EMA approves first biosimilars of a monoclonal antibody

June 28 2013 | By Márcio Barra

The European Medicines Agency’s Committee for Medicinal Products for Human Use(CHMP) has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars in Europe, Remsima and Inflectra, from Celltrion and Hospira.

Remsima and Inflectra are biosimilars of Remicade, Johnson & Johnson’s 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.

Both biosimilars contain the same active substance, infliximab, and both were recommended for the same indications as Remicade – rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.

Infliximab is a tumour necrosis factor (TNF) alpha inhibitor, a protein that promotes inflammatory responses, causing many autoimmune disorders.

This marks the first time that a biosimilar of a monoclonal antibody, a tremendously complex molecule, has been approved in the European Union.

The first biosimilar ever approved in Europe dates back to 2006, when Omnitrope (somatropin) was approved. Since then, a total of 12 biosimilar medicines were authorized. This decision will also set a precedent for future approvals of biosimilar antibodies, paving the way for a potentially profound shift in the biotech landscape. There were doubts regarding how were the European Authorities react to copies of a monoclonal antibody molecule and the data they would require to conduct the evaluation. For more details, follow this link for an excellent article over at Forbes.

“The price of Remsima will be more than 30 percent cheaper than those of the original drugs,” Kim Hyoung Ki, senior vice president and chief financial officer at Celltrion, told reporters in Seoul today, Bloomberg reported.





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