Shots:

• The US FDA have completed the safety review of the IND application for biosimilar insulin glargine. The FDA has stated that the company will proceed the clinical trial which is expected to be start in Mar 20222 across South Africa and completed by early 2023
• The trial will be conducted using the proposed final to-be-marketed formulation of the Lannett/HEC biosimilar insulin glargine while the company have received the regulatory clearances in the US and South Africa to conduct the study
• The company will initiate the doing of patients in Q1’22 & will file the BLA in early 2023, if the trial is successful. The product is expected to be launch by early 2024, if approved

Ref: PR Newswire | Image: IBPS Consulting