Biosimilars can be considered as some of the best-selling biopharmaceuticals. Biosimilar development for major markets such as US/EU as well as other regions of the world is still increasing. Analysis shows that developers who prepare global upfront strategies benefit from efficiency and save resources leading to faster market entry. This webinar offers a detailed approach for development of a global biosimilar strategy, outline the regulations, some key US/EU differences and summarizes common pitfalls and how to avoid them.
About the Speaker: Ms. Zeb Younes
Associate Director, Regulatory Affairs at PharmaLex UK
Zeb Younes has a wealth of experience in biopharmaceutical and biosimilar development lifecycle from proof of concept through to, and beyond commercialization with both laboratory and desk based experience. She has worked with RMAT/ATMPs, vaccines, recombinant proteins including monoclonal antibodies and derivatives and over 10 different biosimilar products. She developed and implemented lean systems to increase operational efficiency and has participated and led MHRA/FDA and corporate audits.