Lannett starts phase I trial for insulin glargine biosimilar in South Africa

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Lannett starts phase I trial for insulin glargine biosimilar in South Africa

Biosimilars/News | Posted 02/08/2019 0 Post your comment

US generics maker Lannett Company (Lannett) announced on 5 June 2019 that it had started a phase I clinical trial of its candidate insulin glargine biosimilar.

Lannett has co-developed the product with its strategic alliance partners within the HEC group of companies (HEC), including China-based Yichang HEC Changjiang Pharmaceutical (Yichang) [1]. This trial, which is being carried out in South Africa, is part of the company’s effort to file a biosimilar biologics license application (BLA) with the US Food and Drug Administration (FDA).

Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

Lannett/HEC’s trial is a single-centre, single-dose, double-blind, randomized, two-period crossover study. The aim of the trial is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of the candidate insulin glargine biosimilar versus the US-approved originator insulin glargine, Lantus. A total of 24 healthy male adult volunteers will receive a single subcutaneous dose. In addition, a secondary objective of the trial is to assess the safety profiles of the Lannett/HEC-insulin glargine compared to US-Lantus after single subcutaneous doses.

Lannett expects study results in September 2019.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Lannett to co-develop biosimilar insulin product with Chinese partner [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 1]. Available from: www.gabionline.net/Pharma-News/Lannett-to-co-develop-biosimilar-insulin-product-with-Chinese-partner

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Source: Lannett