The need for affordable health care, especially for an aging population, and the growing number of patent expiries for biological medicinal products offer opportunities for biosimilars. However, scientific and regulatory challenges may have an impact on patients and health care professionals as well as pricing and reimbursement authorities. Since the introduction of the biosimilar pathway in 2005, numerous biosimilars have gained marketing authorizations from the European Commission. The European Medicines Agency (EMA) is currently updating its overarching biosimilar guidelines and the European Commission is working to ensure adequate access to and uptake of biosimilar products. In this session, the EMA will give an update on the current status of EU biosimilar guidelines and discuss with biopharmaceutical producers how to make the pharmaceutical environment conducive to the uptake of biosimilars.

Learning Objectives:

• Evaluate recent changes in the guidelines for biosimilars in the EU
• Analyze the rationale for and impact of recent changes in the EU guidelines for biosimilars
• Discuss the challenges for biosimilars from industry point of view

Ability Level: All

Session ID: 1978