On 28 July 2013, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced the approval of the first two monoclonal antibody biosimilars [1]. The biosimilars in question, Celltrion’s Remsima and Hospira’s Inflectra, have been shown to be similar to Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

The two biosimilars have been approved for the same indications as Remicade, i.e. covering a range of autoimmune diseases, such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. However, the issue that gastroenterologists have is that the approval of the biosimilars is based on clinical trials in ankylosing spondylitis and rheumatoid arthritis patients and not in inflammatory bowel disease (IBD). The approval for use in IBD, including Crohn’s disease and ulcerative colitis, has been based on extrapolation of data.

The Sociedad Española de Patología Digestiva (Spanish Society of Gastroenterology) and Sociedad Española de Farmacología (Spanish Society of Pharmacology) have issued a joint position statement stating that the task force ‘considers that results obtained from studies in rheumatoid arthritis should not be extrapolated to IBD since the biological variability of these complex structures will not ensure a lack of noticeable changes in efficacy and safety’ [2]. 

The task force adds that ‘as with originals, in order to obtain a given indication a biosimilar should be tested in a clinical trial specifically designed to that end’. However, this is not the view of EMA, which has stated that ‘if clinical similarity can be shown in a key indication, extrapolation of efficacy and safety data to other indication(s) of the reference product may be possible’ under certain conditions [3].

Despite EMA’s stance on biosimilars this position has also been expressed by different societies in Europe and around the world, including the European Cancer Organisation, the Mexican College of Rheumatology and the American College of Rheumatology [4-6].

Conflict of Interest
The authors signing the Spanish position statement [2] do so on behalf of Sociedad Española de Patología Digestiva (SEPD) and Sociedad Española de Farmacología (SEF). Neither of these scientific societies nor any of their working group members are in whatever manner linked or affiliated with any companies developing biosimilars.

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EC approves first monoclonal antibody biosimilar

References

1.  GaBI Online - Generics and Biosimilars Initiative. EMA approves first monoclonal antibody biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 25]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-first-monoclonal-antibody-biosimilars

2.  Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, Hinojosa J, Tejerina T. Joint position statement by Spanish Society of Gastroenterology and Spanish Society of Pharmacology on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig. 2013;105(1):37-43.

3.  GaBI Online - Generics and Biosimilars Initiative. Efficacy, extrapolation and interchangeability of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 25]. Available from: www.gabionline.net/Biosimilars/Research/Efficacy-extrapolation-and-interchangeability-of-biosimilars

4.  Danese S, Gomollon F; Governing Board and Operational Board of ECCO. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013;7(7):586-9.

5.  Espinosa Morales R, Díaz Borjón A, Barile Fabris LA, et al. Biosimilar drugs in Mexico: position of the Mexican College of Rheumatology, 2012. Reumatol Clin. 2013;9(2):113-6.

6.  American College of Rheumatology. Position statement on Biosimilars [cited 2013 Oct 25]. Available from: www.rheumatology.org/Practice/Clinical/Position/Position_Statements/

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