Samsung’s approval is the first in the US for 2017.

In 2016, the FDA approved four biosimilar drugs, Zarxio, Inflectra, Erelzi and Amsevita in part as a response to growing demand for generic biologic therapies, as well as a desire to lower the price of these type of medicines. It is springtime for this category, with a pipeline that may see five more biosimilars approved.

Among the first is Samsung Bioepis Co., Ltd., with RENFLEXIS(infliximab-abda) biosimilar, referencing Remicade® (infliximab), which was approved by the FDA across all eligible indications.


Samsung’s infliximab biosimilar has been approved for marketing in 28 European Union (EU) member states, including Norway, Liechtenstein, Iceland, Australia and Korea. RENFLEXIS is the first Samsung product approved for marketing in the US and, according to Samsung Bioepis, is indicated for patients with adult and pediatric Crohn’s disease, rheumatoid arthritis, adult ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and to treat adult plaque psoriasis.

On approval, Christopher Hansung Ko, President & CEO of Samsung Bioepis remarked, “Since our company was established five years ago, we have strived day-in and day-out to realize the promise of biosimilars for patients across the United States.”

By offering treatment options at a lower cost, Ko said the company hopes this regulatory milestone will bring it closer to achieving its goal to bring affordable biosimilars to the US. “Through relentless process innovation and an uncompromising commitment to quality, we remain committed to advancing one of the industry's strongest biosimilar pipelines.”