The Rise of Biosimilars
Diabetes is a chronic disease affecting millions worldwide. One of the most common treatments is insulin therapy which sees rising costs year-on-year. This has led to the development of biosimilar insulins which aim to provide more affordable treatment options. Biosimilars are biologic medicines that are developed to be highly similar to an already approved biologic product, known as the reference product.
Regulatory Approval Process
To gain regulatory approval, biosimilars undergo a rigorous evaluation process to demonstrate their safety and efficacy is highly similar to the reference product. The reference product for insulin is human insulin which was first approved in 1982. Data from analytical, animal and clinical studies are submitted to top drug regulators like the US Food and Drug Administration and European Medicines Agency for review and approval. They ensure biosimilars meet the same quality, safety and efficacy standards as reference products before approval.
Cost Savings Potential
With patented biologics losing exclusivity, biosimilars provide an opportunity for greater competition and cost savings. Estimates show biosimilars could save the US healthcare system over $54 billion over the next decade. For patients, average annual savings per drug will be $2,784 for insulin biosimilars. Savings may be passed on through lower list prices or discounts for payers like insurance plans. This substantially improves access and adherence to treatment among diabetics from all socioeconomic backgrounds.
Pipeline of Insulin Biosimilars
With the lucrative US insulin market and patent expiries of insulin glargine and degludec looming, several biosimilar developers are progressing their programs. Semglee by Mylan was the first biosimilar insulin glargine approved by the FDA in 2020. Insulin lispro and human insulin biosimilars are also in late-stage trials. Other notable programs in Phase III trials include basaglar follow-ons from Fresenius Kabi, Coherus and BI. These are assessing their interchangeability, similar efficacy, safety and ability to produce identical clinical results to reference insulins.
Transitioning Patients to Biosimilars
Successful transitioning of patients from originator insulins while maintaining glycemic control is crucial. Biosimilar uptake will depend on physician and patient confidence. Educating healthcare professionals and patients on the rigorous approval process and demonstrating real-world evidence is key. Specialist diabetic physician groups are developing guidelines for switching between reference and biosimilar insulins. Regional diabetes coalitions aim to transition high volumes through coordinated efforts. With buy-and-bill specialty pharmacy models dominating US insulin distribution, uptake may be gradual as standard treatment protocols adapt.
Reimbursement Environment
Reimbursement models will largely determine whether cost savings from biosimilars are realized by payers or pocketed by manufacturers and distributors. Many US payers now favor formulary inclusion of biosimilars. Medicare also promotes greater biosimilar adoption. But insurers tend to pass on minimal savings to patients with high deductible plans. Successful initiatives in EU nations with centralized healthcare illustrate potential cost savings to the system, when policies drive uptake and mandate price referencing to reference products.
Future Outlook
As the insulin biosimilar market matures, companies will compete on widening product portfolios, clinical differentiation and value-added services to pharmacy benefit managers. Interchangeability approvals will strengthen automatic substitution of biosimilars at pharmacy level. The generics route could see insulins reclassified and dispensed as substitutable medicine. With more affordable biosimilars available and competitive pressures, reference insulin prices may reduce gradually as well. This will help transform diabetes management by making life-saving insulin accessible to all in need.
