JointHealth™ express October 6, 2016
Health Canada approves biosimilar etanercept for rheumatoid arthritis and ankylosing spondylitis
What does this mean for patients?
On August 31, 2016, the biosimilar etanercept (BRENZYS) was approved for the treatment of rheumatoid arthritis and ankylosing spondylitis.
BRENZYS is a subsequent entry biologic (biosimilar) to the Canadian authorized reference product, Enbrel. Both contain the active pharmaceutical ingredient, etanercept.
Health Canada states that the applicant has demonstrated the pharmacokinetic (the way drugs move within the body) similarity of BRENZYS and Enbrel in healthy volunteers. In addition, clinically meaningful differences in safety and efficacy were not seen in a randomized, controlled clinical trial comparing BRENZYS to Enbrel in patients with moderate to severe rheumatoid arthritis. Based on an assessment of all the information provided in the submission, BRENZYS is considered to have benefit and risk balances similar to those which have been established for the reference product, Enbrel.
Please click here to read the details of Health Canada’s decision summary for BRENZYS.
What happens next?
BRENZYS will now be evaluated for its cost effectiveness to the health care system by CADTH. They will make a listing recommendation to federal, provincial and territorially drug formularies, and each one will then determine its placement on their formulary.
ACE will keep you informed about listing decisions as they become known.
Health Canada approves biosimilar etanercept for rheumatoid arthritis and ankylosing spondylitis
What does this mean for patients?
On August 31, 2016, the biosimilar etanercept (BRENZYS) was approved for the treatment of rheumatoid arthritis and ankylosing spondylitis.
BRENZYS is a subsequent entry biologic (biosimilar) to the Canadian authorized reference product, Enbrel. Both contain the active pharmaceutical ingredient, etanercept.
Health Canada states that the applicant has demonstrated the pharmacokinetic (the way drugs move within the body) similarity of BRENZYS and Enbrel in healthy volunteers. In addition, clinically meaningful differences in safety and efficacy were not seen in a randomized, controlled clinical trial comparing BRENZYS to Enbrel in patients with moderate to severe rheumatoid arthritis. Based on an assessment of all the information provided in the submission, BRENZYS is considered to have benefit and risk balances similar to those which have been established for the reference product, Enbrel.
Please click here to read the details of Health Canada’s decision summary for BRENZYS.
What happens next?
BRENZYS will now be evaluated for its cost effectiveness to the health care system by CADTH. They will make a listing recommendation to federal, provincial and territorially drug formularies, and each one will then determine its placement on their formulary.
ACE will keep you informed about listing decisions as they become known.
Arthritis Consumer Experts
ACE thanks Arthritis Research Canada (ARC) for its scientific review of ACE and JointHealth™ information and education programs.