Following its first peer-reviewed scientific paper on biosimilar medicines development: the Path Towards Tailored Clinical Biosimilar Development (BioDrugs), the International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, today released a new policy paper: “Developing a Regulatory Framework Supporting Biosimilar Competition: The Opportunity for Tailored Clinical Biosimilar Development.”
Introduction
Biologic medicines are complex medicines developed in living cells that offer treatment options for patients suffering from many serious conditions, such as cancer, diabetes and rheumatoid arthritis. Biosimilar medicines are versions of biologic medicines that have no meaningful differences in safety or efficacy/effectiveness and enable competition following resolution of market exclusivity periods. They have vast potential to improve the cost-effectiveness of biologic therapies and provide broader access to medicines for patients.
Health inequities remain significant in communities around the world, across the range of health care services and products, and this is particularly true for biologic therapies. Biologics have revolutionized the treatment landscape for many diseases, but at a significant financial cost to health systems and patients. Despite the advent of biosimilar competitors, equity in access to biologic therapies remains a challenge, in large part due to systemic hurdles preventing optimal use of biosimilar medicines.
Policy-makers at all levels can play a role in fostering an environment conducive to maximizing the potential of biosimilar medicines to reduce inequities in healthcare. Biosimilar medicines not only expand access to current treatments previously out of reach for some patients, they also allow health systems to provide increased access to innovative treatments, diagnostics and cures through more efficient use of available funds. The global community has committed to achieving Sustainable Development Goal 3: Ensuring healthy lives and promoting well-being for all at all ages, including reducing by one-third premature mortality from non-communicable diseases by 2030.
Equitable access to safe, effective, quality and affordable medicines is a critical component of achieving this collective goal. Ensuring that patients get the medicines they need, today and in the future, requires collaboration between all affected stakeholders, including regulatory authorities, pricing and reimbursement agencies, payors, medical societies, healthcare providers and patients.
Regulatory authorities play a central role in creating a sustainable environment for biosimilar medicine development, approval and patient access. Building on their considerable scientific knowledge and cumulative experience with biologic medicines, regulators can expand access to biologic medicines by expediting biosimilar approval and ensuring accurate healthcare stakeholder understanding of biosimilarity to translate approval to appropriate utilization. This can be achieved by coupling tailored clinical development with advanced comparative analytics and educating stakeholders on the quality, safety and efficacy of biosimilar medicines and the comparative utility of analytical and clinical data to support biosimilarity.
Adapting the biosimilar development paradigm to encourage tailored clinical development programs will facilitate development of these products by ensuring that the studies are designed to quickly and precisely provide the relevant and definitive data to establish that a biosimilar will have no clinically meaningful difference to the biologic that it is designed to match. This in turn will have a direct impact on the sustainability of biosimilar competition and contribute to increased patient access.
