Trials of biosimilar monoclonal antibody prove biosimilarity

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Trials of biosimilar monoclonal antibody prove biosimilarity

Biosimilares/Novedades | Posted 22/06/2012 0 Post your comment

South Korean biotechnology company Celltrion presented the PLANET clinical studies results of phase I and phase III trials for its first monoclonal antibody biosimilar (CT-P13) of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab) at the Annual Congress of the European League Against Rheumatism (EULAR) held in Berlin, Germany, on 6–9 June 2012. The results demonstrated the biosimilarity of CT-P13 to the reference drug, supporting the company’s intention to launch the biosimilar monoclonal antibody globally.

Remicade (infliximab) is a chimeric monoclonal antibody approved by EMA in 1999 for the treatment of ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, psoriatic arthritis, and rheumatoid arthritis.

The phase I trial compared the pharmacokinetic profile of CT-P13 with that of infliximab, as well as evaluating the efficacy and overall safety of both treatments in 250 patients with ankylosing spondylitis. The phase III trial on the other hand compared the clinical efficacy and overall safety of CT-P13 with those of infliximab in 606 patients with active rheumatoid arthritis.

Equivalence in pharmacokinetics between the biosimilar and the reference product was demonstrated during the phase I trial. Equivalence in safety and efficacy was demonstrated during both the phase I and phase III clinical studies.

Celltrion’s biosimilar plans
Celltrion, as a contract manufacturing organisation, has an agreement with US-based generics major Hospira to develop and market eight biosimilars, including infliximab [1].

Celltrion applied for Korean Food and Drug Administration approval in February 2012 [2] and is preparing to launch CT-P13 in approximately 100 countries including the EU and other developed markets. Product registration approvals are anticipated in around 40 countries by the end of 2012.

The company has at least six other biosimilars in various stages of development, covering indications such as breast cancer, Hodgkin’s lymphoma, colorectal cancer, colon cancer and respiratory syncytial virus, and is committed to becoming one of the world’s leading companies in biosimilars.

The series of two articles that follows presents in more detail the results from the phase I and phase III trials.

Phase I trial of biosimilar infliximab proves biosimilarity

References

1. GaBI Online - Generics and Biosimilars Initiative. South Korea to emerge as global leader in biosimilar R & D [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 22]. Available from: www.gabionline.net/Biosimilars/News/South-Korea-to-emerge-as-global-leader-in-biosimilar-R-D

2. GaBI Online - Generics and Biosimilars Initiative. Successful completion of biosimilar infliximab programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 22]. Available from: www.gabionline.net/Biosimilars/News/Successful-completion-of-biosimilar-infliximab-programme

Source: Celltrion, EULAR