Coordinated procurement and biosimilar adoption increased the number of patients treated across 5 major therapies in the Netherlands by up to 86% while reducing costs, one of several examples panelists cited to show how biosimilar medicines are expanding access to care worldwide during a webinar held for Global Biosimilars Week 2026.
The International Generic and Biosimilar Medicines Association (IGBA) hosted the webinar, "Value of Global Access: The Benefits of Prioritizing Biosimilars," on October 21, 2026, as part of its annual Global Biosimilars Week. Giuseppe Randazzo, senior vice president of sciences and regulatory affairs for the Association for Accessible Medicines (AAM) and the Biosimilars Council, moderated a discussion among panelists representing industry, regulators, payers, and global health organizations. Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, joined the panel in place of Matt Erick, the company's chief medical officer, who was unable to attend.
Who Spoke
- Giuseppe Randazzo, MS, senior vice president of sciences and regulatory affairs, Association for Accessible Medicines and the Biosimilars Council (moderator)
- Elena Wolff-Holz, MD, global head of clinical development, Biocon Biologics
- João Tavares Neto, senior regulatory reviewer, Office for Biological Products Evaluation, Brazil's Health Regulatory Agency (Anvisa)
- Jody Cox, vice president, Biosimilars Canada
- Santiago Millan, technical lead, Global Platform for Access to Childhood Cancer Medicines, World Health Organization
- Chetali Rao, senior researcher and legal advisor, Third World Network
- Robert Russell-Pavier, director for policy and economics, Medicines UK
Biosimilars Deliver Measurable Value Worldwide
Randazzo, who opened the panel, said biosimilar competition builds health system resilience as well as generates savings. In the US, a report released by AAM and the Biosimilars Council in September 2025 found that biosimilar competition had enabled 460 million incremental days of patient therapy since 2015 that would not otherwise have occurred, alongside $56.2 billion in cumulative savings over the same period.1 He also cited biosimilar manufacturing's contribution to the European economy, estimating that it adds about €25.6 billion annually to gross domestic product and supports more than 81,000 jobs, with roughly 1000 biosimilar development programs active globally.
“When a biologic has no biosimilar in development, patients, health systems, and societies miss out on an opportunity to infuse value into their community beyond the drug itself,” Randazzo said.
Country Experiences Show Biosimilar Transition Gains
Cox described how Canada's public drug plans overcame early uptake challenges by adopting biosimilar transition policies, beginning when British Columbia introduced the country's first such policy in 2019. Every public drug plan in Canada has since adopted a similar approach, under which patients are given a defined period to switch from an originator biologic to a biosimilar under their clinician's guidance. A 5-year report on British Columbia's program found that more than 40,000 patients transitioned to biosimilars with no detrimental impact on hospital utilization, physician visits, or other patient outcomes, while the province saved approximately $732 million.2 “That savings was reinvested into coverage of a long list of drugs, medical devices, and tests that patients need, including inhalers for chronic obstructive pulmonary disease, cystic fibrosis treatments, and adult ADHD medications,” Cox said.
Tavares Neto described how biosimilars have supported Brazil's universal public health care system, the Sistema Único de Saúde, where biologics rank among the highest-cost treatments. “Biosimilars contribute not only to improve access and affordability but also to a broader societal well-being by strengthening the health care system, supporting innovation, and fostering economic development,” he said, noting that biosimilar development has also helped build local manufacturing and regulatory capacity in Brazil.
Millan outlined WHO's Global Platform for Access to Childhood Cancer Medicines, established with St. Jude Children's Research Hospital, UNICEF, and the Pan American Health Organization acting as procurement agents. The platform, backed by a $200 million commitment from St. Jude, supports a broader initiative aiming to raise childhood cancer survival rates above 60% globally by 2030. Millan said the platform is reaching more than 5000 children across 12 countries, with 8 more expected to join, although fragmented demand and regulatory gaps for biosimilars in many lower- and middle-income countries remain barriers to broader access.
Russell-Pavier presented a Medicines UK analysis of roughly 100 biologics expected to lose patent protection in the UK by 2032, sorted into 3 value categories based on projected sales. He said the 24 highest-value products are largely expected to attract biosimilar competition, but smaller-market biologics may not launch in the UK without clearer demand signals and reimbursement policies that recognize the broader value of expanded access rather than lowest price alone.
Panelists Call for Regulatory Alignment
Wolff-Holz pointed to growing international convergence in biosimilar regulation. She noted that a reflection paper adopted in Europe earlier this year enabled the first biosimilar monoclonal antibody approval under a tailored development pathway requiring less clinical data, while interchangeability determinations remain a legal distinction unique to the US. “We need a balanced ecosystem with proportional, science-based regulation, sustainable pricing, faster uptake, and multisupplier procurement and predictable market access,” she said.
Rao said regulatory capacity gaps and patent barriers continue to slow biosimilar competition in the global south, even when scientific evidence supports a product's approval. She called on governments to apply reliance pathways rather than repeat redundant trials, use flexibilities under the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights to resist patent evergreening, and strengthen pharmacovigilance to build trust in biosimilars. Rao said a lower price does not guarantee that a prescribed dose will be reliably available, adding that health systems need multiple suppliers and stable procurement to guarantee continuity of treatment.
Development Gap Persists Despite Growing Savings
Randazzo closed the discussion by returning to a persistent gap between patent expirations and biosimilar development. He cited a February 2025 IQVIA Institute analysis that found 118 biologics are expected to lose patent protection in the US between 2025 and 2034, representing an estimated $232 billion opportunity, yet only 12 of those molecules had biosimilars in development as of mid-2024.3 Panelists did not reach consensus on a single policy fix for the gap but pointed to predictable regulatory pathways, multiwinner procurement that rewards supply reliability over lowest price alone, and continued international collaboration as ways to encourage further investment.
Rao offered a closing thought for the panel. “The future value of biosimilars will not be measured by approvals alone,” she said. “Achieving this requires a system we build together: science-based regulation, disciplined patent examination, sustainable procurement, diversified manufacturing, multisupplier markets, and patients involved from the beginning.” Russell-Pavier added that health systems should treat biosimilar competition as foundational rather than a niche concern. “If there is a biosimilar void that breaks down, then we can't pay for new innovation and we can't pay for widened access, and that's everybody's problem,” he said.
Some of that work is already in motion. Russell-Pavier said Medicines UK will spend the coming months working with England's National Institute for Health and Care Excellence (NICE) on a streamlined process for reassessing off-patent medicines, which could extend biosimilar use to more patients and indications, and that NICE has signaled willingness to pilot the approach in early 2027. Cox planned to follow up on the UK's extended reimbursement criteria for biosimilars with an eye toward a similar model in Canada. A recording of the webinar is expected to be posted on the Global Biosimilars Week website.
Across countries and sectors, the panelists returned to a common theme: the value of biosimilars depends as much on the policies and procurement systems built around them as on the medicines themselves.
References
- IQVIA Institute for Human Data Science. Assessing the biosimilar void in the US. IQVIA. February 3, 2025. Accessed October 22, 2026. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/assessing-the-biosimilar-void-in-the-us
- Biosimilars Council, Association for Accessible Medicines. 2025 U.S. Generic & Biosimilar Medicines Savings Report. Biosimilars Council. September 3, 2025. Accessed October 22, 2026. https://biosimilarscouncil.org/resource/2025-generic-biosimilar-medicines-savings-report/
- British Columbia Ministry of Health. B.C.'s biosimilars initiative: a report on patient and financial impact. Government of British Columbia. June 14, 2024. Accessed October 22, 2026. https://news.gov.bc.ca/releases/2024HLTH0081-000927
