Three more biosimilar versions of the monoclonal antibody rituximab have been recommended for approval in Europe, having been found to be "highly similar" to the reference product, rituximab (MabThera, Roche).
The recommendations for approval were made by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
The three new products are Blitzima, Tuxella, and Ritemvia , all marketed by Celltrion Healthcare Hungary Kft.
Last month, two biosimilar rituximabs were recommended for approval in Europe: Rixathon and Riximyo (both from Sandoz).
Rituximab, first launched in Europe in 1998, has become a backbone of treatment for non-Hodgkin's lymphoma (NHL) and is also used in chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and granulomatosis with polyangiitis and microscopic polyangiitis (GPA&MPA).
The biosimilar Ritemvia has all four indications, while the biosimilar Riximyo has three of the four indications; the exception is CLL.
The new biosimilar products Blitzima and Tuxella also have three of the fours indications — NHL, CLL, and GPA&MPA — but not RA.
The new biosimilar Ritemvia has only two of the four indications: NHL and GPA&MPA.
ESMO Enthusiastic About Biosimilars
European oncologists have been enthusiastic about the coming of biosimilars. The main attraction is their potential to lower costs.
In a position paper released earlier this year, the European Society for Medical Oncology (ESMO) said that price discounts for biosimilars of 20% to 40% could be reached in Europe, with potential savings for healthcare systems of €50 billion to €100 billion ($53 billion to $107 billion) by 2020.
"Biosimilars are an excellent opportunity to have good, valid drug options that improve the sustainability and affordability of cancer treatment in various countries," Professor Josep Tabernero, MD, PhD, chair of the ESMO Cancer Medicines Working Group, from the Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Spain, commented in a statement at the time.