Samsung Bioepis received its first approvement by FDA

| By | Drug Development, Drug Quality Control, FDA

Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS (infliximab-abda), a biosimilar referencing Remicade (infliximab), across all eligible indications. In the US, RENFLEXIS is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis.

RENFLEXIS is the first Samsung Bioepis product approved for marketing in the United States.

“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 them treatment options at a lower cost. We hope this regulatory milestone will bring us a step closer to achieving this goal,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain committed to advancing one of the industry’s strongest biosimilar pipelines.”

“This is a unique opportunity for us to leverage our experience in developing and manufacturing high-quality biologics in therapeutic areas where we are deeply focused, and provide medicines to patients where there is a significant societal need,” said Tony Kingsley, executive vice president of global commercial operations for Biogen Idec. “As a company that aims to make a difference in the lives of patients with serious diseases, we are excited by the potential to offer additional highly effective therapies in critical areas where there is growing demand.”

Samsung Bioepis’ infliximab biosimilar has also been approved for marketing in 28 European Union (EU) member states, Norway, Liechtenstein, Iceland, Australia and Korea.

Samsung Bioepis is responsible for the development and manufacture of all immunology and oncology biosimilar candidates in its pipeline, including RENFLEXIS, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilar candidates.

RENFLEXIS will be marketed and distributed in the US by Merck, which is known as MSD outside of the US and Canada.

SOURCE: samsung bioepis
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