New drug Renflexis (infliximab-abda), a therapy for ulcerative colitis and Crohn’s disease, is being launched in the U.S., South Korea’s Samsung Bioepis recently announced.
Renflexis is a biosimilar of the anti-inflammatory drug Remicade (infliximab) and is being commercialized in the U.S. by Merck.
Biosimilars are therapies with no clinically relevant differences to a biological reference product previously approved by the U.S. Food and Drug Administration (FDA). They present almost identical structure and activity to the reference product, and can be produced when the original product’s patent expires.
Renflexis was approved by the FDA in April 2017 as an injectable 100 mg dose to treat a number of autoimmune diseases (where the body’s immune system attacks healthy cells), including ulcerative colitis and Crohn’s disease. Renflexis may also be used by people with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
For Crohn’s disease and ulcerative colitis, Renflexis is indicated to reduce signs and symptoms and achieve stable clinical remission in adult patients with moderate to severe disease who do not show successful response to conventional therapy.
Renflexis taken for ulcerative colitis also aims to maintain mucosal healing (a measure of clinical activity) and eliminate corticosteroid use. Renflexis is also recommended for pediatric Crohn’s disease in patients age 6 and older.
Similar to Remicade, Renflexis consists of synthetically produced parts of antibodies. Both drugs block the naturally produced pro-inflammatory molecule tumor necrosis factor alpha (TNF-α), which is elevated in patients with some autoimmune diseases.
“Since we were established five years ago, we have strived to bring high-quality treatment options at a lower cost to U.S. patients. Renflexis is our first step in meeting this important commitment,” Christopher Hansung Ko, PhD, president and CEO of Samsung Bioepis, said in a press release.
“We firmly believe biosimilars will play an instrumental role in making healthcare more accessible to patients across the U.S., and we will continue our relentless drive to advance one of the industry’s strongest pipelines,” he added.
Renflexis will be introduced in the U.S. at a wholesale acquisition cost of $753.39, which is 35 percent less than Remicade, according to Samsung Bioepis. This price does not include potential additional discounts.
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