The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorizations for the first two monoclonal antibody biosimilars.
Remsima (Celltrion Healthcare Hungary Kft) and Inflectra (Hospira UK Limited) both contain the same known active substance, infliximab, which has been authorized in the European Union since 1999 as Remicade. In the application dossiers, Remsima and Inflectra have been shown to be similar to Remicade and are recommended for authorization 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, the committee reports.
Infliximab is a monoclonal antibody that locates and binds to tumor necrosis factor (TNF) alpha, a protein promoting inflammatory response, which causes many of the clinical problems associated with autoimmune disorders. This decision 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.
According to EMA, the biosimilar concept foresees that a biological medicine can be authorized if it can be demonstrated that it is a close copy of a biological medicine that has already been authorized for use in the European Union. 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 authorized biosimilar medicines. The framework consists of a number of overarching guidelines that define and describe key concepts of biosimilar development programs. Product-specific guidelines 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. As for all biosimilars, the emphasis in the development program is on demonstrating comparability to the reference medicine. An applicant has to submit studies to the Agency that show that the medicine is a biosimilar of the reference medicine, i.e. that it does not have any meaningful differences from the reference medicine in terms of its quality, safety and efficacy.
Applicants are also required to implement a risk-management plan to confirm the long-term efficacy and safety of a biosimilar, including the detection of any unexpected rare adverse effects when the medicine is used in clinical practice.
The CHMP opinions on Remsima and Inflectra will be sent to the European Commission for adoption of a marketing-authorization decision.