Bioanalysis Zone

Ask the Experts – Biosimilars


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.



1What is required to gain approval for a biosimilar?

2Given the complexity and cost of development and manufacturing, are biosimilars more affordable therapeutic options?

3How can you demonstrate biosimilarity, what are some of the techniques used?

4Do you follow a one assay approach or two assay approach for your PK bioanalytical assays? What are the pros and cons?

5Do you follow a one assay approach or two assay approach for your ADA bioanalytical assays? What are the pros and cons?

6Do you follow a one assay approach or two assay approach for your neutralizing antibody assays? What are the pros and cons?

7What do you consider to be the main bioanalytical challenges for biosimilar drug development?

8What are the challenges for demonstrating that immunogenicity risks for the biosimilar are less or equivalent to the innovator material?

9What have been the most exciting advances in developing biosimilars?

10With the gain in popularity for biosimilars how can the field be regulated and standardized?

11What are the different challenges that you have experienced with different regulatory regions? Are the challenges consistent across the regulatory authorities?

12How do you see the field evolving over the next 5-10 years? What are the main obstacles to be overcome?


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