Biosimilar drugs step up complexity


The first ever generic monoclonal antibody therapies have been recommended for approval in Europe. The two biosimilar versions of infliximab (Johnson & Johnson’s Remicade) have passed assessment by the European Medicines Agency’s committee for medicinal products for human use, but will need to be fully approved by the European commission before they can be marketed.

Monoclonal antibodies are significantly larger and more complex than previously approved biosimilars, which include growth hormones and erythropoietin. Proving that they are functionally similar to the original drug is therefore complex. Both manufacturers, Celltrion and Hospira, had to complete human trials to prove that their generic infliximab products were as safe and effective as Remicade in treating autoimmune diseases.

Johnson & Johnson still has patent protection for Remicade in the majority of European countries. This means that the biosimilars, if finally approved, will either have to launch first in peripheral markets, or try to overturn the patent in court.


Related Content

Cast from the same mould?

31 May 2011 Premium contentFeature

news image

Development of generic biological drugs is gathering momentum. But as Rajendrani Mukhopadhyay finds out, the welcome they are...

US poised to approve its first ‘biosimilar’ drug

9 January 2015 Business

news image

FDA panel recommends Sandoz’s copy of Amgen’s Neupogen

Most Read

Refining Avogadro’s number on way to new kilo

21 July 2015 Research

news image

Most precise value yet reduces uncertainty down to 20 atoms in a billion

Weaving is believing

23 July 2015 The Crucible

news image

Philip Ball unpicks the history of science’s woollen wardrobe

Most Commented

Caramel colour in soft drinks linked to cancer

26 February 2015 News and Analysis

news image

Regulatory bodies and researchers sceptical of study on 4-MEI found in food colour

Weaving is believing

23 July 2015 The Crucible

news image

Philip Ball unpicks the history of science’s woollen wardrobe