The launch was recently announced by Samsung Bioepis as the company’s first biosimilar approved in the U.S. Renflexis was approved by the U.S. Food and Drug Administration (FDA) in April. Merck will be responsible for commercializing Renflexis in the U.S.
Renflexis is a tumor necrosis factor (TNF) inhibitor indicated for reducing signs and symptoms of ankylosing spondylitis, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis.
TNF is involved in autoimmune and immune-mediated disorders, and is known to play a role in the inflammatory response. TNF blockers are pharmaceuticals that suppress the physiologic response to TNF and are used to treat several autoimmune and inflammatory conditions.
“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, 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,” Ko added.
Samsung Bioepis is also developing a biosimilar product to Humira (adalimumab) called Imraldi (adalimumab). That drug recently received a positive review from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) as a potential treatment for ankylosing spondylitis and other conditions.
Ankylosing spondylitis is a form of arthritis that primarily affects the spine, causing inflammation of the spinal joints (vertebrae). The inflamed vertebrae can lead to ankylosis — new bone formation in the spine — causing sections of the spine to fuse in a fixed, immobile position. This can lead to severe, chronic pain and discomfort.
Inflammation or stiffness can also occur in other areas of the body in patients with ankylosing spondylitis, such as the shoulders, hips, ribs, heels, and small joints of the hands and feet. Sometimes the condition can affect the eyes as well as the lungs and heart.
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