Introduction

After consultation with industry, the FDA published draft biosimilars guidelines in February 2012. Although details are lacking in a number of areas such as interchangeability, the guidance sets out the agency’s broad views and gives developers greater certainty for the initiation of development programs.

Features and benefits

• Insight into the key biosimilar regulatory developments globally
• Assessment of the key strategies incorporated by players as a response to these changes in biosimilar regulation

Highlights

The FDA published draft biosimilars guidelines in February 2012.

In the EU, the EMA has published guidance for the development of interferon beta biosimilars.

In order to meet physician and patient demands for more complex drugs and reduce the financial burden on payers, the Iranian government is keen to promote the Iranian biosimilars industry.

Your key questions answered

• Evaluate the evolving regulatory environment around the world and how this impacts biosimilar market access and uptake.
• Gain insight into the strategies employed by payers and pharmaceutical companies as a response to these changes in the regulatory environment.