September 16,2013 | By Márcio Barra
Remsima (infliximab), a biosimilar of Remicade, was approved by EMA’s CHMP last June. Now, The European Comission has granted the final authorization for commercialization for what is the first biosimilar monoclonal antibody to be approved by the EC for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.
Remsima is from Hungarian company Egis pharmaceuticals and the Korean company, Celltrion Group, who both signed an agreement in 2010 for the distribution of 8 biosimilar products. Remsima is the first product to be launched. In this deal, Egis is to distribute biopharmaceutical products developed and manufactured by Celltrion.
Egis said in a statement that it would now launch Remsima in Central and Eastern European countries.
Remicade, the original product from Johnson & Johnson’s, is a monoclonal antibody that has been authorised in the European Union since 1999. Remicade generates $6 billion in annual sales, making it J&J’s biggest selling drug. Being a monoclonal antibody, this approval from the European Comission is remarkable as these are tremendously complex molecules. The molecule, Infliximab, is a monoclonal antibody that bings and blocks TNF-alpha, a pro-inflammatory factor released during autoimmune diseases.
The first biosimilar ever approved in Europe dates back to 2006, when Omnitrope (somatropin) was approved. Since then, a total of 12 biosimilar products were authorized. This decision is expected to set a precedent for future approvals of biosimilar antibodies, paving the way for a potentially profound shift in the biotech landscape – especially when twelve biological products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2020.