First US approval for Samsung Bioepis

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The U.S. Food and Drug Administration has approved the biosimilar product infliximab-abda across all eligible indications. It will be marketed and distributed in the US by Merck. The product has also been approved for marketing in 28 European Union (EU) member states, Norway, Liechtenstein, Iceland, Australia and Korea. The drug 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. Samsung Bioepis is responsible for the development and manufacture of all immunology and oncology biosimilar candidates in its pipeline, as well as global clinical trials and regulatory registration in all markets worldwide for these candidates.

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