Buy Dr Reddys Laboratories Ltd For Target Rs 1,522 By JM Financial Services
Dr. Reddy’s Laboratories participated in the JM Investor Conference, represented by M. V. Narasimham, Chief Financial Officer, and Ms. Aishwarya Sitharam from the Investor Relations team. Key updates included the receipt of DGCI approval for semaglutide in India and the submission of Dr. Reddy’s response to the Canadian authority regarding the CRL dated 28th October. A complete summary of the main developments is provided below.
* GLP-1 – Canada Response Submitted: Dr. Reddy’s has submitted its response for generic semaglutide approval in Canada, which is expected to be the first major market to open. Although approval timelines typically range from 45 days to 5 months (and occasionally up to ~200 days), management expects approval before May or June because the company is a first filer. The Canadian GLP-1 market is dominated by autoinjectors, with no meaningful vial opportunity, and prices generally fall more than 50% once two players enter and over 75% with three or more. Dr. Reddy’s believes it retains a competitive advantage because later filers are scheduled for subsequent interactions with Health Canada.
* GLP-1 – DGCI Approval Received in India: In India, Dr. Reddy’s has obtained the API license and secured both SEC and DGCI approval for semaglutide, while other manufacturers with SEC approval have yet to receive DGCI clearance. Patent litigation with Novo Nordisk permits manufacturing but restricts launch until March 2026, when the patent expires. Dr. Reddy’s will follow the court’s direction and will delay commercial launch until that date. The company is also developing oral semaglutide and will leverage its established diabetes-focused field force to build a strong long-term GLP-1 presence in India.
* GLP-1 – Brazil and Other Emerging Markets: Brazil follows an independent regulatory pathway, and Dr. Reddy’s expects semaglutide approval in CY26 for a market valued at roughly USD 800 mn and dominated by local players. The company is also securing COPP certifications for Turkey, South Africa, and additional emerging markets to expand global access. From 2H FY27, semaglutide manufacturing will shift to Dr. Reddy’s internal facilities, while autoinjector devices will continue to be sourced from a third party. Fill–finish operations will be handled by Stelis once the facility receives regulatory approval.
* Denosumab: Denosumab has completed regulatory review in both the U.S. and EU, with an EU launch expected next quarter and the U.S. launch pending goal-date confirmation. While its financial contribution will be modest, denosumab plays an important strategic role by establishing stronger U.S. and EU commercial infrastructure ahead of the company’s larger biosimilar opportunities.
* Abatacept: Abatacept remains one of Dr. Reddy’s most significant biosimilar programs. The IV formulation is planned for U.S. filing in December 2025 with anticipated approval by end-CY26, and EU filing and approval are expected around mid-CY26. The SC formulation will be filed in the EU with an estimated 12-month review timeline, while the U.S. SC launch must wait until exclusivity expiry in February 2028. Dr. Reddy’s expects to achieve interchangeability, supported by completed bridge studies. The U.S. abatacept market exceeds USD 2 bn, with a 50/50 commercial split, while Europe follows a 70/30 structure. Notably, no competitors are known to be pursuing SC abatacept filing in Europe, making this a high-value opportunity.
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