EMA recommends approval of first two monoclonal antibody biosimilars
Remsima and Inflectra are recommended for authorisation in the same indications as Remicade, covering a range of autoimmune diseases
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission grants marketing authorisation approval for the first two monoclonal antibody biosimilars.
Remsima (manufactured by Celltrion) and Inflectra (from Hospira) both contain the active substance, infliximab. They have been shown to be similar to the biological medicine Remicade, a monoclonal antibody that has been authorised in the European Union since 1999, the EMA said.
Remsima and Inflectra are recommended for authorisation in the same indications as Remicade, covering a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.
Monoclonal antibodies are structurally complex substances that can locate and bind to specific molecules. In the case of infliximab this is to tumour necrosis factor (TNF) alpha, a protein promoting inflammatory response, which causes many of the clinical problems associated with autoimmune disorders. It is the first time that the biosimilar concept has been successfully applied to such a complex molecule, resulting in the recommended approval of a biosimilar version of infliximab.
A biological medicine can be authorised if it can be demonstrated that it is a close copy of a biological medicine already authorised for use in the EU
The EMA says a biological medicine can be authorised if it can be demonstrated that it is a close copy of a biological medicine that has already been authorised for use in the EU.
Since the approval of the first biosimilar medicine in Europe in 2006, the regulatory framework in place for the approval of biosimilars has produced a total of 12 authorised biosimilar medicines.
The framework consists of a number of overarching guidelines, which define and describe key concepts of biosimilar development programmes. These guidelines are complemented by product-specific guidelines, which give more detailed guidance to applicants in relation to the respective class of products.
The product-specific guideline for monoclonal antibodies has been in force since December 2012.
The CHMP opinions on Remsima and Inflectra will now be sent to the European Commission for a marketing-authorisation decision.
