PURPOSE: This workshop will present an overview of the global access and adoption landscape for biosimilars, analyze barriers, and discuss solutions.

DESCRIPTION: Biosimilars hold the promise of reducing healthcare costs and improving patient access to life-saving biologics, alongside safety and efficacy similar to the originators. Challenges to realize this promise may however vary for different stakeholders and geographies.

While robust market competition has resulted in savings to healthcare systems across Europe, tremendous variation appears in biosimilar adoption across countries. Some markets in Europe have implemented policies that jeopardize long-term sustainability of biosimilars, while others have implemented multi-winner procurement approaches, considering factors such as manufacturer trust, quality, reliable supply, and services. Organized by the ISPOR Biosimilar Special Interest Group.

Prof. Simoens will discuss the current European landscape, including gaps and challenges e.g. choice of analytical approach, managed entry agreements, and valorization of value-added services; Dr. Vanderpuye-Orgle will discuss nuances in the approval process and payer expectations in the US that may contribute to sub-optimal adoption of biosimilars; Dr. Lockhart will discuss physician and patient perception and real-world usage of biosimilars. Studies show physicians are concerned about insufficient guidance on switching, evolving standards of care and patient-level outcomes. Similarly, patients worry about manufacturer quality, long-term safety and efficacy, and imperfect understanding of rapidly evolving concepts. Discussion will include current efforts to address gaps in real-world evidence to support physician and patient uptake; Dr. Courmier will present the manufacturer perspective and highlight some value-added attributes that may often be ignored in favor of deep discounts. Discussion will include a proposed value framework to assess biosimilars for overall societal benefit and not just the cheapest alternative to the originator.