EMA reviews its first biosimilar monoclonal antibody

Published: 2012-06-13

EMA reviews its first biosimilar monoclonal antibody

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in April 2012 the agency will be reviewing a new drug application for a biosimilar version of infliximab.

Infliximab is a monoclonal antibody, which works by binding to tumour necrosis factor-alpha (TNF-α). TNF-α is a chemical messenger (cytokine) and a key part of the autoimmune reaction. Infliximab therefore acts as an anti-inflammatory drug and is used to treat ankylosing spondylitis, Crohn’s disease, psoriatic arthritis and psoriasis, rheumatoid arthritis, ulcerative colitis.

The drug is a biosimilar of Johnson & Johnson’s blockbuster Remicade, which had sales of US$8 billion in 2010.

Although EMA has not identified the company behind the application, a likely candidate is South Korean biotechnology company Celltrion, which announced in February 2012 the successful completion of its clinical programme for its infliximab biosimilar.

Celltrion has a partnership with US-based generics major Hospira to develop and market eight biosimilars, including infliximab and cancer drug trastuzumab.

Biosimilars for epoetins, filgrastim and somatropin have already been approved by EMA; however, this is the first application for a biosimilar of a monoclonal antibody to be submitted to EMA.

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Source: www.gabionline.net

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