Strengthening Diabetes Care With Purpose-Built Data Infrastructure

Overcoming barriers to insulin access and adherence—particularly with biosimilar insulins—requires robust real-world evidence (RWE) and purpose-built data systems to improve diabetes outcomes and inform health policy, according to a review.¹

As of June 2025, there are 3 insulin biosimilars approved in the US: 2 insulin glargine (Semglee and Rezvoglar) and 1 insulin aspart (Merilog). | Image credit: Antto-AI - stock.adobe.com

The narrative literature review, published in Diabetes, Obesity and Metabolism, was conducted to address persistent challenges in realizing the full benefits of insulin therapy and to emphasize the importance of RWE in evaluating the safety, efficacy, and cost-effectiveness of biosimilar insulins. By highlighting current usage patterns, identifying critical data gaps, and proposing the development of purpose-built diabetes registers supported by trained clinical teams, the authors aim to strengthen real-world data infrastructure that can guide more equitable, timely, and effective diabetes care and policy.

As of June 2025, there are 3 insulin biosimilars approved in the US: 2 insulin glargine (Semglee and Rezvoglar)^2,3 and 1 insulin aspart (Merilog).⁴

According to the review, well-designed diabetes registers are essential for generating reliable RWE to guide clinical decisions, improve care quality, and inform health policies, especially in the use of cost-effective treatments like biosimilar insulins.¹ Unlike unstructured electronic health records (EHRs), purpose-built registers ensure consistent data collection, enabling the assessment of treatment effectiveness, safety, adherence, and health care costs. When linked with EHRs and claims data, registers can track disease progression, identify care gaps, and evaluate interventions at both patient and population levels. With regulatory bodies increasingly recognizing RWE as critical for approval and policy decisions, robust diabetes registers are key to advancing data-driven, personalized diabetes care.

Recent RWE highlights key trends in insulin use, particularly among people with type 2 diabetes (T2D). Over the past 2 decades, there has been a clear shift from insulin monotherapy to combination therapy with oral glucose-lowering drugs across multiple regions, including Japan, the US, and Italy. Although insulin use as a first-line treatment has remained stable, its use as a second-line therapy is rising. Patterns vary regionally: Japan and the US show declines or stable use, while Hong Kong and Denmark report modest increases. There’s also been a notable global shift from human insulin to long-acting and fast-acting insulin analogues, especially in high-income countries. Basal-bolus regimens are increasingly common in people with T2D, while basal-only regimens are the most common treatment option for people with T2D. Concentrated insulin formulations are also gaining traction, especially in insulin-resistant populations.

Biosimilar insulin use is rising, especially in the US and Canada, where policy mandates have driven uptake. In contrast, adoption remains modest in Europe and many parts of Asia, reflecting variability in regulation, physician preference, and market access. Despite their cost benefits, biosimilars are still underused globally. These shifts underscore the need for better data from low- and middle-income countries, where most people with diabetes live, to understand global insulin use patterns and improve equitable access.

Insulin biosimilars match originators in efficacy and safety, including in insulin pumps, but real-world use remains low due to limited awareness and uptake. Despite being up to 64% cheaper, underutilization—seen even in countries like England and Spain—has prevented full cost savings. Therapeutic inertia, fear, stigma, and system-level barriers contribute to delays in insulin initiation and poor adherence, especially in lower-income regions. Nurse-led care and tech-based support improve outcomes, but provider education and trust in biosimilars remain essential. Compatibility with smart pens and novel delivery systems is still limited, hindering broader adoption.

Insulin needs vary across diabetes subtypes. People with type 1 diabetes require lifelong insulin due to absolute insulin deficiency, and incidence is rising globally, especially in low- and middle-income countries where access remains limited. Slowly progressing autoimmune diabetes (often misclassified as T2D) also leads to insulin dependence. Type 3c diabetes, linked to pancreatic disease, typically involves insulin deficiency and complex glucose regulation. Monogenic diabetes may require insulin, depending on the mutation, while around one-third of people with T2D will eventually need insulin due to progressive beta cell loss. Insulin use in T2D varies by age, duration, and region, with young-onset and older adults particularly affected.

Despite insulin’s century-old discovery, full benefits remain unrealized due to access, cost, and care quality barriers. The authors said that optimizing insulin use will require comprehensive phenotyping, timely initiation, and individualized management supported by education, monitoring tools, and emerging biosimilar options that may improve affordability and access.

The authors concluded, “Scientific evaluation with regulatory approval is critical in ensuring the quality of these technologies; it is here where diabetes registers implemented by a trained doctor–nurse team with system support can become an invaluable tool to assess the impacts of these technologies on clinical outcomes, quality of life and health care costs to inform practice and policies.”

References

1. Yang A, Yu J, Cheung JTK, Chan JCN, Chow E. Real world evidence of insulin and biosimilar insulin therapy—opportunities to improve adherence, outcomes and cost-effectiveness. Diabetes Obes Metab. Published online April 15, 2025. doi:10.1111/dom.16386.

2. Hagen T. FDA approves Semglee insulin glargine as first interchangeable biosimilar. The Center for Biosimilars^®. July 28, 2021. Accessed June 17, 2025. https://www.centerforbiosimilars.com/view/fda-approves-semglee-insulin-glargine-as-first-interchangeable-biosimilar 

3. Rezvoglar broadens insulin glargine biosimilar options. The Center for Biosimilars. December 30, 2021. Accessed June 17, 2025. https://www.centerforbiosimilars.com/view/rezvoglar-broadens-insulin-glargine-biosimilar-options

4. Jeremias S. FDA approves first insulin aspart biosimilar. The Center for Biosimilars. February 17, 2025. Accessed June 17, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-insulin-aspart-biosimilar