Nonclinical pharmacology and toxicology of the first biosimilar insulin glargine drug product (BASAGLAR® /ABASAGLAR® ) approved in the European Union

Regulatory Toxicology and Pharmacology : RTP
Richard A ByrdJohn L Vahle

Abstract

Basaglar®/Abasaglar® (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus® (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We assessed the similarity of LY IGlar to the reference drug product, European Union-sourced SA IGlar (EU-SA IGlar), using nonclinical in vitro and in vivo studies. No biologically relevant differences were observed for receptor binding affinity at either the insulin or insulin-like growth factor-1 (IGF-1) receptors, or in assays of functional or de novo lipogenic activity. The mitogenic potential of LY IGlar and EU-SA IGlar was similar when tested in both insulin- and IGF-1 receptor dominant cell systems. Repeated subcutaneous daily dosing of rats for 4 weeks with 0, 0.3, 1.0, or 2.0 mg/kg LY IGlar and EU-SA IGlar produced mortalities and clinical signs consistent with severe hypoglycaemia. Glucodynamic profiles of LY IGlar and EU-SA IGlar in satellite animals showed comparable dose-related hypoglycaemia. Severe hypoglycaemia was associated with axonal degeneration of the sciatic nerve; the incidence and severity were low and did not differ between LY IGlar and EU-SA IGlar. These results dem...Continue Reading

Citations

Sep 19, 2019·Cadernos de saúde pública·Bruna de Oliveira AscefPatrícia Coelho De Soárez
Jan 4, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Robyn K PollomRamón Ortiz Carrasquillo
Feb 14, 2018·Diabetes Technology & Therapeutics·Thomas DanneJan Bolinder
May 26, 2018·Therapeutic Advances in Endocrinology and Metabolism·Torben BiesterThomas Danne

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