Samsung Bioepis will launch its autoimmune disease biosimilar Renflexis (infliximab-abda) in the United States, the company said Tuesday.
The U.S. market debut comes only three months after the Food and Drug Administration approved it, made possible through a U.S. Supreme Court ruling on biosimilars in June, which eliminated the need to wait 180 days after getting FDA approval to commercialize a product.
Merck & Co, known as MSD outside of the U.S., will handle the U.S. launch of the biosimilar.
Renflexis is a copy drug of the originator biologic Remicade (ingredient: infliximab), developed by Johnson & Johnson. The two companies are currently locked in a patent dispute with industry experts citing it as an effort by Johnson & Johnson’s to delay the biosimilar’s market entry.
Johnson & Johnson’s Remicade is currently earning revenues exceeding $72 billion and is the market leader for infliximab products, according to Bloomberg.
Merck & Co noted that Renflexis would be listed at $753.39, indicating a 35 percent discount on Remicade’s list price. Industry experts predict Johnson & Jonson will face sales erosion from the introduction of the biosimilar.
“The launch of Renflexis puts Samsung Bioepis삼성바이오에피스 on the global stage with global multinational pharmaceuticals as one of the world’s best,” CEO Ko Han-sung고한승 said. “We expect that following Europe, more and more U.S. patients will benefit from biosimilar drug treatments.”
Biosimilars are used to treat many diseases, including rheumatoid arthritis, ulcerative colitis, Crohn's disease, and ankylosing spondylitis. They also have indications for psoriatic arthritis and psoriasis.
Samsung is currently selling Brenzys (reference product: Enbrel) in Australia, Canada, Korea and Europe. Also, the company’s Humira (ingredient: adalimumab) biosimilar Imraldi has received positive marks from the European Medicines Agency in June and is waiting to win rights to sell in Europe. Herceptin biosimilar is also under review for marketing authorization by the EMA.
The company recorded sales of 63.2 billion won ($56.5 million) and operating profit of 8.5 billion in the second quarter of 2017.