European physicians across 12 countries now have access to a more cost-effective treatment for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other inflammatory conditions, with the approval of the first biosimilar monoclonal antibody for infliximab, CT-P13 (Remsima, Celltrion; Inflectra, Hospira), by the European Medicines Agency (EMA).
A number of targeted biological therapies that have changed the face of immune-mediated inflammatory diseases are reaching patent expiry. Several biosimilar drugs have been developed, the aim being to achieve similar efficacy at a lower cost. Only a few have been approved by the EMA, and just one has been approved by the US Food and Drug Administration.
Remsima has been launched in Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden, and the United Kingdom. Clinical trials of the drug have demonstrated it is comparable to the originator, Remicade (Janssen Biotech), in safety, efficacy, and quality. While biologics have positively changed the treatment of patients with many inflammatory conditions, their relatively high cost has placed a burden on healthcare budgets and therefore on patient access to treatment. The availability of biosimilars is expected to offer significant cost savings, especially in the long-term treatment of patients with chronic inflammatory diseases.
According to an online article in the European Medical Journal,1 biosimilars are projected to save the European healthcare system between €11.8 and €33.4 billion ($13.2 billion and $37.4 billion) by 2020. The biggest savings are predicted in France, Germany, and the United Kingdom. The use of biosimilar monoclonal antibodies such as Remsima is expected to generate the greatest savings, according to the article.
In a recent review article, the broader benefits and risks of Remsima were evaluated based on the drug’s clinical development data from the PLANETRA (Program evaluating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients) and PLANETAS (Programme evaLuating the Autoimmune disease iNvEstigational drug cT-p13 in AS patients) trials.
“While there is growing interest in biosimilars and their potential to reduce the cost of treatment for a number of debilitating diseases, clinicians and patients alike still have some questions,” wrote Henry Ireland, Drug Evaluations Commissioning Editor for Immunotherapy, “Using a detailed background on the clinical development of the first EMA-approved biosimilar monoclonal antibody, this article creates a useful framework for consideration of these new drug options.”
The review addressed questions on critical topics, including biosimilarity (how similar is “similar”?), extrapolation (can data from one indication permit use in another?), switchability (can patients be switched from the originator to the biosimilar easily?), and immunogenicity (are there differences?).
“Our review addressed these questions with respect to CT-P13. The drug is almost identical, and the EMA has accepted extrapolation for other conditions based on studies in rheumatoid arthritis and ankylosing spondylitis. The immunogenicity is considerable but the same as for infliximab. Finally, there are some encouraging data on switchability, but more real world data are needed,” said Jürgen Braun, MD, PhD, lead author.
- Webster Z. World’s first biosimilar monoclonal antibody launched in 12 European nations. European Medical Journal website. April 27, 2015. http://emjreviews.com/press/worlds-first-biosimilar-mono clonal-antibody-launched-in-12-european-nations/. Accessed April 29, 2015.
- Braun J, Kudrin A. Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases. Immunotherapy. 2015;7(2):73-87.