Follow-On Biologics Poised to Expand Global Health Care Access and Lower Costs

Follow-on biologics, including biosimilars, biobetters, and bioparallels, hold significant promise for creating a more equitable and accessible global health care landscape by driving down costs and enabling budget-neutral expansion of treatment options, according to Ivo Abraham, PhD, director, center for health outcomes and pharmacoeconomic research at The University of Arizona Cancer Center.

Abraham delivered a keynote session at the 2025 Festival of Biologics USA, held from April 23-24 in San Diego, California, about biosimilars promoting value, access, and equity.1 He introduced the concept of biobetters, defining them as novel molecules designed to improve the properties of existing ones. Additionally, bioparallels are novel follow-on biologics that do not reference another biologic and compete on price through a different regulatory route in the US.

“Whether it's a biosimilar, biobetter, or bioparallel, this yields cost efficiencies. Importantly, this enables budget-neutral expanded access,” Abraham stated.

Follow-on biologics also improve patient equity and expand access on a global scale, in addition to lowering treatment costs, yielding cost-efficiencies, and enabling budget-neutral expanded access. The advancement of follow-on biologics can be demonstrated with comparative values, such as budget impact and affordability analysis, as well as shadow modeling of value approaches. Demonstrating the comparative values of follow-on biologics through cost-effectiveness studies and alternative metrics like quality-adjusted life years remains significant.

Building evidence based on real-world clinical practice patterns and outcomes can also help advance the use of follow-on biologics. Abraham emphasized the importance of due diligence, clinical review, and validation methods. He suggested modeling risk and risk exposure to anticipate, manage, and mitigate risk. This can be done by modeling the risk of interchangeability with the reference product, the risk with consequences of administration failure, price evolution and erosion, along with supply chain disturbances.

“The modeling of interchangeability can be modeled statistically, and those results will most likely be much more informative, much more robust than having a switching trial with a few 100 patients, especially in terms of safety data,” Abraham stated.

Exclusivity contracts and private labeling impact provider adoption, and clinical guidelines influence treatment decisions. Supply chain disturbances, like natural disasters and import/export constraints, were identified as potential risks that alternative production and distribution strategies could mitigate.

Potential remains in bringing follow-on biologics as biological therapies to lower- and middle-income countries, emphasizing the need for realistic and collaborative approaches. Price adjustments can help make follow-on biologics more accessible in global markets, and public-private sector collaboration holds potential.

“This is where international organizations, international foundations, may come in and be helpful. We need to facilitate public-private sector collaboration, design innovative and sustainable pricing and financing models, and enable provider innovation awareness and trust campaigns,” Abraham concluded.

Reference

Abraham I. Biosimilars: promoting value, access, and equity. Presented at: Festival of Biologics USA; April 23-24, 2025; San Diego, CA.