Dr Reddy’s launches oral semaglutide biosimilar Obeda for type 2 diabetes in India

Drugmaker Dr Reddy’s Laboratories Ltd on Wednesday (May 20) announced the launch of its oral semaglutide biosimilar in India under the brand name Obeda, indicated for the treatment of type 2 diabetes mellitus.

The company said the formulation is based on recombinant DNA (rDNA) origin semaglutide active pharmaceutical ingredient (API). Obeda is available in tablet form and is administered as a once-daily oral therapy.

The launch follows Dr Reddy’s recent generic semaglutide injection introductions in India and Canada, strengthening its presence in GLP-1 therapies.

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The approval for oral semaglutide was granted by the Central Drugs Standard Control Organisation (CDSCO) after reviewing a Phase III clinical study conducted in India. The study enrolled 288 participants with type 2 diabetes mellitus. The company stated that the study demonstrated non-inferior efficacy and a safety profile comparable to the innovator oral drug.

Results included similar outcomes in fasting plasma glucose, post-prandial plasma glucose, weight loss and overall glycemic control, measured by the proportion of participants achieving HbA1c below 7% at 12 and 24 weeks.

No anti-drug antibodies were detected in the study, and the immunogenicity profile was reported to be comparable to the innovator drug. Obeda is available in 3 mg, 7 mg and 14 mg strengths. It is recommended for once-daily oral use. The price has been set at ₹99 for 3 mg, ₹135 for 7 mg and ₹225 for 14 mg tablets.

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As per the ICMR INDIAB study, India represents one of the world’s largest diabetes burdens, with over 101 million adults living with the condition and a prevalence of 11.4%. Alarmingly, nearly 136 million individuals are prediabetic, and close to 40% of adults have abdominal obesity, placing them at high risk of progression.

Despite multiple treatment options, uncontrolled type 2 diabetes remains a significant challenge. Oral semaglutide, a Glucagon-Like Peptide-1 receptor agonist (GLP-1 RA), is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

M V Ramana, Chief Executive Officer, Global Generics, Dr Reddy’s, said, "The launch of our oral semaglutide for patients with diabetes marks an important step in our journey to broaden access to advanced diabetes care. We recognise that every patient’s journey with diabetes is different, and treatment choices must reflect that diversity. With this launch, we are broadening our GLP 1 portfolio to offer patients more choice and flexibility.

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As the product is developed and formulated in-house, we are committed to reliable supply and consistent quality for patients in India. As we continue to build a comprehensive GLP‑1 portfolio, we are focused on delivering innovation, high-quality, and affordability, translating into meaningful treatment options and better long-term outcomes for people living with chronic metabolic diseases in India and beyond."

Shares of Dr Reddy's Laboratories Ltd ended at ₹1,320.00, down by ₹13.95, or 1.05%, on the BSE.