South Korean biotechnology company Celltrion gained approval by the European Medicines Agency (EMA) for the world’s first monoclonal antibody biosimilar Remsima/Inflectra in September 2013 as part of a collaboration with US-based generics company Hospira [1]. Double-blind randomized clinical trials involving 856 patients with active rheumatoid arthritis or ankylosing spondilitis formed part of the comparability exercise between Remsima and Remicade, the results of which contributed to the conclusion that all major physicochemical characteristics and biological activities of the biosimilar were comparable to the originator.

As a result, Remsima was approved for the same indications as its originator, Remicade, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult and paediatric Crohn’s disease and adult and paediatric ulcerative colitis.

A recent survey of members of the European Crohn’s and Colitis Organisation (ECCO) found that most of those surveyed (63.7%) said that they would not switch a patient onto a biosimilar monoclonal antibody (mAb) as there is no disease-specific evidence about their interchangeability. Only 5.9% said that they would switch the patient, with 22.1% saying that they would only switch after informing the patient in detail, ‘because of the limited data on the safety of the biosimilar’ [2].

The infliximab biosimilar was filed with the US Food and Drug Administration (FDA) at the beginning of August 2014, with Celltrion saying that it expects Remsima to become the first biosimilar of a monoclonal antibody drug ever approved in the US, with FDA approval expected by early 2015 [3].

J&J extended the brand-name product’s patent protection in the UK and most EU markets until the end of February, so Mundipharma will be unable to market the biosimilar before then. Remsima will be distributed in the UK by the Mundipharma associated company Napp Pharmaceuticals.

In June 2013, a New Drugs Online Report for the infliximab biosimilar, published by UK Medicines Information, included a quote from Celltrion, that: ‘the price of Remsima will be more than 30% cheaper than those of the original drugs’ in Europe. The National Health Service spent over GBP 120 million on Remicade in England in 2012, up 9.5% on the previous year.

Editor’s comment
For definitions of interchangeability and switching please see GaBI Online’s glossary of key terms [4].

Related Articles
Biosimilar trastuzumab approved in Korea

Celltrion applies for biosimilar infliximab approval in Japan

References
1.   GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 5]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
2.   Derbyshire M.  ECCO 2013 survey highlights lack of confidence in biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(3):154. doi:10.5639/gabij.2014.0303.034
3.   GaBI Online - Generics and Biosimilars Initiative. Celltrion files infliximab patent lawsuit in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 5]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-files-infliximab-patent-lawsuit-in-US
4.   GaBI Online - Generics and Biosimilars Initiative. Glossary of key terms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 5]. Available from: www.gabionline.net/Biosimilars/General/Glossary-of-key-terms

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