JointHealth™ express   May 12, 2020

Health Canada Approves the Biosimilar Rituximab (Riximyo)

On April 28, 2020, the biosimilar rituximab (Riximyo) was approved for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.

Riximyo is a biosimilar to the biologic originator, Rituxan. Both contain the same active pharmaceutical ingredient, Rituximab. Health Canada’s approval means that Riximyo has highly similar effectiveness, safety, immunogenicity profile and quality, and delivers the same therapeutic benefits to patients as its biologic originator, Rituxan, which was already approved for sale.

Health Canada states that the manufacturer of Riximyo has demonstrated the pharmacokinetic (the way drugs move within the body) similarity of Riximyo and Rituxan in healthy volunteers. In addition, clinically meaningful differences in safety and efficacy were not seen in a randomized, controlled clinical trial comparing Riximyo to Rituxan. Based on an assessment of all the information provided in the submission, Riximyo is considered to have benefit and risk balances similar to those which have been established for Rituxan.

Riximyo (100 mg/10 mL or 500 mg/50 mL) is presented as a solution for injection in a single-dose pre-filled syringe.

What happens next?

Riximyo is currently under consideration for public reimbursement by the pan-Canadian Pharmaceutical Alliance for public reimbursement on federal, provincial and territorial drug formularies.

ACE will keep you informed about listing decisions as they become known.

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