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Nature Reviews Gastroenterology & Hepatology (06/16/2015) Casteele, Niels Vande; Sandborn, William J.

CT-P13, a biosimilar of infliximab, has become the first anti-TNF biosimilar monoclonal antibody (mAb) to be approved in South Korea, Europe, and Canada. There are still uncertainties, however, about indication extrapolation and interchangeability. If anti-TNF mAbs demonstrate bioequivalence and interchangeability in patients with inflammatory bowel disease (IBD), this could achieve savings of 40 percent or more, and could launch a cycle of innovation that is currently limited by the high price of anti-TNF mAbs. To approve a biosimilar, many health agencies require extensive studies on similarity to the reference product in quality, pharmacokinetics, efficacy, safety, and immunogenicity. When studies are performed in only a subset of clinical indications, the sponsor may request extrapolation to all indications held by the innovator. Authorization of a biosimilar is not necessarily a declaration of interchangeability. The medical community is awaiting trial results involving patients with IBD and monitoring of patients who receive CT-P13. Investigators should conduct studies to demonstrate that the pharmacokinetic, immunogenicity, and efficacy are similar, particularly studies to formally assess the safety and efficacy of interchangeability in patients with IBD.

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