Insulin glargine (Sanofi)

Patients that use rapid-acting insulin to help control their blood sugar spikes have a biosimilar option in Sanofi's Merilog, which has gained FDA approval. More than three years after approving two biosimilars referencing Sanofi’s long-acting insulin Lantus, the FDA has signed off on a rapid-acting insulin biosimilar for the first time.The agency has given a thumbs up to Sanofi’s Merilog (insulin-aspart-szjj) as the first biosimilar to Novo Nordisk’s NovoLog for patients with diabetes. Insulin aspart is delivered by a subcutaneous shot 5 to 10 minutes before mealtime to help patients control glucose and limit blood sugar spikes.Merilog will be provided by prefilled pen in a 3 mL dose or in a multiple-dose 10 mL vial. It is for adults and pediatric patients age 6 and older.The approval is backed by a phase 3 trial of 597 patients with type 1 and type 2 diabetes who received multiple shots daily. At week 26, blood sugar levels were similar for those who received the biosimilar and those on the reference product, confirming Merilog’s non-inferiority.Of the roughly 38 million in the U.S. with diabetes, 8.4 million use either a rapid-acting or long-acting insulin, or both, the FDA said. The high cost of insulin has led some patients to ration their use, triggering high-profile calls from U.S. lawmakers for companies to drop their prices.In 2023, Eli Lilly revealed a plan to cut the cost of most of its insulins by 70%. Less than two weeks later, Novo Nordisk announced a planned 75% reduction in the cost of NovoLog.Then a few days later, Sanofi followed suit with a 78% slashing of the price of Lantus. The company also said it would cap the monthly out-of-pocket cost for Lantus at $35 for those with commercial insurance.  NovoLog and Novo Nordisk’s other rapid-acting insulin follow-on Fiasp are among the drugs subject to government price negotiations under the Inflation Reduction Act. The new prices will be enacted at the start of next year.In July 2021, the FDA approved Biocon and Viatris’ Semglee (insulin glargine-yfgn) as the first biosimilar to Lantus. Five months later, the U.S. regulator endorsed Eli Lilly’s version of the drug, called Rezvoglar (insulin glargine-aglr).

On January 23, HengRui Pharma announced that the application for the marketing authorization of Shudi Insulin Injection (INS068) has been accepted by the National Medical Products Administration. This product marks the first self-developed long-acting insulin analogue in China. The marketing application is primarily based on positive results from two pivotal Phase III clinical trials (Studies 301 and 302). These trials assessed the efficacy and safety of Shudi insulin injection compared to glargine insulin in adults with type 2 diabetes mellitus (T2DM) who had poor glycemic control while on basal insulin or oral hypoglycemic agents. The 301 study enrolled 423 participants, while the 302 study included 513 participants. Both studies were successfully completed in December 2024. Results showed that after 26 weeks of treatment, Shudi insulin maintained a similar reduction in glycated hemoglobin (HbA1c) compared to glargine insulin, whether used alone or in conjunction with oral hypoglycemic agents. Moreover, the safety and tolerability profiles of Shudi insulin were favorable, with adverse events resembling those of glargine, and incidences of hypoglycemia, particularly nocturnal hypoglycemia, slightly lower than those observed with glargine. Both studies met their primary endpoints. Diabetes is a metabolic syndrome characterized by high blood sugar levels due to insulin secretion defects and/or inadequate insulin action. In 2021, the global population of diabetics reached 537 million, with approximately 140 million cases in China, making it the country with the highest number of diabetes patients. Projections indicate that by 2045, the global count may rise to 783 million, with China accounting for 170 million. T2DM constitutes over 90% of all cases, primarily resulting from insulin resistance and progressive decline in pancreatic β-cell function. If left uncontrolled or poorly managed, high blood sugar can lead to irreversible vascular complications, including retinopathy, renal failure, myocardial infarction, stroke, and amputation. The treatment of T2DM currently employs a comprehensive management model that includes dietary control, exercise, blood sugar monitoring, diabetes education, and pharmacotherapy. Lifestyle interventions serve as foundational treatment measures, and as T2DM progresses, it often necessitates a combination of different classes of hypoglycemic agents. Clinical guidelines recommend initiating insulin therapy when blood sugar levels remain uncontrolled after treatment with one or more oral agents. For newly diagnosed T2DM patients exhibiting significant hyperglycemic symptoms or ketosis, a short-term insulin intensification regimen is the preferred option. Shudi insulin injection is HengRui Pharma's self-developed long-acting insulin, characterized by its steady onset, prolonged duration of action, and lower risk of nighttime hypoglycemia. To date, approximately 34.88 million yuan has been allocated to the development of Shudi insulin-related projects. Globally, similar products have already received approval, including Novo Nordisk's Tresiba® and Sanofi's Toujeo®. According to the Nextpharma database, global sales of Tresiba® and Toujeo® combined reached $2.3 billion in 2023.