Sandoz Receives EC Approval of Ondibta (Biosimilar, Lantus and SoloStar)
Shots:
- The EC has approved Ondibta, a biosimilar insulin glargine pre-filled pen, reference medicine Lantus and SoloStar, developed and registered by Gan & Lee Pharmaceuticals, anticipated launch by early 2027
- Ondibta is approved for treating diabetes mellitus in pts (age≥ 2 yrs.) and matches Lantus, SoloStar in safety, quality, and efficacy
- In Dec 2018, Sandoz partnered with Gan & Lee to commercialize biosimilar insulins (glargine, lispro, and aspart), with Sandoz handling commercialization across Europe & key territories and Gan & Lee overseeing development, registration, manufacturing, and supply
Ref: Sandoz | Image: Sandoz | Press Release
Related News: Gan & Lee Pharmaceuticals Gains the CHMP’s Positive Opinion for Ondibta (Biosimilar, Lantus SoloStar)
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