Hyderabad-based Dr. Reddy’s Laboratories has announced the launch of its injectable semaglutide under the brand name Obeda®, marking an important step in expanding access to advanced GLP‑1 receptor agonist–based therapy for the management of type 2 diabetes in India.
Dr. Reddy’s has been the first Indian company to receive Drugs Controller General of India (DCGI) approval for generic semaglutide.
In a head‑to‑head Phase III clinical study enrolling 312 participants, Dr. Reddy’s Obeda® established non‑inferior efficacy and a safety profile comparable to the innovator drug. It showed similar glycaemic reduction. Additionally, comparable results were observed for fasting glucose control, post‑prandial glucose control, and therapeutic glycaemic response (achieving HbA1c <7.0%) at the end of the study. No anti‑drug antibodies were detected, and the immunogenicity profile was similar to that of the innovator drug.
With both API development and manufacturing, as well as formulation development conducted entirely in‑house, Obeda® reflects Dr. Reddy’s strength in complex product development and peptide science. It also showcases the company’s decade‑long expertise in peptide technology and its commitment to bringing GLP‑1 therapies to market to ensure access to high‑quality, affordable medicines and addressing India’s evolving healthcare needs. As part of its future plans for GLP-1 therapies, the company will be looking at a fully integrated API and formulation approach, encompassing both development and manufacturing in-house.
Dr. Reddy’s Obeda® injection is available in 2 mg and 4 mg strengths and comes in a pre‑filled, disposable pen designed for subcutaneous, once‑a-week administration, with robust cold‑chain integrity maintained throughout distribution.
Each pen of both strengths will deliver a minimum of 4 weekly doses. The cost to the patient will be Rs 4,200 per month for both the strengths. Additionally, in a human‑factors study involving 41 participants completing approximately 20 key tasks aligned with the USFDA’s guidance for drug–device combination products, the Obeda® pen demonstrated non‑inferior user‑performance outcomes compared with the innovator pen.
As part of its patient support programme for Obeda®, Dr. Reddy’s has developed SemaKare™, a comprehensive support system to enhance and streamline the patient journey. Supported by a digital app, SemaKare™ offers onboarding guidance, field device‑counsellor assistance, injection training, tele‑support, therapy‑adherence monitoring, and so on, to help improve treatment outcomes for patients.
