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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.
Learning objectives:
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
reference product.
3. we address a few case studies.
Moderator:
- Mathew Cherian, Consultant - USA
Co - Moderator:
- Kaushik Desai, Advisor , Indian Pharma Machinery Manufacturers Association - India
Panellist:
- Alison Bascou, Senior Regulatory Affairs Manager, Becton- Dickinson - France