Insulin Biosimilars: The Promise of Increased Access and Affordability

The global insulin market has seen tremendous growth over the past few decades driven by rising prevalence of diabetes. However, the high costs of branded insulin have left many patients unable to afford life-saving treatment. Biosimilar insulins promise to address this access challenge by providing more affordable treatment options. In this article, we explore the potential of insulin biosimilars to transform diabetes care.

What are Biosimilar Insulins?

Insulin biosimilars are biologic medicines that are highly similar to existing branded insulin products known as reference products. They are developed after the patent of the reference product expires. Though biosimilars are not generic copies of their originator products like small molecule generic drugs, they undergo rigorous clinical testing to demonstrate similarity in quality, safety and effectiveness.

The key advantage of biosimilars is their significantly lower cost compared to reference products which allows more patients access to insulin therapy. For example, typical list prices for biosimilar insulins are 20-30% lower than their branded counterparts. While prices may still be high in some markets, biosimilars offer savings that can be reinvested for further improvements in care.

Precedents from the European Union

The EU has over a decade of experience with insulin biosimilars and their uptake has progressively increased access. Insulin glargine, the first biosimilar insulin introduced in 2006, saw price reductions up to 30% compared to Sanofi’s Lantus. Similarly, biosimilar insulin degludec launched in 2019 at a 20% lower list price than Novo Nordisk’s Tresiba.

A 2016 study reviewing insulin markets in 6 EU countries found that increased biosimilar competition led to average price reductions of 15-35% for reference products. This saved healthcare systems over $100 million annually while allowing more patients to start or stay on insulin treatment. The success in EU demonstrates biosimilars can deliver cost savings without compromising quality or safety of care.

Challenges in U.S. Market Approval and Adoption

Despite the promise of lower costs, approval and adoption of insulin biosimilars has lagged considerably in the United States. Major challenges include lengthy approval timelines at the FDA owing to its conservative stance on approvals until 2015. Manufacturers also face patent thickets and anti-competitive behaviors like “pay for delay” settlements engaged in by the big insulin brands to delay biosimilar competition.

However, there is now growing momentum with the FDA approving the first U.S. insulin glargine biosimilar, Semglee, in 2019 and interchangeable insulin glargine, Mylan’s Hikma, in 2022. The Inflation Reduction Act addresses anti-competitive tactics and provides incentives that may accelerate uptake. Over 20 additional insulin biosimilars are in the works which could benefit millions of patients. Widespread adoption will depend on educating physicians and patients about interchangeability.

Optimizing Access and Affordability with Biosimilars

For insulin biosimilars to realize their full potential in enhancing access, concerted efforts are needed across the healthcare ecosystem. Pharmacy benefit managers and insurers must increase biosimilar utilization targets and adopt automatic substitution policies. Providers need education on appropriate prescribing of biosimilars without compromising quality of care.

Manufacturers must ensure stable supplies and competitive pricing to drive uptake. But governments also have a role via policy interventions like reference pricing to encourage biosimilar selection. Nations like India have shown how strategic pricing of biosimilars at 50-80% discount to reference products can transform diabetes care.

Conclusion

As the diabetes epidemic grows worldwide, biosimilar insulins offer an important opportunity to expand access to millions left unable to afford treatment. Early signs from EU and more recently the US point to their ability to deliver significant cost savings. With coordinated efforts across stakeholders and supportive policies, biosimilars can help address one of the most pressing challenges facing diabetes management globally.