By Fineline Cube 
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced that the European Medicines Agency (EMA) has issued a positive opinion from its Committee for Medicinal Products for Human Use (CHMP) on the company’s Insulin Glargine Injection, marketed under the brand name Ondibta. The CHMP recommendation paves the way for the European Commission (EC) to grant a marketing authorization for Ondibta as a biosimilar to Sanofi’s Lantus SoloStar.
Product Overview
| Attribute | Details |
|---|---|
| Product name | Ondibta (Insulin Glargine Injection) |
| Therapeutic class | Basal, long‑acting insulin (GLP‑1‑independent) |
| Indication | Diabetes mellitus (type 1, type 2, and pediatric ≥ 2 years) |
| Dosing | Once‑daily subcutaneous injection; 24‑hour glucose‑lowering effect |
| Key pharmacology | Peak‑less, stable plasma concentration; smooth glucose control |
| Biosimilarity | Compared with Sanofi’s Lantus SoloStar (EU reference) |
Market Context
- Sanofi’s dominance: In 2024, Sanofi generated €2.855 bn (≈ US$2.989 bn) in global sales of its insulin glargine product, with €819 m (≈ US$857 m) coming from Europe.
- European insulin market: Valued at ≈ €5 bn in 2024, with biosimilars expected to capture 10‑15 % of the market by 2028, driven by cost‑containment pressures and expanding pediatric use.
- Pricing outlook: Early‑stage EU biosimilar pricing suggests a 15‑20 % discount versus originator, potentially delivering €120‑150 m in incremental revenue for Gan & Lee if a 5 % market share is achieved.
Regulatory Milestones
| Date | Event |
|---|---|
| 14 Nov 2025 | CHMP issues positive opinion on Ondibta (biosimilar to Lantus SoloStar) |
| ~ Dec 2025‑Jan 2026 | Expected EC decision on marketing authorization |
| Q2 2026 | Anticipated commercial launch in EU member states (subject to EC approval) |
| 2027‑2028 | Planned rollout in additional markets (UK, Canada, Japan) under separate regulatory pathways |
Strategic Implications
- Diversification of revenue: Ondibta adds a non‑Chinese, high‑margin biosimilar to Gan & Lee’s pipeline, reducing reliance on domestic oncology assets.
- Global footprint: Successful EU approval will give Gan & Lee a foothold in the regulated Western insulin market, facilitating future cross‑border partnerships.
- Cost‑advantage positioning: As a biosimilar, Ondibta can be priced competitively, appealing to national health services and private insurers seeking lower‑cost basal insulin options.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the timing of regulatory approvals, market entry, and revenue expectations for Ondibta. Actual results may differ due to regulatory outcomes, competitive actions, pricing negotiations, and other risks disclosed in Gan & Lee’s most recent annual report and filings.-Fineline Info & Tech