Dr. Reddy’s Launches India’s First DCGI-Approved Semaglutide
Filing Summary
Dr. Reddy’s Laboratories Ltd. has announced the launch of India’s first DCGI-approved semaglutide injection, branded as Obeda®, for Type 2 Diabetes. This marks the company’s entry into the GLP-1 receptor agonists therapy segment. Obeda® is available in 2 mg and 4 mg strengths, with a monthly cost of INR 4,200. The product is developed and manufactured in-house, reflecting Dr. Reddy’s capabilities in peptide science. The launch aligns with the company’s strategy to expand its diabetes treatment portfolio and improve access to advanced therapies in India.
Dr. Reddy’s Laboratories Ltd. has launched India’s first DCGI-approved semaglutide injection under the brand name Obeda®. This development marks the company’s entry into the GLP-1 receptor agonists therapy segment for Type 2 Diabetes. The product is available in 2 mg and 4 mg strengths and is designed for subcutaneous, once-a-week administration using a pre-filled, disposable pen. The monthly cost for patients is INR 4,200 for both strengths.
The semaglutide injection, Obeda®, was developed and manufactured entirely in-house by Dr. Reddy’s, showcasing the company’s expertise in complex product development and peptide science. The product’s development included a head-to-head Phase III clinical study with 312 participants, demonstrating non-inferior efficacy and a safety profile comparable to the innovator drug. The study reported similar glycaemic reduction and no detection of anti-drug antibodies.
Dr. Reddy’s has structured the launch of Obeda® to coincide with the patent expiry of the innovator drug, ensuring a Day-1 entry into the market. The company plans to introduce generic semaglutide in several countries as part of its phase-1 launch, pending regulatory approvals. This strategic move is part of Dr. Reddy’s broader initiative to build a comprehensive GLP-1 portfolio for multiple metabolic disorders.
The launch of Obeda® is significant in the context of India’s diabetes burden, with over 101 million adults affected, as per the ICMR-INDIAB study. The study highlights a diabetes prevalence of 11.4% and a high risk of disease development among pre-diabetic individuals. Semaglutide, a GLP-1 receptor agonist, has a proven track record globally for improving glycaemic control and supporting weight management.
Dr. Reddy’s Laboratories, a global pharmaceutical company, is focused on providing access to affordable and innovative medicines. The company offers a portfolio that includes APIs, generics, branded generics, biosimilars, and OTC products. Its major therapeutic areas include gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology. Dr. Reddy’s operates in major markets such as the USA, India, Russia & CIS countries, China, Brazil, and Europe.