Regenix puts TN on India’s biosimilar map with Sustaglar insulin facility

CHENNAI: Tamil Nadu has entered the elite league of biosimilar insulin manufacturers, with the city-based Regenix Drugs commissioning the State’s first facility and only the fifth in India. Its flagship product, Sustaglar, a long-acting glargine insulin, aims to make diabetes treatment more affordable and accessible, particularly in rural markets.

Regenix, which traces its roots back to 1996, began by supporting doctor-entrepreneurs struggling to run hospitals, pharmacies and diagnostic centres. After selling its first pharma venture in 2006, the promoters set up Regenix Drugs Ltd in 2007-08. “Today, we run 104 pharmacies and 35 diagnostic centres across Tamil Nadu, with a pharmaceutical business spanning 200 formulations and 500 field staff,” says Dr A Ramamurthy, chairman and managing director, Regenix.

The decision to enter biosimilars, according to him, was driven by the growing burden of diabetes, with over 100 million Indians diagnosed and another 30 million in pre-diabetic stages. “Diabetes being a major killer disease in India and world over, we started selling oral anti-diabetic drugs. Insulin, the only drug that survived 100 years and continues to grow, fascinated us. Unlike conventional insulin, the Sustaglar (glargine), analogue insulin, a biosimilar, attracted us because one dose per day controls blood sugar in 50 per cent of type2 diabetes, with less peak and less hypoglycaemia. We felt the need to offer a more affordable, patient-friendly version, especially as multinational players’ price newer analogues steeply,” he said.

Sustaglar mimics the body’s basal insulin secretion and helps preserve pancreatic beta cells, which in turn prevent long-term complications like retinopathy, nephropathy and cardiac issues, he added.

“We have technology partners from India, China and the Gulf who stand strongly with us helping us plan volume and growth,” he said, adding the Rs 250 crore Regenix is also rolling out India’s first disposable insulin pen, priced at half the cost of reusable pens, along with smaller 3 ml vials that cut costs and allow room-temperature storage. “This reduces the cumbersome process of loading cartridges in reusable insulin pens, which many patients are not comfortable with,” he said.

Operating out of a special economic zone facility in Tambaram, the plant, built at an investment of Rs 5 million, has an initial capacity of 200 litres, expandable to 1,000 litres. The company, with 1,200 employees, has also created a cold-chain distribution network to ensure quality insulin supply nationwide. It also has a oral solid dosage plant at Alathur which manufactures tablets and capsules. The formulations are exported to South American countries and Philippines.

With the basal insulin market pegged at Rs 2,000 crore, Regenix is targeting a 10 per cent share while working on overseas approvals. Outreach plans include diabetic camps, webinars, and digital campaigns under its India Insulin Initiative. “Our mission is to help diabetics live healthier, longer lives. Diabetes is like fire, easy to control if caught early. Sustaglar is our way of putting that control in patients’ hands,” Dr Ramamurthy said.

A shot of hope for diabetics

· Tamil Nadu’s 1st biosimilar insulin facility; India’s 5th

· Product: Sustaglar, used once-daily, long-acting glargine insulin

· Outcome: 60% less hypoglycemia, stable 24-hr control

· Uniqueness: India’s 1st disposable insulin pen; low-cost 3 ml vials

· Capacity: 200 litres, scaling to 1,000 litres

· Investment: Rs 50 crore over 5 years

· Aiming at 10% of India’s Rs 2,000-cr basal insulin segment

· Network: 104 pharmacies, 35 diagnostic centres

· Workforce: 1,200 employees

· Two-step process: Obese with genetic history can be screened for pre-diabetes through simple blood c-peptide test to detect insulin resistance and prevent development of diabetes. Simple HbA1c test will assess pre-diabetic state and at this stage it can be reversed. These two tests are available even in remote places in India