The First Biosimilar Antibody Therapeutic is Approved by the EMA

bioprod no background guest blog

This week’s BioProduction blog post is by Professor Roy Jefferis, Division of Immunity and Infection, University of Birmingham, UK

“The EMA has approved the biosimilar Remsima for all indications for which the innovator product Remicade (Infliximab) is approved. Approval by the EMA is seen as a landmark event as I understand some biosimilar programmes have been progressed slowly, partly due to uncertainty and/or lack of confidence in regulatory approval pathways. Importantly, approval for Remsima demonstrates that the EMA has confidence in its ability to evaluate the comparability of biosimilar antibody products. The successful development and approval of Remsima, following EMA guidelines, may act as an incentive for the biosimilar “industry” and establishment of definitive FDA guidelines.

The EMA website announcement includes the following statement:

“Remsima is a biological medicinal product similar to the reference product Remicade (infliximab) authorised in the European Union since 13 August 1999. Studies have shown Remsima to have a comparable quality, safety and efficacy profile to Remicade (infliximab). A pharmacovigilance plan for Remsima will be implemented as part of the marketing authorisation.”

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002576/smops/Positive/human_smop_000532.jsp&mid=WC0b01ac058001d127

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

To find out more about Roy’s presentation at BioProduction this year, please visit our website

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