Sandoz and Gan & Lee, Bysumlog, a biosimilar of Lispro insulin, approved in the EU
Partnership since 2018 leads to EU approval
The European Commission (EC) granted marketing authorization for Bysumlog (insulin lispro) on May 6, 2026. This is the final regulatory decision following the positive opinion adopted by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on February 26, corresponding to the Approval stage. Gan & Lee Pharmaceuticals (603087.SH) is responsible for the development, manufacturing, and supply, while Sandoz Group AG (SDZ) handles commercialization in Europe and key international markets. The partnership, initiated in December 2018 for Glargine, Lispro, and Aspart insulins, has now led to the consecutive EU approvals of Ondipta, Bysumlog, and Dazpada in 2026, completing a portfolio that covers both basal and mealtime insulins.
Target and indication same as Humalog
The active ingredient of Bysumlog is insulin lispro, which activates insulin receptors in muscle and fat cells to promote glucose uptake and inhibit glucose release from the liver. It is a 100 units/ml ultra-rapid-acting biosimilar referencing Eli Lilly and Company's (LLY) Humalog (insulin lispro), approved for adult and pediatric diabetes and early blood glucose stabilization. Humalog was approved in the EU on April 30, 1996, and Gan & Lee estimates the global 2024 sales of Humalog-class insulin lispro at USD 2.325B. Bysumlog competes with both the originator Humalog and Sanofi's insulin lispro, as well as NovoRapid and Fiasp, which are standard-of-care insulin aspart for mealtime insulin.
Phase 1 bioequivalence was key to approval
The clinical evidence included a randomized, double-blind, three-period crossover Phase 1 trial (NCT04235439) involving 38 healthy men. The trial compared the candidate GL-LIS 0.2 U/kg of Bysumlog with EU- and US-approved Humalog using a 12-hour euglycemic clamp method. The ratio of key pharmacokinetic (PK) and pharmacodynamic (PD) parameters was close to 100%, with confidence intervals within the pre-specified bioequivalence range of 80–125%, and no serious adverse reactions occurred. EMA recognized the high similarity in structure, purity, biological activity, and in vivo exposure, and granted full indication approval without requiring additional confirmatory efficacy trials, relying on the accumulated evidence from insulin biosimilars.
Market entry depends on pricing and tender competition
The European insulin market was valued at USD 4.080B in 2024 and is projected to reach USD 4.665B by 2030, with a CAGR of 3% from 2025 to 2030. In Europe, the number of diabetes patients aged 20–79 is expected to rise from 66 million in 2025 to 72 million in 2050, with related healthcare costs reaching approximately USD 200B, highlighting the growing policy demand for low-cost insulin. However, product launch depends on passing country-specific pricing, reimbursement, and hospital tender approvals, so approval alone does not guarantee immediate revenue. Sandoz's distribution and tender capabilities, along with Gan & Lee's manufacturing and supply stability, will determine how much of Sanofi's insulin lispro supply shortage in 2026 they can capture, influencing initial market share.
The EU approval of Bysumlog allows Gan & Lee (603087.SH) to convert Phase 1 bioequivalence data into a commercial asset, while Sandoz (SDZ) secures a portfolio of basal and mealtime insulin products with Ondipta, Bysumlog, and Dazpada. In the short term, national tender and reimbursement competition in the USD 4.080B European insulin market will begin, targeting Humalog, Sanofi's insulin lispro, NovoRapid, and Fiasp. From an R&D perspective, the approval via a 38-patient Phase 1 PK/PD clamp trial and analytical similarity sets a precedent that could reduce development costs and clinical burdens for subsequent insulin biosimilars. Medium- to long-term value will depend on the number of launch countries, supply stability, discount rates, and revenue-sharing arrangements between Sandoz and Gan & Lee, rather than the 66 million diabetes patients in Europe.
Source: EMA (ema)