Drugmaker Wockhardt has approached the Drug Controller General of India (DCGI) seeking approvals for its fast-acting insulin analog, Aspart injection.
The company’s Aspart insulin injection (ASPARAPIDTM) is indigenously developed, reflecting its end-to-end capabilities in research and development, clinical studies, scale-up and manufacturing of biosimilars products, the company said in a statement.
Insulin Aspart is a rapid-acting product originally from multinational Novo Nordisk and is sold globally as NovoLog or NovoRapid. However, locally developed products are gaining in significance, since India has the second largest number of people with diabetes in the world. Last year, drugmaker USV said it had partnered with biotech venture Biogenomics to bring out InsuQuick, the first locally-made biosimilar version of Insulin Aspart.
Wockhardt is also developing additional insulin analogs and GLP-1 agonists as part of its comprehensive strategy to provide advanced diabetes care solutions, the company said.
“By leveraging integrated infrastructure and expertise, Wockhardt has completed all stages of ASPARAPIDTM development - from research to production through in-house development,” the company said. Further, it pointed out, “ASPARAPIDTM will be available in cartridges, vials, and prefilled disposable pens, offering flexibility to the patients for management of diabetes.” The market for Aspart in India is estimated at ₹260 crore, with limited participants.
“We are proud of adding another feather in our diabetes biosimilars portfolio through filing of insulin Aspart injection in a market that has limited competition. This reinforces Wockhardt’s ability to develop and manufacture complex biosimilars domestically,” said Dr Habil Khorakiwala, Founder Chairman of Wockhardt. “Our aim is to make world-class diabetes care accessible to patients in India and globally and to contribute meaningfully to the management of diabetes,” he added.