Biosimilar Development & FDA Approval Pathways
KPIs to measure biosimilar market access performance and ROI in the US
KPIs to measure biosimilar market access performance and ROI in the US KPIs to Measure Biosimilar Market Access Performance and ROI in the US Context As the market for biosimilars expands in the United States, understanding and measuring their market access performance, pricing strategies, and return on investment (ROI) becomes crucial for regulatory affairs (RA) professionals. Biosimilars are biologic medical products highly similar to already licensed reference products and commonly used in various therapeutic areas. The regulatory framework governing biosimilars in the US is defined primarily by the Biologics Control Act (BCA), as amended by the Affordable Care Act (ACA),…