EGA welcomes first biosimilar MAb approvals in Europe

Following the European Medicines Agency’s CHMP recommendation, the European Commission (EC) has just approved the first two infliximab biosimilar products, Inflectra (from Hospira) and Remsima (from Celltrion), both referenced to Remicade (The Pharma Letter September 11).

The European Generic medicines Association (EGA) welcomes these approvals which reinforce Europe’s leading role in biosimilar medicines. Most importantly, this move creates the conditions for member states to increase access to treatment for patients with auto-immune illnesses such as rheumatoid arthritis and inflammatory bowel disease.

With quality, safety and efficacy thoroughly assessed by the European Medicines Agency’s scientific regulatory body, member states' price and reimbursement authorities will now look to establish the appropriate conditions for the fast market entry of these medicines.