Regulatory Approval Process of Biosimilars

Biosimilars are biological medicinal products that are highly similar structurally to a well-established licensed Reference (Comparator) product and there are no clinically meaningful differences between them. However, the regulatory framework which ensures their safety and efficacy is continually evolving in the light of technological advances as well as experience in the licensing and use of biosimilars. The goal of this educational session is to discuss an overview of the regulatory approval... Read more