Health Canada has expanded the approved use of Brenzys, a biosimilar of Enbrel (etanercept), to include the treatment of juvenile idiopathic arthritis (JIA) and other inflammatory disorders.
Brenzys is now indicated to treat signs and symptoms of moderate-to-severe JIA in patients ages 4 to 17, who had an inadequate response to one or more disease-modifying antirheumatic drugs.
“Brenzys adds to Merck’s portfolio of treatments for dermatological and inflammatory immune diseases and can help improve quality of life for patients living with psoriasis, psoriatic arthritis or juvenile idiopathic arthritis, as well as rheumatoid arthritis and ankylosing spondylitis,” Anna Van Acker, president of Merck Canada, said in a press release.
Besides JIA, Brenzys can now also treat patients 4 and older with plaque psoriasis who are candidates for
systemic therapy or phototherapy, as well as adults with psoriatic arthritis to improve physical function, ease symptoms and block structural damage of active arthritis.
The therapy was initially approved in Canada in 2016 for the treatment of moderate-to-severe rheumatoid arthritis and ankylosing spondylitis.
Brenzys is manufactured by Merck, known as MSD outside of the U.S. and Canada.
The decision to expand Brenzys’ indications was based on its similar quality, safety, and efficacy to Amgen‘s Enbrel in patients with rheumatoid arthritis. No clinical trials have been conducted to compare Brenzys to Enbrel in people with JIA, Merck said.
The therapy is a biosimilar of Enbrel. Biosimilars have similar properties, safety, and efficacy as reference biological treatments. Like generics of synthetic medications, biosimilars are intended to lower healthcare costs and provide access to more treatment options.
Both Enbrel and Brenzys work by blocking the pro-inflammatory protein tumor necrosis factor, which has been implicated in JIA and other disorders. As such, these therapies are intended to lower inflammation, pain, and joint damage.
Three Enbrel biosimilars are already approved to treat JIA in Europe: Nepexto, from Mylan and Lupin; Erelzi, from Sandoz, part of Novartis; and Benepali from Samsung Bioepis. Erelzi and Benepali (as Eticovo) are also approved in the U.S.
Brenzys is given by an injection under the skin, and should be administered under the supervision of a physician, according to Merck.