The European Commision (EC) approved Sandoz’ Rixathon® biosimilar of Roche’s blockbuster monoclonal antibody (mAb) rituximab (MabThera®/Rituxan®). Rixathon is cleared in Europe for use in all MabThera-approved indications, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
“Today's approval of Rixathon represents a big win for patients in Europe with blood cancers or immunological diseases because it enables increased access to biologics,” stated Carol Lynch, global head for Biopharmaceuticals at Sandoz.
Rixathon is the second rituximab biosimilar approved in Europe within the last few months. In February, the EC cleared Celltrion Healthcare’s rituximab copy Truxima™ as the first biosimilar mAb approved in anywhere in the world for a cancer indication.
Clearance of Rixathon in Europe was based on a preclinical and clinical development program to demonstrate that Rixathon matched rituximab's safety, efficacy, and quality. This included the ASSIST-RA study, which demonstrated equivalence in rituximab and Rixathon PK/PD profiles and confirmed there were no differences in safety, tolerability, and immunogenicity between the two drugs in rheumatoid arthritis patients. The Phase III confirmatory ASSIST-FL study demonstrated equivalence in overall response rate between Rixathon and rituximab after six months, and also confirmed comparable safety profiles.
Sandoz is Novartis’ generics and biosimilars unit. The company says it now has four biosimilars approved in Europe, and is planning five major launches over the next four years. Within the last three weeks, the firm reported that the European Medicines Agency (EMA) had accepted for review its marketing authorization applications for biosimilars to AbbVie’s Humira® (adalimumab) and Janssen’s Remicade® (infliximab).
Also within the last couple of months, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on Sandoz’ biosimilar etanercept (Amgen’s and Pfizer’ Enbrel®) biosimilar. A recent GEN report tagged adalimumab as the world’s biggest selling drug in 2016, with sales of $16.078 billion. Enbrel was number three on the global blockbuster list, with combined sales by Amgen and Pfizer of $8.874 billion. Infliximab, at position number five on the top seller's list, achieved combined sales by J&J and Merck of $7.829 billion in 2016.
MabThera/Rituxan is Roche’s biggest selling drug and number four on the list of last year’s top fifteen, with combined sales by Roche and Biogen of $8.583 billion in 2016. Roche reported MabThera/Rituxan sales of CHF 1.9 billion (approximately $1.95 billion) in the first quarter of 2017, up 4% on Q1 2016 sales.