“We are pleased to see the government of British Columbia add Renflexis to its formulary, which offers effective and more affordable treatment options for patients impacted by these diseases,” Manon Lafontaine, vice president of patient access at Merck Canada, said in a press release. “We’re committed to continuing to work with provinces and territories throughout Canada to ensure broader access for all patients to the care they need.”
Renflexis, which is manufactured by Samsung Bioepis, is a similar, cheaper version of brand-name Remicade. It is marketed and distributed in the U.S. and Canada by Merck, known as MSD outside these countries.
It consists of engineered parts of antibodies that block the naturally occurring pro-inflammatory molecule tumor necrosis factor alpha (TNF-α), which mediates the underlying mechanism of some autoimmune diseases, caused by deregulation of the body’s own immune system resulting in injury to tissues and organs.
For inflammatory bowel diseases, this biosimilar agent is indicated to reduce signs and symptoms of inflammation and achieve stable clinical remission in patients with moderate to severe disease who do not successfully respond to first-line therapy.
In ulcerative colitis, Renflexis can also sustain bowel mucosal healing processes (a measure of clinical activity) and prevent the need for corticosteroids.
Renflexis was approved by the U.S. Food and Drug administration in April 2017, and in Europe and Australia in 2016, as an injectable 100 mg dose for several autoimmune indications, including adult ulcerative colitis and adult, pediatric, and fistulising Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. It is also recommended for the treatment of pediatric Crohn’s disease in patients age 6 or older.
Merck offers eligible patients a comprehensive assistance program to gain access to Renflexis. The Merck HARMONY patient assistance program gives patients additional information and resources about costs and insurance coverage, and may even cover the full cost of treatment if specific financial criteria are met.