Abstract

A study establishing that the therapeutic equivalence of rituximab biosimilar could lead to annual savings of €150 million and provide access for an additional 12,000 patients with B-cell lymphoma

Article title: Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial

Citation: Ogura M et al. Lancet Haematol. 2018;5;e543-e553

Publication date: November 2018

Widespread adoption of a rituximab biosimilar could have substantial positive effects both on healthcare budgets and at a societal level.

Rituximab is a monoclonal antibody that binds to CD20 protein on the surface of normal and malignant B cells, inducing their immune-mediated destruction. It is used to treat B-cell lymphomas including follicular lymphoma. Like all biologics against cancer, rituximab is associated with high treatment prices. Conversely, biosimilars are generally priced at a 20–30% discount relative to originator products, and their higher affordability implies that more patients can receive these treatments. CT-P10 (Truxima®) is the first approved biosimilar of rituximab, with identical structural and physicochemical attributes and biological activity, and licensed for the same indications. This phase III study aimed to establish the therapeutic equivalence of CT-P10 and rituximab in patients with newly diagnosed CD20-positive follicular lymphoma.

Findings

Over the 7-month observation period, an overall response was seen in 83% patients treated with CT-P10 and 81% of those receiving rituximab, suggesting therapeutic equivalence between the two groups. A similar frequency of treatment-emergent adverse events was reported for CT-P10 and rituximab – most of these were infusion-related reactions. There were no new, unexpected safety findings.

Biosimilar CT-P10 exerts therapeutic equivalence to rituximab in patients with follicular lymphoma. With one budget impact analysis suggesting the introduction of rituximab biosimilar may save healthcare systems in the EU up to €150 million per annum, the availability of CT-P10 is expected greatly to improve patient access to this revolutionary treatment.

Key takeaway

Biosimilar CT-P10 exerts therapeutic equivalence to rituximab in patients with follicular lymphoma. With one budget impact analysis suggesting the introduction of rituximab biosimilar may save healthcare systems in the EU up to €150 million per annum,the availability of CT-P10 is expected greatly to improve patient access to this revolutionary treatment.