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Regulatory considerations when choosing device components in biosimilar development
he choice of delivery device or container closure system versus the Reference Listed Drug is a key consideration when developing a biosimilar. Can a biosimilar be developed using a different container closure system than the reference Listed Drug and if yes, how different can this container
closure system be? If the reference is in a vial or a prefilled syringe, can the biosimilar be in an autoinjector? What are additional requirements that need to be considered in order to be able to claim interchangeability.
1. we focus on requirements applicable to biosimilars when targeting the US or the EU markets.
2. we discuss acceptable differences in device-component between a biosimilar and the
3. we address a few case studies.
- Mathew Cherian, Consultant - USA
Co - Moderator:
- Kaushik Desai, Advisor , Indian Pharma Machinery Manufacturers Association - India
- Alison Bascou, Senior Regulatory Affairs Manager, Becton- Dickinson - France