SEC recommendation in accordance with guidelines: Biocon Biologics

Biocon Biologics not only denied allegations of bribery, but said that the rationale for waiving phase-3 clinical trials for its Insulin Aspart injection was based on Indian regulatory guidance.

The company said its product approvals are backed by science and clinical data, and the rationale for waiver was based on the Similar Biologics Guidelines, 2016, and New Drugs and Clinical Trials, 2019.

“The guidelines provide a framework for waiver of phase-3 clinical trials to be conducted in India based on a commitment to undertake a phase-4 trial, the design of which should be approved by the Central Licencing Authority. In line with