Pfizer has bagged European approval for Ruxience (rituximab), a monoclonal antibody (mAb) and biosimilar to MabThera (rituximab).
The approval allows for the drug’s use to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and pemphigus vulgaris (PV).
The decision rides on a package of data showing the its biosimilarity to MabThera, including results from the REFLECTIONS B3281006 clinical comparative study, which assessed the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of Ruxience and “found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumour burden follicular lymphoma,” Pfizer said.
“The approval of biosimilars such as Ruxience is an important development for the treatment of certain cancers and autoimmune conditions,” noted Igor Aurer, Professor of Medicine and Head of Haematology Division, University Hospital Centre Zagreb, Croatia. “It’s a step toward allowing clinicians an additional treatment option which can help improve access for patients in need of this established medicine.”
“Biosimilars like Ruxience exhibit a similar safety and efficacy profile to the originator product and have the potential to improve treatment access while reducing healthcare costs,” added Masum Hossain, regional president, Oncology International Developed Markets at Pfizer.