Individual FIP Digital Events

FIP offers a number of individual digital events on various topic within pharmacy practice, science and education.

Regulatory considerations when choosing device components in biosimilar development

20 July 2021

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

Regulatory considerations when choosing device components in biosimilar development

20 July 2021

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

Regulatory considerations when choosing device components in biosimilar development

20 July 2021

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