INTESTINE Vol.20 No.2(11)

Theme The frontline of Crohn's disease treatment
Title Biosimilar for IBD
Publish Date 2016/03
Author Hideki Iijima Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine,
Author Shuko Iwatani Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine,
Author Toshio Yamaguchi Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine,
Author Manabu Araki Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine,
Author Shoichiro Kawai Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine,
Author Satoshi Hiyama Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine,
Author Shinichiro Shinzaki Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine,
Author Tetsuo Takehara Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine,
[ Summary ] Biosimilars have been developed due to the expiration of patents protecting biological drugs. Biosimilars cannot be considered as mere copies of the original reference drugs, because biologics are produced through complicated steps using living organisms. Additionally, because of post-translational modifications, such as oligosaccharide modifications, biosimilars can be affected by the drug production process. Once a biosimilar has been approved for use in a given indication, such as rheumatoid arthritis, efficacy and safety data are extrapolated to other indications approved for the reference drug, such as inflammatory bowel disease (IBD). Although data for biosimilars in IBD are insufficient, there are some studies showing similar efficacy and safety profile for biosimilars as for the reference drugs.
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