February 25, 2015 | By Márcio Barra
Celltrion´s biosimilar of the biologic Remicade (infliximab), will be launched in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden under the brand name Inflectra by Hospira, and in Germany, Italy, Britain, the Netherlands, Belgium and Luxembourg under the brand name Remsima by privately-held Indian drug company Mundipharma.
Remicade Biosimilars have been available in certain smaller markets in Europe, such as Norway, for several months, but this is the first time a biosimilar of a monoclonal antibody, which are molecules with considerable complexity, will be launched into major markets. The price discount is estimated to be around 20-30 percent cheaper than the original drug, as stated by Paul Greenland, head of biologics at Hospira.
Biosimilars serve a similar purpose as generic drugs, but with some key differences and more stringent requirements, owing to the differences in replicating large molecules compared to smaller molecules. Seeing as biologic drugs are produced from living organisms, the production processes are quite sensitive to changes in the manufacturing processes, and thus is it very hard to create an exact replica of the original molecule. Biosimilars must be shown in clinical trials to be close enough to the original molecule to provide the same therapeutic effect.
Hospira was acquired by Pfizer earlier this month in a $17 billion deal , with the potential to establish a strong presence in the biosimilar market being one of the key drivers behind the decision.
Inflectra, or Remsima, was approved by EMA’s CHMP in June 2013. Final authorization from the European Comission for commercialization arrived in September 2013. The drug was 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.
Remicade, which is jointly owned by Merck and Johnson & Johnson of the US, 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 binds 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.