WHO International Standards for Bevacizumab and Trastuzumab now available
The National Institute for Biological Standards and Control (NIBSC) has expanded its range of monoclonal antibody standards. The 1st International Standards for Bevacizumab (NIBSC code: 18/210) and Trastuzumab (NIBSC code: 19/108) have now been added to our product catalogue, following their establishment by the World Health Organization Expert Committee on Biological Standardisation (WHO ECBS) last year. The use of these standards will help to ensure the safety, quality and efficacy of monoclonal antibody therapies being increasingly used and developed worldwide.
Meeting a global need for standardisation
Monoclonal antibodies have revolutionised the treatment of a variety of diseases including cancer, inflammation, autoimmune conditions and infectious diseases. In recent years, the global market has expanded as patents for early ‘blockbuster’ monoclonal antibodies expire, paving the way for the development of more cost-effective biosimilar drugs.
As they are large and highly complex molecules made in living cells, monoclonal antibodies are very sensitive to differences in manufacturing processes. Therefore, to gain regulatory approval, biosimilars are subjected to a rigorous comparability exercise, involving measurements of bioactivity, in order to demonstrate similarity to a licensed originator product.