Celltrion’s Truxima, a near-copy of Roche’s MabThera, has become the world’s first approved cancer drug biosimilar. 

Having navigated the complex and stringent regulatory process for biosimilars, Truxima is now approved in all of the same disease indications as MabThera, which includes non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia (CLL) as well as inflammatory diseases rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

“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. “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”.

The South Korean pharma company is the first to take advantage of MabThera’s lack of patent – which expired four years ago – to create a potentially far cheaper version of the drug that delivers similar efficacy and safety.

The reason for little competition within that time period has been due to MabThera being an antibody treatment and therefore being particularly difficult to replicate.

The drug has enjoyed its time as a sole option in that sense, raking in more than $7 billion a year for Roche.

Although biosimilars of best-selling drugs are viewed essentially as replacement therapies, how much of an impact Truxima will have on MabThera’s sales remains to be seen. Roche has created a rapid infusion version of the drug which could keep payers interested in its product over a version that, quite literally, just has its lower price going for it.

After success in Europe, Celltrion is also looking to file for approval in the US where its commercial partner for both Truxima and its biosimilar of Roche’s Herceptin, Herzuma, is Teva.

Truxima’s success follows on from its previous FDA approval of its biosimilar Rensima in 2016, a near-copy of MSD’s Remicade.