been applied to support the development of other complex protein products derived from DNA recombinant technologies, for example with the establishment of the WHO International Standards for pegfilgrastim and etanercept.

Responding to a growing market

Monoclonal antibodies have revolutionised the treatment of many important diseases in oncology and inflammation and in 2016, made up over 5 of the top best-selling drugs that year. As patents for the original products expire, manufacturers can now develop new biosimilar medicines for popular therapeutic mAbs.

Dr Meenu Wadhwa, Section Leader in the Division of Biotherapeutics at NIBSC comments:

“The expiry of patents is leading to the rapid growth of mAb biosimilars for a range of indications including autoimmune diseases and oncology, which helps to improve affordability and access to these essential medicines. With support from WHO, we’re continuing to develop our range of standards to other mAb products such as adalimumab, trastuzumab, cetuximab and bevacizumab to ensure the provision of safe and effective medicines globally”.

"Therapeutic drug monitoring (TDM) assays are currently gaining momentum as a tool for patient management, helping to identify patients eligible for dose reduction or increase, treatment termination or switching within, or out-of-class. Extending the use of the infliximab standard for the standardisation of TDM assays will support clinical decision-making where possible and facilitate the efficacy and cost-effectiveness of therapeutic biological medicines.”

To find out more about upcoming mAb standards projects or to donate candidate material or participate in an upcoming collaborative study contact