Sandoz Partner Gan & Lee Wraps Phase III Insulin Glargine Trial
Follows Earlier Positive Phase I Clinal Data For Biosimilar Rival To Lantus
Sandoz’ partnership with China’s Gan & Lee covering three biosimilar insulin products continues to make progress, with the conclusion of a pair of Phase III trials involving a proposed biosimilar to Lantus (insulin glargine).
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Lannett has delivered on its promise of kicking off a pivotal clinical trial for its proposed interchangeable biosimilar rival to Lantus by the end of March, as it eyes a 2023 filing and 2024 launch in the US for the insulin glargine product on which it has partnered with HEC.
Lannett says it is ready to kick off the pivotal clinical trial for the biosimilar insulin glargine candidate it is developing with HEC, after the US FDA completed the safety review of the product’s investigational new drug application.
Sandoz has filed the proposed trastuzumab biosimilar developed by partner EirGenix with the US FDA. If approved, the product will have to compete in an already busy market for Herceptin biosimilars.