Biocon Received Approval in India for its Liraglutide Drug Substance

• Biocon Limited received Indian regulatory approval for its Liraglutide drug substance.
• Biocon Pharma Limited secured approval for its generic Victoza injection product for Type 2 Diabetes treatment in patients aged 10 and above.
• Approval was granted under the CDSCO’s new 101 route, recognizing approvals from stringent global regulatory authorities.

Biocon Limited, a global biopharmaceutical company focused on innovation, announced today that its Liraglutide drug substance has been approved in India. In addition, Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has secured approval for its Liraglutide drug product (6mg/ml solution for injection in prefilled pens and cartridges) from the Drugs Controller General of India, CDSCO.

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This approval covers the generic version of Victoza indicated for inadequately controlled Type 2 Diabetes Mellitus in adults, adolescents, and children aged greater than or equal to 10 years of age used in conjunction with diet and exercise. The CDSCO approved this approval through the newly introduced 101 route that permits recognition of approvals from recognized and established stringent regulatory authorities.

“The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further. The approval enables us to address a critical need by making this drug available, and aligns with Biocon’s mission to provide affordable, lifesaving medications to those who need it the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India,” said Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon Ltd.