Chapter 6 - Regulatory Standards for the Approval of Biosimilar Products: A Global Review

Abstract

A biosimilar is a copy of a biological molecule that claims to be similar to an innovative biological protein therapeutic product (reference product) that is already approved and marketed. The approaching expiry of patents on various innovative biological products, combined with the enactment of legislation for the approval of biosimilar products in major regions, has led to a substantial increase in the pharmaceutical industry’s interest in developing biosimilar products. Over the past few years, the approval standards and policy issues surrounding the approval of biosimilar products have been key topics of discussion for interested stakeholders such as the healthcare community, patient advocacy groups, the pharmaceutical industry and regulatory authorities. The European Union (EU) has served as the leader in establishing a dedicated regulatory pathway for the approval of biosimilars. Subsequent to the EU, other regions around the world, including Australia, Canada, Japan, and recently, the United States, have developed legislation and regulatory guidance for biosimilar products. While many of these regional guidance documents have similar scientific principles, differences in certain topics and standards exist across the regions. As the global market for biosimilars continues to develop, the regulatory authorities will receive more applications for biosimilar products. Today, regulators are grappling with the challenges of developing biosimilar products, and as technology advances and more complex biosimilar products are being developed, new issues will arise that need to be addressed within the regulatory environment. Biosimilars will continue to play a critical role in healthcare systems around the world, and all stakeholders, including the regulatory authorities and the pharmaceutical industry, should collaborate to address the challenges and develop appropriate, science-based standards to ensure patient access to high-quality biosimilar products.