Dr. Reddy's Submits Biosimilar Application for Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
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Should l Buy RDY?
Source: Businesswire
- 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.
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Analyst Views on RDY
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 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
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 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
Coya Therapeutics Secures $11.1 Million in Private Placement
- Funding Amount: Coya Therapeutics has secured approximately $11.1 million through a private placement of 2,522,727 shares at $4.40 each, reflecting strong market confidence in its biologics development.
- Key Investors: The primary investors include Dr. Reddy’s Laboratories, contributing $10 million, and Greenlight Capital with $1.1 million, indicating a positive outlook from institutional investors regarding Coya's future prospects.
- Use of Proceeds: The company intends to utilize the proceeds to accelerate technology transfer and scale-up manufacturing for low-dose IL-2, supporting the commercial readiness of COYA 302, thereby enhancing its competitive position in the neurodegenerative disease market.
- Compliance Commitment: Coya has committed to filing a registration statement with the SEC within 45 days post-closing, ensuring the legal resale of the securities, which will bolster investor confidence and facilitate future capital operations.
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
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 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
Coya Therapeutics Secures $11.1 Million in Private Placement
- Funding Amount: Coya Therapeutics has secured approximately $11.1 million through a private placement of 2,522,727 shares at $4.40 each, reflecting strong market confidence in its biologics development.
- Key Investors: The primary investors include Dr. Reddy’s Laboratories, contributing $10 million, and Greenlight Capital with $1.1 million, indicating a positive outlook from institutional investors regarding Coya's future prospects.
- Use of Proceeds: The company intends to utilize the proceeds to accelerate technology transfer and scale-up manufacturing for low-dose IL-2, supporting the commercial readiness of COYA 302, thereby enhancing its competitive position in the neurodegenerative disease market.
- Compliance Commitment: Coya has committed to filing a registration statement with the SEC within 45 days post-closing, ensuring the legal resale of the securities, which will bolster investor confidence and facilitate future capital operations.
See More
