Truxima, world's first cancer drug biosimilar approved in Europe

Roche’s cancer and inflammatory diseases drug, MabThera (rituximab), finally faces biosimilar competition in Europe, four years after its patent expired.

The Swiss pharma has enjoyed several extra competition-free years with its best-selling drug, which brings in global revenues of more than $7 billion a year, as monoclonal antibodies are much more difficult to copy than conventional generic drugs.

South Korea’s Celltrion has managed to get its near-copy of MabThera - to be called Truxima - through the rigorous regulatory process for biosimilars, showing that it is as safe and effective as the originator.

But it remains to be seen how much market share the biosimilar will get, as Roche has shrewdly protected MabThera with a more convenient subcutaneous formulation that cuts the infusion time from several hours to a few minutes.

Celltrion’s biosimilar does not have this advantage, and will instead have to rely on price alone to win over prescribers and patients.

Celltrion is also preparing for a US filing and has selected Teva as its commercial partner for the US and Canada for Truxima, and its biosimilar of Roche’s breast cancer drug, Herceptin (trastuzumab).

Mundipharma has distribution rights in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands.

Following backing from the CHMP scientific committee in December, Truxima has been approved in all MabThera’s indications, including non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis and granulomatosis with polyangiitis and microscopic polyangiitis.

In its press statement, Celltrion cited data from professor Laszlo Gulacsi, head of the department of health economics at Corvinus University of Budapest, who said the drug could save 570 million euros from budgets across the 28 member states over the next three years.

This assumed a 30% discount from MabThera’s price and market share of 30% in the first year, 40% in the second year and 50% in the third year.

Celltrion is one of a group of companies that are developing biosimilars of big-selling biologic drugs. It was the first to get a biosimilar monoclonal antibody approved in Europe, with its near-copy of MSD's Remicade (infliximab) inflammatory diseases drug.