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Mundipharma to launch first MabThera biosimilar in EU

EMA approves Truxima in all indications licensed to Roche’s cancer drug

EMAThe European Medicines Agency has approved MabThera (rituximab) biosimilar Truxima for use in all of the cancer blockbuster's licensed indications, becoming the first copycat of its kind to win regulatory approval.

Developed by South Korean biosimilar specialist Celltrion Healthcare, Truxima is set to be launched in the UK, Germany, Italy, the Netherlands, Belgium, Ireland and Luxembourg by UK-based pharma network Mundipharma.

It showed comparable preclinical, safety and efficacy data to Roche's monoclonal antibody, and is licensed for the treatment of chronic lymphocytic lymphoma (CLL) - for which MabThera is widely used - as well as non-Hodgkin's follicular lymphoma and diffuse large B-cell lymphoma.

The biosimilar has also been approved for use in adults with severe rheumatoid arthritis and in combination with glucocorticoids for the treatment of granulomatosis with poylangiitis and micropscopic polyangiitis.

Since its first authorisation in the US in 1997, followed a year later by EU approval, MabThera has become a $7bn brand for Roche, and was the world's biggest-selling cancer drug in 2015.

Roche's blockbuster even saw slight growth in 2016, despite increasing competition and pricing pressure, but the firm hopes to combat the advent of biosimilars with a flurry of new launches in the coming year, including lung cancer drug Alecensa (alectinib) and multiple sclerosis treatment Ocrevus (ocrelizumab).

Though no price listing has been made available for Truxima as of yet, Mundipharma has stated that it hopes funding saved by using the biosimilar “will enable access for patients in need of new innovative cancer therapies”.

Truxima is not the first biosimilar Mundipharma has licensed for EU marketing, having launched Remsima, a biosimilar version of Janssen's blockbuster arthritis treatment Remicade (infliximab), in 2015.

Article by
Rebecca Clifford

23rd February 2017

From: Regulatory

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