In recent years, exciting advancements in biosimilars assay technology have led to a deeper comprehension of structural activity relationships. This means that the analytical methods now offer the highest degree of assurance when it comes to Biosimilarity. However, the requirements for comparative efficacy trials have mostly remained the same, especially for complex proteins such as monoclonal antibodies.
We must consider the challenges and limitations of comparative efficacy trials:
Faced with mounting challenges, regulatory authorities are beginning to re-evaluate the existing criteria for comparative efficacy studies. This hot topic took centre stage at a workshop held by the US Food and Drug Administration (FDA) and the International Pharmaceutical Regulators Program (IPRP) Biosimilars Working Group (BWG) in September 2023. A diverse group of speakers from regulatory bodies and industry giants, such as the UK MHRA, WHO, EMA, Health Canada, Japanese PMDA, Korean MFDS, and US FDA, contributed their valuable insights.
The following are the insights from different regulatory bodies:
With all these developments, regulatory authorities are progressing toward more streamlined and quality-based biosimilar approval processes that emphasise product quality.
For more information on the guidelines, please click here World Health Organization Guidelines on Evaluation of Biosimilars
For more information on our Regulatory Consulting and Compliance Services please click here https://www.spgl.eu/services/regulatory-consulting-compliance
To view the FDA workshop details please click here. FDA Increasing Efficiency Biosimilar Development Programs Re evaluating