Pharmaceuticals

Regulatory Changes: Biosimilars

Friday, October 30, 2020

12:00 – 13:00 CET

Speaker(s)

Irena Milobratovic, MPharm, RAC

Senior Regulatory Affairs Manager
Arriello

Slides
Claudia Louati, MS

Policy Advisor
US Food and Drug Administration, Europe Office
Brussels , Belgium

Slides
Gabriela Marton

Quality and Regulatory Director
Arriello s.r.o

Slides

Chair(s)

Jennifer Neff, PhD

Director QM/RA & Medical Affairs
bess AG
Berlin, Germany

Description: In coming years, there is expected to be an avalanche of new biosimilars coming onto the market as the patents of innovator products expire. Therefore it is essential from our side to discuss biosimilars regulatory challenges and share current experience spreading awareness and knowledge about them among all stakeholders. This session wants to compare biosimilar and innovator medicinal product marketing authorization application requirements with focus on extrapolation of safety and efficacy clinical data and safety monitoring and to discuss different regulatory authorities approaches in biosimilarity recognition and share current experience in versatile cases. The knowledge earned can be practically used through biosimilars submission process and improve the communication with authorities.

Learning Objectives:

Define the difference between biosimilar and innovator medicinal product marketing authorization application
Describe the different approaches of regulatory agencies internationally in recognition of biosimilarity