Dr. Reddy's Brings Oral Semaglutide Biosimilar Obeda® to Indian Market

Dr. Reddy's Laboratories Ltd., the multinational pharmaceutical firm, has introduced Obeda®, its oral semaglutide biosimilar designed to treat type 2 diabetes mellitus in India. The tablet formulation represents an expansion of the company's GLP-1 therapy offerings, building on its recent launches of generic semaglutide injections across India and Canada.

India faces a significant diabetes challenge, according to the ICMR INDIAB study. More than 101 million adults in the country currently live with diabetes, representing a prevalence rate of 11.4%. The situation is compounded by the fact that approximately 136 million individuals are classified as prediabetic, while nearly 40% of the adult population contends with abdominal obesity, a risk factor for disease progression.

Semaglutide functions as a Glucagon-Like Peptide-1 receptor agonist (GLP-1 RA), working alongside dietary modifications and physical activity to enhance blood sugar management in adults with type 2 diabetes. The medication offers a convenient and adaptable treatment approach that may enable earlier intervention, boost patient compliance, and potentially mitigate the development of long-term complications.

The formulation uses recombinant DNA-derived semaglutide as its active pharmaceutical ingredient. Dr. Reddy's received regulatory clearance from the CDSCO based on a Phase III trial involving 288 Indian participants with type 2 diabetes. The study demonstrated that the biosimilar achieved comparable effectiveness to the reference medication, with equivalent safety outcomes.

Trial participants showed similar improvements in fasting glucose levels, glucose readings after meals, and weight reduction. The proportion of patients reaching an HbA1c level below 7% at both the 12-week and 24-week marks matched the innovator drug's performance. Notably, the study detected no anti-drug antibodies, and the immune response profile aligned with that of the reference product.

Obeda® comes in three tablet strengths: 3 mg, 7 mg, and 14 mg, each intended for once-daily administration. The pricing structure sets the 3 mg tablets at Rs. 99 each, 7 mg tablets at Rs. 135, and 14 mg tablets at Rs. 225 per unit.

M.V. Ramana, Chief Executive Officer of Global Generics at Dr. Reddy's, commented on the significance of the launch: "This represents a meaningful advancement in expanding patient access to modern diabetes management. We understand that diabetes affects individuals differently, and treatment approaches should reflect this reality. Through this launch, we are enhancing our GLP-1 options to provide patients with greater autonomy and adaptability in their care. Since we develop and manufacture this product in-house, we stand behind its dependable supply and quality standards. As we continue strengthening our GLP-1 offerings, our commitment remains centered on delivering cutting-edge solutions that combine quality with affordability, ultimately providing Indian patients and those globally with better therapeutic alternatives and enhanced outcomes for chronic metabolic conditions."

The medication is available only through prescription. Individuals interested in using Obeda® should consult with their healthcare provider for guidance on suitability and usage.