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Lannett Reports the First Patient Dosing in the Pivotal Clinical Trial of Biosimilar Insulin Glargine

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Lannett Reports the First Patient Dosing in the Pivotal Clinical Trial of Biosimilar Insulin Glargine

Shots:

  • The first patient has been dosed in the pivotal clinical trial of biosimilar insulin glargine across South Africa. The biosimilar is being co-developed with its strategic alliance partners within HEC & the results are expected at the end of 2022
  • The first study was reviewed by the US FDA which recommended that the Lannett/HEC insulin glargine product would be biosimilar to Sanofi’s Lantus by meeting the PK & PD EPs of the trial. Additionally, clinical material manufactured at a commercial scale in a new insulin facility will be used for the pivotal trial
  • If successful, the company will file the BLA in early 2023 & the product is expected to be launched in H1’24, if approved

Ref: PR Newswire | Image: Lannett

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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