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FDA Approves Renflexis

FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda), a biosimilar referencing Remicade®i (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 (US).

“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.”

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.

About Renflexis

Renflexis is a tumor necrosis factor (TNF) blocker approved in the U.S. for the following indications.

  • Crohn’s Disease – Renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Renflexis is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease.
  • Pediatric Crohn’s Disease Renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
  • Ulcerative Colitis Renflexis is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
  • Rheumatoid Arthritis Renflexis, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.
  • Ankylosing Spondylitis Renflexis is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
  • Psoriatic Arthritis Renflexis is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.
  • Plaque Psoriasis Renflexis is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. Renflexis should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

i Remicade® is a registered trademark of Janssen Biotech Inc.

Source: Samsung Bioepis Co., Ltd.

Posted: April 2017

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