There are currently no biosimilar monoclonal antibodies (mAbs) or soluble receptor constructs (cepts—large, intricate proteins with unique tertiary and quaternary structures that are inherently difficult to replicate) approved by EMA or FDA for treatment of rheumatic diseases, although randomized controlled trials are complete or ongoing, see Table 1 [1]. EMA is, however, reviewing two applications for marketing authorization of infliximab biosimilars, one of which is thought to come from South Korean biotechnology company Celltrion, which has already received approval for its product for rheumatoid arthritis and autoimmune diseases from the regulatory authorities in Korea [2].

Table 1: Biosimilars under development for treatment of rheumatic diseases

Legislation that regulates the manufacture, registration and approval of biosimilars varies considerably between different countries, and ‘copy biologicals’ approved in less highly regulated markets may not follow the same strict requirements as is required in Europe by EMA.

Biosimilars, as with all biologicals, are complex molecules to produce, and uncertainties surrounding the exact regulatory requirements have led some companies to suspend their development. This, however, has not put off others and, with patent expiries looming, rheumatologists should expect biosimilars to be with them very soon.

Conflict of interest
Most of the authors of the research article had received study support and/or consultancy fees from both generics and originator drug manufacturers. The research article was a result of the roundtable on ‘Biosimilars for the treatment of rheumatic diseases’, Berlin, Germany, 25 April 2012, which was made possible by an unrestricted educational grant from F. Hoffmann-La Roche. The sponsor had no involvement in the roundtable agenda or development of the manuscript.

Related articles

Biosimilars in rheumatology

EU guidelines for biosimilars

Challenges in the development of biosimilars mAbs

References

1.  Dörner T, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis. 2013;72(3):322-8.

2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 May 3]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.