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Opinion
Biosimilars: what's around the corner?
  1. Richard K Russell1,
  2. Peter Irving2,
  3. Chris Probert3
  1. 1Department of Paediatric Gastroenterology, The Royal Hospital for Children Glasgow, Glasgow, UK
  2. 2Department of Gastroenterology, Guy's and St Thomas’ NHS Foundation Trust, London, UK
  3. 3Gastroenterology Research Unit, Institute of Translational Medicine, University of Liverpool, Liverpool, UK
  1. Correspondence to Dr Richard K Russell, Department of Paediatric Gastroenterology, The Royal Hospital for Children Glasgow, 1345 Govan Road, Glasgow 51 4TF, UK; richardrussell{at}nhs.net

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Infliximab is an effective treatment for patients with refractory inflammatory bowel disease (IBD) and is well established in treatment algorithms. Biosimilar infliximab will become available in the UK from early 2015 as the patent for originator infliximab (Remicade) ends. Potentially this is a time of uncertainty for IBD teams and patients as, although biosimilar infliximab is approved for the same indications as the originator product, there is a lack of high-quality data supporting its use in IBD. The attraction of biosimilars is that they will result in a significant reduction in the price of infliximab which it is hoped will ease patient access to anti-tumour necrosis factor (TNF) therapy.

Biologics are medications that are manufactured in or derived from a biological product. A biosimilar is a medicinal product based on the same design as a biological drug. However, the production of biosimilars is vastly more complicated than that of simple generic molecules and, as a result, biosimilars must meet strict specifications regarding their efficacy and safety laid down by regulatory authorities such as the FDA and EMA (box 1).

Box 1

Definitions of a biosimilar from the FDA and EMA

FDA definition:

  • Highly similar to the reference product notwithstanding minor differences in clinically inactive compounds. No clinically meaningful differences between the biological product and reference product in terms of safety, purity and potency.

EMA definition: …

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