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Biz News Korea(Eng)
U.S. FDA accepts to review license for Samsung Bioepis’ Remicade copycat drug
- Collected
- 2016.05.25
- Distributed
- 2016.05.27
- Source
- Go Direct
If approved, Samsung Biopeis in partnership with Merck would be able to sell cheaper copycat version of Remicade, exclusive label under Johnson & Johnson whose marketing exclusivity has expired. The medication is used for serious inflammatory diseases like rheumatoid arthritis, ulcerative colitis, Crohn`s disease, ankylosing spondylitis, psoriatic arthritis and psoriasis. Remicade last year sold about $7.6 billion worth.
Korea emerged as a potential power in biosimliars whose demand is growing sharply as low-cost alternatives to expensive drugs. Celltrion Inc. last month won FDA approval to sell Remsima, its first antibody biosimilar. Prescription on Remsima could be possible from October. Since review usually takes a year, Samsung’s infliximab drug will be available from late 2017 or early 2018.
Samsung Bioepis currently sells another biosimilar Brenzys to treat autoimmune diseases in Korea and Europe. The biosimilar is sold as Benepali in Europe. The company’s SB5, biosimilar of Humira for the treatment of several diseases including rheumatoid arthritis, SB3, biosimilar of Herceptin for the treatment of metastatic breast cancer, and SB8, biosimilar of Avastin for the treatment of brain tumors and cancers of the kidney, colon, rectum, or lung, are undergoing the third phase of clinical trials. Its SB9, biosimilar of Lantus, long-acting basal insulin analogue, jointly invested with Merck & Co, is under license review by the European Medicines Agency (EMA).
By Shin Chan-ok
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