First Rituxan biosimilar Truxima set to make its debut in US

Roche Rituxan approval

Biosimilar competition to Roche’s big-selling Rituxan has arrived in the US, with Teva gearing up to launch its Truxima rival at a 10% discount following FDA approval.

Truxima – originally developed by South Korea’s Celltrion – is due to launch next week (11 November) with a wholesale acquisition cost of $845.55 for a 100mg vial and 4,227.75 for a 500mg vial, ahead of any discounts or rebates.

It is the first Rituxan (rituximab) biosimilar in the US with a “full oncology label”, including  the treatment of adult patients with non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL), said Teva.

The FDA approved Truxima for NHL and CLL last November, a few months before the US regulator also cleared a second biosimilar from Pfizer called Ruxience.

Celltrion and Teva – which partners the drug in the US and Canada – held off launching their product before a date agreed by Roche, while Pfizer has indicated it does not intend to launch its biosimilar until January 2020.

Under the agreement with Roche, Celltrion and Teva will also not launch Truxima for Rituxan’s other approved indications in the US – rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA) – until the second quarter of 2020.

Truxima hasn’t been filed for approval in those non-oncology indications however, while Ruxience has been cleared for NHL and CLL as well as GPA and MPA.

Truxima was also the first biosimilar rituximab product to be approved in Europe, where Rituxan is sold under the MabThera brand name. It was launched by Celltrion in Europe under four brand names in 2017– four years after the patent on Roche’s drug expired – and has since been joined by another biosimilar from Novartis’ Sandoz unit.

If the European pattern is followed in the US, Roche is heading for a bumpy ride with its product.

Sales of MabThera have gone into steep decline since biosimilars arrived in Europe, dropping 47% in 2018 and another 33% in the first nine months of 2019 to CHF 470 million (around $473 million).

For comparison, sales of Rituxan in the US gained 4% to CHF 3.39 billion ($3.35 billion) in the first three quarters of the year, ahead of any direct biosimilar competition.

It’s worth noting as well that the European shrinkage came despite Roche’s attempt to protect its product with the launch of a more convenient subcutaneous formulation that cuts the infusion time from several hours to a few minutes.