinus University of Budapest.

"This equates to 49,000 new RA, NHL and CLL patients who could be receiving life-changing treatment which is clearly a huge aggregate health-gain at both a national and EU level".

"With our partners across Europe, we will work together to ensure that Truxima is available to the many patients who can benefit from this treatment", said Jung-Jin Seo, chairman of Celltrion Group. "For healthcare systems burdened with high cost oncology treatments, we are pleased to provide an option that has the potential to offer significant savings whilst ensuring patients retain access to high-quality and effective treatments".

"With our global reach, European expertise and proven track record, we are an attractive partner for any companies looking to commercialise biosimilars in Europe and are looking forward to further expand our portfolio in this complex and rapidly growing area," added Antony Mattessich, managing director of Mundipharma International.

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