Biosimilars and Future Biotherapeutics

Global Trends and Challenges in Biosimilar Adoption

The global adoption of biosimilars has accelerated over the past decade, offering promising solutions to reduce healthcare costs and expand access to life-saving biologic therapies. However, the pace and extent of biosimilar uptake vary widely across regions due to differences in regulatory frameworks, healthcare infrastructure, market dynamics, and stakeholder perceptions. In Europe, biosimilars have seen the most successful integration, thanks to the early establishment of clear regulatory pathways by the European Medicines Agency (EMA), supportive health policies, and well-structured procurement systems. Countries such as Germany, the Netherlands, and Norway have implemented effective tendering processes, physician incentives, and education programs, leading to rapid market penetration and significant cost savings. European case studies demonstrate that policy-driven strategies, coupled with real-world evidence and physician engagement, can overcome initial skepticism and encourage biosimilar utilization in complex disease areas such as oncology and rheumatology.In the United States, biosimilar adoption has been slower but is steadily progressing. The regulatory pathway, established through the Biologics Price Competition and Innovation Act (BPCIA), provides a framework for biosimilar approval, including the possibility of obtaining an “interchangeable” designation. However, market access has been hindered by patent litigation, rebate traps, and payer dynamics that favor originator biologics due to pre-existing contracts and financial incentives.