Biosimilars are biological medicines that are highly similar in structure, biological activity, safety, and effectiveness to an already approved originator biological medicine (“reference medicine”). Globally, they play an important role in expanding patient access to treatment and are subject to specific regulatory frameworks in the European Union and United States. As scientific knowledge advances and more experience with biosimilar products is gained, these regulatory frameworks are evolving to support more efficient biosimilar development.
Join ASPHALION expert Jon Gibblin for a practical webinar where he will provide a clear, practical overview of the current regulatory landscape for biosimilars.
In this webinar we discuss and answer the following questions:
- What is a biosimilar, and how is it different to a generic medicine?
- What are the regulatory and scientific principles used to demonstrate biosimilarity?
- How does the approach to the regulation of biosimilars differ in the European Union and the United States, and is regulatory alignment increasing?
- What are the most recent developments in global biosimilars regulation?
- What are the future perspectives for biosimilars development?
Register here for the webinar: https://bit.ly/4zetQER
If you have any questions, please contact us at [email protected]
