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biotech/news//Business Standard
The once-daily prescription tablet for type 2 diabetes received CDSCO approval after a Phase III trial showed comparable efficacy and safety to the innovator oral drug.
Dr. Reddy’s launched Obeda, an oral semaglutide biosimilar tablet, in India.
KEY POINTS
Obeda’s Phase III Indian trial showed non-inferior efficacy and comparable safety to the innovator drug.
No anti-drug antibodies were detected in the trial, matching the reference product’s immunogenicity profile.
Obeda uses an rDNA-origin API developed and manufactured entirely in-house by Dr. Reddy’s.
Obeda is available in three dosage strengths, with the lowest priced at Rs 99 per tablet.
The once-daily prescription tablet for type 2 diabetes received CDSCO approval after a Phase III trial showed comparable efficacy and safety to the innovator drug
Anjali Singh Mumbai
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Dr. Reddy’s Laboratories has announced the commercial launch of its oral semaglutide biosimilar under the brand name Obeda in India. The once-daily prescription tablet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults living with type 2 diabetes mellitus.
The launch follows the company’s recent introduction of generic semaglutide injections in India and Canada, expanding its portfolio of glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapies.
According to data cited from the ICMR-INDIAB study, India faces a significant metabolic disease burden, with more than 101 million adults diagnosed with diabetes, an 11.4 per cent prevalence rate, and approximately 136 million individuals classified as prediabetic.
The Central Drugs Standard Control Organisation (CDSCO) granted marketing approval for Obeda following a review of data from a Phase III clinical study conducted in India. The trial enrolled 288 participants with type 2 diabetes.
According to the company’s regulatory filing, the clinical study demonstrated non-inferior efficacy and a comparable safety profile to the innovator oral drug. The trial measured parameters including fasting and post-prandial plasma glucose, weight reduction, and the proportion of participants achieving an HbA1c level below 7 per cent at 12 and 24 weeks. Additionally, the study reported that no anti-drug antibodies were detected, indicating an immunogenicity profile comparable to the reference product.
Obeda is formulated using a recombinant DNA (rDNA)-origin active pharmaceutical ingredient (API), developed and manufactured in-house by Dr. Reddy’s. The medication is available in three distinct strengths to allow flexible dosing, with pricing structured by dosage. The lowest strength, 3 mg, is priced at Rs 99 per tablet. The mid-range 7 mg dose is available at Rs 135 per tablet, while the highest strength of 14 mg is priced at Rs 225 per tablet.
“The launch of our oral semaglutide for patients with diabetes marks an important step in our journey to broaden access to advanced diabetes care,” said M V Ramana, chief executive officer, Global Generics, at Dr. Reddy’s. “As the product is developed and formulated in-house, we are committed to reliable supply and consistent quality for patients in India.”
The company stated that the in-house manufacturing structure is designed to secure supply-chain reliability for the chronic metabolic disease market in India and potentially other emerging regions. As a prescription-only medication, patients are advised to consult medical professionals regarding treatment regimens.
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First Published: May 20 2026 | 6:48 PM IST