Key Aspects of Biosimilar Development

⦁ Regulatory Compliance:

In vitro studies are essential for meeting regulatory requirements set by bodies like the FDA, EMA, and other international regulatory agencies. They provide the scientific evidence needed to demonstrate that the biosimilar is highly similar to the reference product.

⦁ Cost and Time Efficiency:

In vitro methods are generally faster and more cost-effective than in vivo studies (studies in living organisms), allowing for quicker development and assessment of biosimilars.

⦁ Risk Mitigation:

Early identification of potential issues with the biosimilar, such as differences in potency or stability, can be addressed before proceeding to more expensive and time-consuming clinical trials.