Dr. Reddy's Laboratories Awaits Approval for Semaglutide in Canada
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
0mins
Dr. Reddy's Laboratories is still awaiting approval for Semaglutide in Canada, sources with knowledge of the matter told CNBC-TV18's Ekta Batra. Analysts who track Dr. Reddy's expect six to nine months of no competition in the Canadian market, the report noted. Semaglutide is a GLP-1 receptor agonist primarily used for treating Type 2 diabetes and chronic weight management that is sold under brand names Ozempic, Wegovy, and Rybelsus.
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About RDY
Dr. Reddy’s Laboratories Limited is an India-based pharmaceutical company. Its products and services are spread across its core businesses of active pharmaceutical ingredients (APIs), generics, branded generics, biosimilars and over-the-counter (OTC) pharmaceutical products. It works in the areas of gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Its segments consist of Global Generics; Pharmaceutical Services and Active Ingredients (PSAI), and Others. The Global Generics segment consists of the Company's business of manufacturing and marketing prescription and over-the-counter finished pharmaceutical products ready for consumption by the patient, marketed under a brand name (branded formulations) or as generic finished dosages with therapeutic equivalence to branded formulations (generics). The Pharmaceutical Services and Active Ingredients segment consists of the Company's business of manufacturing and marketing APIs and intermediates.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Dr. Reddy's First to Receive Marketing Authorization for Generic Semaglutide Injection in Canada
- Market Authorization Milestone: Dr. Reddy's has received marketing authorization from Health Canada, becoming the first company to obtain approval for generic Semaglutide Injection, covering 2mg/pen and 4mg/pen, which underscores its leadership in the complex generics sector.
- Diabetes Patient Demand: According to the Public Health Agency of Canada, approximately 3.9 million people (9.7% of the population) are diagnosed with diabetes, and as the population ages, the number of diabetes patients is expected to continue rising, providing significant market potential for Dr. Reddy's products.
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- Strategic Market Positioning: Being the first to receive market authorization not only boosts Dr. Reddy's brand influence in Canada but also demonstrates its product development capabilities under stringent global regulatory standards, which is expected to lay a foundation for long-term growth in the diabetes management sector.
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- Interchangeability Goal: Dr. Reddy's aims for DRL_AB to achieve interchangeable status, which, if granted, would allow the drug to be substituted at the pharmacy level without the need for the prescribing healthcare provider's intervention, simplifying the medication process for patients and enhancing market acceptance and competitiveness.
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- Future Market Potential: The biosimilars business at Dr. Reddy's plays a crucial role in driving both near-term and long-term growth, with global expansion plans expected to significantly increase the company's market share in the biologics sector.
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- Strategic Development Focus: Dr. Reddy's aims to expand its product portfolio through the introduction of biosimilars, increasing market share and addressing the growing demand for high-quality biologic therapies, reflecting the company's long-term strategic planning in the biopharmaceutical sector.
See More
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- Biosimilar Application Accepted: Dr. Reddy's 351(k) Biologics License Application (BLA) has been accepted by the US FDA, marking a significant advancement in the biosimilar sector and expected to provide cost-effective treatment options for patients.
- Clinical Research Success: DRL_AB achieved pharmacokinetic similarity with Orencia® in Phase 1 studies, demonstrating comparable safety and immunogenicity, which lays a solid foundation for future clinical applications.
- Significant Market Potential: Upon approval, DRL_AB will be used to treat adults with moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis, and children aged six and above with moderately-to-severely active polyarticular juvenile idiopathic arthritis, significantly enhancing Dr. Reddy's competitiveness in the biopharmaceutical market.
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See More
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Announcement of Acceptance: Dr. Reddy's has announced the acceptance of its application for a review of its biologics license application (BLA) by the US FDA.
Proposed Interchangeable Biosimilar: The review pertains to a proposed interchangeable biosimilar, which is expected to enhance treatment options in the market.
See More
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- Market Authorization Milestone: Dr. Reddy's has received marketing authorization from Health Canada, becoming the first company to obtain approval for generic Semaglutide Injection, covering 2mg/pen and 4mg/pen, which underscores its leadership in the complex generics sector.
- Diabetes Patient Demand: According to the Public Health Agency of Canada, approximately 3.9 million people (9.7% of the population) are diagnosed with diabetes, and as the population ages, the number of diabetes patients is expected to continue rising, providing significant market potential for Dr. Reddy's products.
- In-House Production Capability: Dr. Reddy's active pharmaceutical ingredient (API) is entirely produced in-house, ensuring product quality and supply reliability, while partnering with OneSource Specialty Pharma Limited for finished product manufacturing, further enhancing the company's competitive edge in the market.
