In this ‘Ask the Experts’ feature we will be discussing the use of biosimilars with a number of leading experts across the field. The series will explore the role of biosimilars, address the benefits and challenges of creating them and how they have gained momentum within the pharmaceutical industry. Biosimilars are subsequent versions of an innovator product and have gained popularity over the last 30 years. They possess biologically similar properties to regulatory approved biologics, however, because of the complexity of structure and manufacturing are not identical to the reference product.
Regulatory approval of biosimilars requires developers to meet high quality, safety and efficacy but how is this regulated and standardized internationally? Regulatory standards exist but there are no clear bioanalytical guidelines for working with biosimilars, what are the appropriate bioanalytical tests and analytical technologies used to demonstrate similarity? With more biologics losing patent protection in the next few years – what does this mean for the future of biosimilars? To address these questions and more, key figures from pharma, CROs, biotech and academia share with us their experiences and thoughts on biosimilars, giving our members a 360° opinion piece.
A series of questions and responses collected from the various experts involved will be published in instalments below – so keep checking for updates.