The New Era Of Biosimilar Development: Seizing The Opportunity Under EMA's Streamlined Guidelines

By Adam Tuszyner, Regulatory Compliance Specialist, Mabion S.A.

A major shift in the regulatory framework for biosimilars is underway, as the European Medicines Agency (EMA) has released a reflection paper signaling a move toward eliminating the costly and time-consuming Phase 3 efficacy studies. The U.S. Food and Drug Administration (FDA) appears to be moving in a similar direction, paving the way for a global transformation in how biosimilars are developed and approved.

By streamlining the approval pathway, development costs could be reduced by as much as 50%, dramatically lowering barriers to entry and creating new opportunities for small and medium-sized enterprises to compete in the European and U.S. markets. In this evolving environment, end-to-end contract development and manufacturing organizations (CDMOs) with extensive, multi-year expertise in biosimilar development — such as Mabion — are uniquely positioned to support companies in successfully navigating and capitalizing on this regulatory transition.

Now is the time for innovators and emerging players to seize this opportunity and engage with experienced partners to ensure long-term success in the biosimilar market.