European commission gives final approval to generic infliximab copies
The European commission has given final marketing approval to the first generic versions of monoclonal antibody drug infliximab (Johnson & Johnson’s Remicade). UK firm Hospira’s Inflectra, and Remsima from Celltrion in South Korea can now both be launched in countries not covered by patents on Remicade.
The drugs are the most complex generic drugs yet to be approved in Europe, and are used to treat a variety of autoimmune diseases, including rheumatoid arthritis, Crohn’s disease and psoriasis.
The decision was widely expected after a European Medicines Agency committee recommended the drugs for approval in July of this year. Approval in the US is still hampered by the lack of decisive guidance on approval requirements for biosimilars from the Food and Drugs Administration.