The U.S. Food and Drug Administration Friday approved Samsung Bioepis’ rheumatoid arthritis biosimilar, allowing the latter to make its first full-fledged entry into U.S. markets since its foundation five years ago, the company said.

Samsung Bioepis_{삼성바이오에피스} (CEO: Ko Han-sung_고한승) has won the FDA approval for Renflexis (compound: infliximab), a cheaper copy of Johnson & Johnson’s blockbuster Remicade biologic 13 months after making an application. Doctors prescribe the drug for patients with Crohn’s disease, adult ulcerative colitis, ankylosing spondylitis, adult plaque psoriasis, psoriatic arthritis, and rheumatic arthritis.

The Korean company hopes to attain significant sales from it, as the biosimilar drug takes over Remicade’s market, which had recorded 9.3 trillion won ($8.1 billion) in sales last year, according to Johnson & Johnson.

Samsung Bioepsis jumped into the biosimilar market in 2012, and has outflanked its competitors by winning the FDA’s approval in 2015 and those of other foreign regulators, such as those in Australia and Europe in 2016, company officials said.

“The FDA approval is one of the most notable achievements of the company since its foundation five years ago. We expect our new drug will provide patients with autoimmune diseases in the United States and Europe with biological treatment,” said CEO Ko Han-sung.

Merck & Co Inc. will market and distribute Renflexis in the American market.

Samsung BioEpis currently sells Brenzys, a biosimilar of Enbrel (etanercept), in Australia, Canada, Korea, and Europe. The company is also undergoing European Medicines Agency’s market authorization process for its HUMIRA and Herceptin biosimilars in Europe.