Mundipharma Establishes Disti License from Celltrion

The Center for Biosimilars Staff

UK-based Mundipharma has made steps towards its goals of becoming a leader in the biosimilars field, it has announced this week. It announced on Tuesday that it had secured a distribution licence from South Korea’s Celltrion for Truxima, a biosimilar of Roche's (ROG: SIX) blockbuster drug MabThera (rituximab). This biosimilar received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use last week for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. These are all of the indications of the reference biologic.

If approved, Truxima would be the first rituximab biosimilar approved by the European Commission. Mundipharma and its network of independent associated companies will have exclusive rights to market and distribute Truxima in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands.

It will be the second biosimilar monoclonal antibody to be marketed and distributed by the Mundipharma network.

The company’s managing director Antony Mattessich said: “Mundipharma is establishing itself as a leader in biosimilars with our deep understanding of European markets and track record in delivering marketing excellence in a complex area.

“Biosimilar rituximab has an enormous potential to deliver patient benefits while freeing up resources for novel cancer treatment options. That’s why biosimilars are becoming a key part of our business in Europe and we look forward to building on our partnership with Celltrion and continuing to identify further partnerships in this area.”