Gan & Lee Pharmaceuticals and its European subsidiary Gan & Lee Pharmaceuticals Europe GmbH announced that Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of insulin glargine injection (pre-filled pen) (brand name: Ondibta®?) for treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above, as biosimilar to the reference medicine Lantus®? SoloStar®?. Insulin glargine injection is a long-acting insulin analog, also known as a basal insulin analog.
It is injected once daily, and after the onset of action, its effect can last for 24 hours. Insulin glargine has a long duration of action, a peakless plasma concentration, and can steadily lower the blood glucose level. To date, Gan & Lee's insulin glargine injection (brand name Ondibta®?") is the first and only insulin glargine product developed in China to have completed head-to-head Phase III clinical studies in both Europe and the United States against Sanofi's reference product, Lantus®?.
The's pivotal studies, involving over 1,100 patients with diabetes (approxima tely 570 with T1DM and 580 with T2DM), demonstrated thera peutic biosimilarity between Ondibta®? and the reference medicine in terms of efficacy and safety. Furthermore, using the glucose clamp technique, the gold standard for evaluating insulin pharmacokinetics and pharmacodynamics, Gan & Lee has also conducted and completed a head-to-head clinical study comparing its insulin glargine U300 with the reference product Toujeo®?, confirming their biosimilarity in efficacy and safety.
As a classic long-acting basal insulin with over two decades of clinical use and extensive worldwide, Ondibta®? has accumlated substantial pre-approval clinical evidence and post-marketing real-world evidence, earning broad recognition and long-term trust among physicians and patients globally. Gan & Lee's insulin gl Targine (Ondibta®?) is poised to enter the EU market for commercialization, providing European patients with a new, high-quality treatment option and contributing positively to the overall advancement of diabetes care and management in the region.
As of the date of announcement, in the European region, the main supplier of insulin glargine injection is Sanofi. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin®?), fast-acting lispro injection (Prandilin??), fast-acting aspart injection (Rapilin®?), mixed protamine zinc lispro injection (Pr andilin??25), aspart 30 injection (Rapilin®®?30), and one human insulin injection - mixed protamine human insulin injection (Similin®?30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®?).
In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (Gan LeeFine®?).
