Global Regulatory Gridlock Hinders Biosimilar Savings, Expert Panel Warns

To continue coverage during Global Biosimilars Week, a recently published international qualitative study highlighted deep-rooted inconsistencies in international approval pathways that are imposing unnecessary development delays and increased expenses on biosimilar medicines.¹

The fragmented global regulatory landscape, the study finds, is prompting an expert panel to issue 16 high-consensus recommendations aimed at fostering global regulatory convergence and speeding up access to these essential cost-saving therapies.

A recent study reveals global regulatory inconsistencies in biosimilars, urging convergence to enhance access and savings for patients and health care systems. | Image credit: Drazen - stock.adobe.com

The investigation, which focused on the global biosimilar approval process, sought to understand why varying regulatory requirements—such as those related to reference product selection and local clinical data—continue to force manufacturers into conducting duplicate, scientifically unjustified clinical trials. This prolonged process unnecessarily inflates development costs and slows the entry of cost-effective alternatives to the global market, undermining savings for managed care organizations and delaying access for people who rely on biologics.

Consensus Built Among Global Stakeholders

The study utilized a modified Nominal Group Technique, which is designed to quickly build consensus among experts. The process involved 3 structured phases: initial grading, focused discussion sessions, and final grading.

The international panel comprised 21 participants (two academics, seven regulators, and 12 industry representatives) who gathered in 4 focus groups in September 2023. The authors focused solely on the perspectives of development and approval experts and did not include input from policymakers, payers, or the people who receive these medicines.

Top Recommendations Target Scientific Reliance

The panel initially proposed 22 distinct recommendations, with 16 ultimately securing a high consensus, defined as achieving at least 80% agreement and a weighted mean score of 4.0 or higher out of 5.0.

The highest-rated recommendations clearly pointed toward non-clinical, foundational fixes to the existing regulatory framework. Tied for the top score (4.65/5) were recommendations focused on Reliance and Convergence and Stakeholder Education.

For the former, the panel strongly advised that regulatory bodies promote convergence by leveraging the assessment and approval decisions made by established, stringent regulatory authorities (like the FDA or European Medicines Agency). By relying on external reviews, jurisdictions can avoid redundant work and speed up local approvals. Concurrently, experts stressed the need to enhance education on science-based biosimilarity principles among all stakeholders, ensuring that approval decisions are based on the latest analytical advancements rather than outdated, conservative policies.

Close behind, with a score of 4.60/5, was the recommendation for Modernizing Requirements, with high agreement on aligning regulatory requirements with current scientific knowledge, particularly when considering the necessity of comparative clinical efficacy studies. Modern analytical methods often provide sufficient data, making exhaustive clinical trials scientifically unnecessary. On the other end of the spectrum, the panel registered low consensus (mean score: 2.80/5) for offering incentives to develop new pharmacodynamic biomarkers, suggesting that the clinical viability of that approach remains uncertain.

Inconsistent Rules Are Costly

The authors noted that requirements characterized by national variations—such as demanding a local reference product or a local clinical study—are rooted in regulatory conservatism rather than modern scientific evidence. These costly requirements are ultimately passed down to global health care systems.

The authors summarized the challenge, stating that the current regulatory structure is counterproductive: “These divergences are often intended to maintain national sovereignty through independent decision-making, but they often suffer from disparities in regulatory capacity, thereby hindering global regulatory convergence.” The findings suggested that many current regulatory requirements stem from outdated legislation that has not kept pace with the scientific advancements achieved in modern biosimilar manufacturing.

A Roadmap for Global Efficiency

As a qualitative, consensus-based report, the study is limited in that its recommendations rely on expert opinion rather than quantitative, real-world cost-saving data. Additionally, the small panel size of 21 people may not capture the breadth of global regulatory experience.

By embracing regulatory reliance and focusing on educational initiatives, global collaboration can dismantle these unnecessary roadblocks, fostering a more efficient biosimilar development pathway that accelerates patient access and delivers greater cost savings across managed care.

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