EMA Recommends Approval of Sanofi's Insulin Lispro Biosimilar

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the marketing authorization of Insulin lispro Sanofi, biosimilar to Eli Lilly’s originator product insulin lispro (Humalog).

The CHMP recommended the use of Insulin lispro Sanofi (100 Units/mL) to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including patients whose diabetes has just been diagnosed. The EU is expected to make a final decision on the product’s marketing authorization in the coming months.

The CHMP’s positive decision was based on Sanofi’s clinical development program that enrolled over 1000 adults with type 1 or type 2 diabetes. The program included a pharmacokinetic/pharmacodynamics phase 1 study, which evaluated the product’s similarity in exposure and activity compared with insulin lispro 100 Units/mL as currently approved in the US and European Union (EU), and 2 multicenter phase 3a clinical trials (SORELLA 1 and SORELLA 2) that evaluated its safety and efficacy compared with insulin lispro 100 Units/mL as currently approved in the US and EU in adults with type 1 or type 2 diabetes. In addition, a safety study was conducted with the lispro biosimilar used in insulin pumps in adults with type 1 diabetes.

Insulin lispro’s patent expired in 2013 and there is no FDA-approved biosimilar version of the product in the United States. Sanofi’s insulin lispro product, SAR 342434, completed phase 3 trials in 2016. Data from the trials showed that SAR 342434 is equally safe and effective as insulin lispro plus insulin glargine in patients with type 1 diabetes. Other insulin lispro biosimilar candidates in the research pipeline are in much earlier phases of clinical trials than the Sanofi candidate.

The only FDA-approved biosimilar of an insulin product in the United States is Eli Lilly’s Basaglar, a biosimilar of insulin glargine (Sanofi’s Lantus), which was approved by the FDA in late 2015. Strictly speaking, Basaglar is not a biosimilar but rather is referred to as a “follow-on” insulin. Hormones and human growth hormones are approved by FDA under a different path than biologics because they are regulated as drugs, not biologic products.

The lower cost of biosimilar insulins is expected to increase access to insulin analogs such as insulin lispro, providing more tailored treatment and improved health outcomes for the nearly 6 million Americans with diabetes who rely on insulin. With the introduction of insulin glargine, a savings of approximately 15% off list price of brand-named insulin glargine occurred.