Insulin is a life-saving hormone used for the treatment of diabetes. Traditionally, insulin has been produced through recombinant DNA technology using bacteria or yeast. However, as patents for branded insulins expire, biosimilar versions of insulin are being developed and approved. Insulin biosimilars offer the potential for more treatment options and greater access to care for people with diabetes.
What are insulin Biosimilars?
A biosimilar is a biologic medical product that is highly similar to an already approved biologic, known as the reference product. Biosimilars contain the same active substance and have comparable safety and efficacy as the original product. To gain approval, a biosimilar must demonstrate it is highly similar to the reference product in terms of structure, function, and pharmacokinetics. Small differences in clinically inactive components are allowed in biosimilars.
The Development and Approval Process
Developing biosimilars is more complex than creating generic small-molecule drugs due to the larger, more complex nature of biologics. Extensive testing is required to demonstrate similarity of the biosimilar to the reference product. Clinical trials are usually performed to show comparable pharmacokinetics, pharmacodynamics, immunogenicity, efficacy, and safety. Approval pathways are in place at regulatory agencies like the U.S. Food and Drug Administration and the European Medicines Agency. Approval relies on comprehensive structural, functional, and clinical data showing no clinically meaningful differences versus the reference product.
Available Insulin Biosimilars
A few biosimilars have already received approval for use in certain countries. In Europe, the first insulin biosimilar to receive approval was Insulin glargine, approved in 2015 under the trade name Abasaglar. This biosimilar version references Sanofi's Lantus. Additionally, Semglee, a biosimilar to Lantus launched in 2020. Other approved European insulin include Insulin degludec biosimilar Basalog launched in 2019 and Insulin lispro biosimilar Lyxumia launched in 2021.
In the U.S., the first insulin biosimilar was also an Insulin glargine called Semglee, approved in 2019. Another Insulin glargine called Insulin glargine-yfgn launched in 2022. Insulin lispro biosimilar Follow-On insulin lispro is also approved. More insulin are expected to gain approval and expand patient access in different global markets.
Cost Savings Potential with Biosimilars
As more biosimilars gain approval, insulin treatment costs have the potential to decrease significantly. Some analyses estimate that widespread biosimilar uptake could reduce insulin spending in the U.S. by billions annually. In Europe, the entry of the first insulin glargine biosimilar led to a 15-35% decline in the average government reimbursement price. Greater competition is projected to drive prices down further over time. More affordable options may encourage increased insulin use and better diabetes control. Lower costs could also mean a greater number of individuals gain insurance coverage for chronic insulin needs.
Interchangeability and Automatic Substitution
Interchangeability and automatic substitution are key factors that influence biosimilar adoption and cost savings. An interchangeable biosimilar may be substituted for the reference product without intervention from the prescriber. In many countries, interchangeability designation allows substitution at the pharmacy counter. In the U.S., no insulin biosimilar has yet gained interchangeable status from the FDA, limiting automatic substitution. European countries generally permit automatic substitution of interchangeable biosimilars. Achieving interchangeability designation involves additional clinical testing and could accelerate uptake of less costly biosimilars in the U.S. market.
Quality Considerations
As with any medicine, the quality, safety, and efficacy of insulin biosimilars is of utmost importance. Extensive analytical, nonclinical, and clinical testing is carried out during development to demonstrate biosimilarity for regulatory approval. Post-approval monitoring also continues to ensure consistently high manufacturing and product quality standards are met. Biosimilars offer a safe and effective alternative to branded products. With appropriate regulation and pharmacovigilance, insulin biosimilars present an opportunity to improve diabetes management on a global scale.
Conclusion
The introduction of biosimilar insulins creates more options for individualizing diabetes treatment regimens while offering potential cost savings. Greater access to insulin therapy resulting from lower prices could meaningfully impact public health by reducing diabetes-related complications. As the biosimilar market evolves, increased interchangeability and automatic substitution may drive biosimilar use and maximize budgetary impacts. Overall, biosimilars present an encouraging development for making life-saving insulin therapy more affordable and sustainable worldwide.
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