- Strategic Market Positioning: Being the first to receive market authorization not only boosts Dr. Reddy's brand influence in Canada but also demonstrates its product development capabilities under stringent global regulatory standards, which is expected to lay a foundation for long-term growth in the diabetes management sector.
See More
Dr. Reddy's Laboratories Seeks FDA Approval for Orencia Biosimilar
- FDA Review Application: Dr. Reddy's Laboratories has received FDA acceptance for its biosimilar DRL_AB, which, if approved, will be available as an intravenous infusion for rheumatoid arthritis and psoriatic arthritis patients, marking a significant advancement in the company's biopharmaceutical endeavors.
- Market Potential: Orencia generated $2.7 billion in revenue for Bristol-Myers Squibb in 2025, reflecting a ~1% year-over-year decline, yet demonstrating robust market demand; Dr. Reddy's biosimilar could directly compete in this lucrative market if approved.
- First Applicant: The company submitted its 351(k) Biologics License Application in December, becoming the first to seek U.S. approval for an off-patent version of Orencia, showcasing its pioneering position in the biosimilar sector.
- Interchangeability Goal: Dr. Reddy's aims for DRL_AB to achieve interchangeable status, which, if granted, would allow the drug to be substituted at the pharmacy level without the need for the prescribing healthcare provider's intervention, simplifying the medication process for patients and enhancing market acceptance and competitiveness.
See More
Dr. Reddy's Submits Biosimilar Application for Review
- Biosimilar Application: Dr. Reddy's Laboratories has had its 351(k) Biologics License Application (BLA) accepted for review by the US FDA, marking a significant milestone in the biosimilar sector and expected to provide cost-effective treatment options for patients.
- Broad Treatment Indications: DRL_AB, as a proposed biosimilar to ORENCIA® (abatacept), targets treatment for moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis, and polyarticular juvenile idiopathic arthritis in patients aged six and above, addressing urgent market needs for effective therapies.
- Comprehensive Data Package: The BLA submission includes a robust data package comprising analytical, pharmacokinetic, and clinical studies, showcasing Dr. Reddy's strong capabilities in biologics development and enhancing its competitive position in the market.
- Future Market Potential: The biosimilars business at Dr. Reddy's plays a crucial role in driving both near-term and long-term growth, with global expansion plans expected to significantly increase the company's market share in the biologics sector.
See More
Dr. Reddy's Submits Biosimilar Application for Abatacept
- BLA Acceptance: The US FDA has accepted Dr. Reddy's 351(k) Biologics License Application for DRL_AB, marking a significant milestone in the biosimilar sector and expected to provide cost-effective treatment options for patients.
- Clinical Study Results: Clinical trials for DRL_AB have demonstrated pharmacokinetic similarity and safety profiles comparable to Orencia®, with Phase 1 successfully achieving these benchmarks, laying the groundwork for ongoing Phase 3 trials.
- Market Potential: Upon approval, DRL_AB will be indicated for moderately-to-severely active rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis, which is anticipated to significantly enhance Dr. Reddy's competitive position in the biopharmaceutical market.
- Strategic Development Focus: Dr. Reddy's aims to expand its product portfolio through the introduction of biosimilars, increasing market share and addressing the growing demand for high-quality biologic therapies, reflecting the company's long-term strategic planning in the biopharmaceutical sector.
See More
Dr. Reddy's Submits Biosimilar Application for Abatacept
- Biosimilar Application Accepted: Dr. Reddy's 351(k) Biologics License Application (BLA) has been accepted by the US FDA, marking a significant advancement in the biosimilar sector and expected to provide cost-effective treatment options for patients.
- Clinical Research Success: DRL_AB achieved pharmacokinetic similarity with Orencia® in Phase 1 studies, demonstrating comparable safety and immunogenicity, which lays a solid foundation for future clinical applications.
- Significant Market Potential: Upon approval, DRL_AB will be used to treat adults with moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis, and children aged six and above with moderately-to-severely active polyarticular juvenile idiopathic arthritis, significantly enhancing Dr. Reddy's competitiveness in the biopharmaceutical market.
- Strategic Development Focus: Dr. Reddy's aims to strengthen its global market presence through the launch of biosimilars like DRL_AB, particularly in the crucial US market, thereby driving long-term growth for the company.
See More
Dr. Reddy's Receives USFDA Approval to Review Biologics License Application for Proposed Interchangeable Biosimilar Abatacept
Announcement of Acceptance: Dr. Reddy's has announced the acceptance of its application for a review of its biologics license application (BLA) by the US FDA.
Proposed Interchangeable Biosimilar: The review pertains to a proposed interchangeable biosimilar, which is expected to enhance treatment options in the market.
See More
