FDA OKs Samsung Bioepis’ Biosimilar to J&J’s Top-Selling Remicade

Samsung Bioepis, an Incheon, South Korea-headquartered biopharmaceutical company that is a joint venture between Samsung BioLogics and Biogen, has received approval from the US Food and Drug Administration (FDA) for Renflexis (infliximab-abda), a biosimilar referencing Johnson & Johnson’s (J&J) blockbuster drug, Remicade (infliximab), across all eligible indications. Remicade is the top-selling drug in J&J’s pharmaceuticals division with 2016 sales of $6.97 billion.

Samsung Bioepis’ infliximab biosimilar has also been approved for marketing in 28 European Union (EU) member states as well as in Norway, Liechtenstein, Iceland, Australia, and Korea. Samsung Bioepis is responsible for the development and manufacture of Renflexis as well as all immunology and oncology biosimilar candidates in its pipeline. The company is also responsible for 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 & Co.

In the US, Renflexis, a tumor necrosis factor blocker, is indicated for treating Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and adult plaque psoriasis.

Source: Samsung Bioepis

*Editor’s note: Sales of Remicade were updated to $6.97 billion.

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