celltrion

First biosimilar for European cancer treatment given approval

pharmafile | February 23, 2017 | News story | Sales and Marketing biosimilar, celltrion 

The first biosimilar will be made available in Europe to match the indications of Roche’s best-selling cancer drug, Rituxan. The biosimilar, named Truxima, has been produced by Celltrion, the South Korea-based biopharmaceutical company, and will be made available to patients suffering from non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

Rituxan generated sales of more than $7 billion globally last year and the introduction to the European market of its first biosimilar will check any growth in that figure. Sales figures had increased by 3% in 2016 so the news of Truxima’s approval will be a blow to Roche.

“We are excited to offer the first biosimilar mAb in oncology. 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, speaking at a meeting of their European partners in Paris. “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”.

There is an expectation that Truxima will enter the market with a potential 30% reduction on the price of Rituxan. It will therefore represent a major reduction of price for governments Europe-wide and could likely see Truxima have a rapid uptake, with the press release from Celltrion suggesting a 30% uptake, compared to Rituxan, in the first year of commercial release.

This is not the only biosimilar that Celltrion has on its books, it is currently also seeking EMA approval for its drug, Herzuma – a biosimilar of Roche’s Herceptin. Celltrion will be hoping it can join Truxima and its first biosimilar approval, Remsima (a biosimilar to Remicade), in entering the market.

Ben Hargreaves

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