Dr. Reddy’s Laboratories (NYSE: RDY) secures FDA approval for rituximab biosimilar
Rhea-AI Filing Summary
Dr. Reddy’s Laboratories received U.S. FDA approval for its rituximab biosimilar, a biosimilar to Rituxan (rituximab), for the U.S. market. The product was developed, manufactured and submitted by Dr. Reddy’s, and the approval followed a successful Pre-License Inspection at its biologics facility in Bachupally, Hyderabad.
Under an exclusive commercialization agreement, Fresenius Kabi will market the product in the United States, a key global pharmaceutical market. The rituximab biosimilar is already commercialized in India, the European Union, the United Kingdom and more than 25 emerging markets, with additional approvals in Switzerland and Canada, reinforcing Dr. Reddy’s strategy to expand its biosimilars portfolio in oncology and autoimmune diseases.
Positive
- U.S. FDA approval of Dr. Reddy’s rituximab biosimilar opens the U.S. market for a key oncology and autoimmune therapy under an exclusive commercialization deal with Fresenius Kabi.
Negative
- None.
Key Figures
Key Terms
biosimilar medical
Pre-License Inspection (PLI) regulatory
monoclonal antibody medical
B-cell malignancies medical
granulomatosis with polyangiitis (GPA) medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did Dr. Reddy’s Laboratories (RDY) announce about its rituximab biosimilar?
Who will commercialize Dr. Reddy’s (RDY) rituximab biosimilar in the United States?
In which markets is Dr. Reddy’s (RDY) rituximab biosimilar already available?
What evidence supported FDA approval of Dr. Reddy’s (RDY) rituximab biosimilar?
For which diseases is rituximab used, according to Dr. Reddy’s (RDY) disclosure?
How important is the biosimilars business to Dr. Reddy’s (RDY) strategy?
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13A-16 OR 15D-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
August, 2026
Commission File Number 1-15182
DR. REDDY’S LABORATORIES LIMITED
(Translation of registrant’s name into English)
8-2-337, Road No. 3, Banjara Hills
Hyderabad, Telangana 500 034, India
+91-40-49002900
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ______
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If “Yes” is marked, indicate below the file number assigned to registrant in connection with Rule 12g3-2(b): 82-________.
EXHIBITS
Exhibit Number |
| Description of Exhibits |
|
|
|
99.1 | Intimation dated August 1, 2026 |
| 2 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| DR. REDDY’S LABORATORIES LIMITED (Registrant) | ||
|
|
|
|
Date: August 1, 2026 | By: | /s/ K Randhir Singh | |
|
| Name: | K Randhir Singh |
|
| Title: | Company Secretary |
| 3 |
Exhibit 99.1
| Dr. Reddy's Laboratories Ltd. 8-2-337, Road No. 3, Banjara Hills Hyderabad – 500 034, Telangana, India
CIN: L85195TG1984PLC004507
Tel: + 91 40 4900 2900 Fax: + 91 40 4900 2999 Email: mail@drreddys.com Web: www.drreddys.com |
August 1, 2026
National Stock Exchange of India Ltd. (Scrip Code: DRREDDY)
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Dear Sir/Madam,
Ref: | Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 |
Please find enclosed a Press Release viz. “Dr. Reddy's Laboratories Receives U.S. FDA Approval for Rituximab Biosimilar”
This is for your information and records.
Thanking you,
Yours faithfully,
For Dr. Reddy’s Laboratories Limited
K Randhir Singh
Company Secretary, Compliance Officer & Head-CSR
Dr. Reddy's Laboratories Ltd. | CONTACT | |
8-2-337, Road No. 3, Banjara Hills |
|
|
Hyderabad – 500 034, Telangana, India | Investor relationS | Media relationS |
|
|
|
CIN: L85195TG1984PLC004507 |
|
|
|
|
|
Tel: + 91 40 4900 2900 | Aishwarya Sitharam | SANTOSH VYAS |
Fax: + 91 40 4900 2999 | aishwaryasitharam@drreddys.com | SANTOSH.VYAS@DRREDDYS.COM |
Email: mail@drreddys.com |
|
|
Web: www.drreddys.com |
|
|
Dr. Reddy's Laboratories Receives U.S. FDA
Approval for Rituximab Biosimilar
Dr. Reddy’s growing global biosimilars portfolio
Fresenius Kabi to exclusively commercialize the product in the United States
Hyderabad, India, August 1, 2026 – Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) today announced that the U.S. Food and Drug Administration (FDA) has approved its rituximab biosimilar, a biosimilar to Rituxan® (rituximab), for the U.S. market.
The approval further strengthens Dr. Reddy's growing global biosimilars portfolio and advances its biosimilars business in the United States.
The product was developed, manufactured and submitted for approval by Dr. Reddy's Laboratories. The approval follows the successful recent Pre-License Inspection (PLI) conducted by the U.S. FDA at the Company's biologics manufacturing facility in Bachupally, Hyderabad, and reflects the company's capabilities in bringing complex biologic medicines to highly regulated markets and its long-standing commitment to biosimilars.
Under a commercialization agreement, Fresenius Kabi holds the exclusive rights to commercialize the product in the United States, one of the world's most important pharmaceutical markets.
"The approval of the rituximab biosimilar on the FDA’s goal date reflects our capabilities in developing and manufacturing complex biologic medicines for global markets," said Sridevi Khambhampaty, Global Head, Biologics, Dr. Reddy's Laboratories.
The rituximab biosimilar has been commercialized in India, the European Union, the United Kingdom and more than 25 emerging markets, and has also received marketing approval in Switzerland and Canada.
Dr. Reddy's Laboratories Ltd. | CONTACT | |
8-2-337, Road No. 3, Banjara Hills |
|
|
Hyderabad – 500 034, Telangana, India | Investor relationS | Media relationS |
|
|
|
CIN: L85195TG1984PLC004507 |
|
|
|
|
|
Tel: + 91 40 4900 2900 | Aishwarya Sitharam | SANTOSH VYAS |
Fax: + 91 40 4900 2999 | aishwaryasitharam@drreddys.com | SANTOSH.VYAS@DRREDDYS.COM |
Email: mail@drreddys.com |
|
|
Web: www.drreddys.com |
|
|
Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes and is widely used in the treatment of several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as certain autoimmune conditions.
The FDA approval is supported by a comprehensive body of analytical, non-clinical and clinical evidence demonstrating that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity and potency, consistent with FDA requirements for biosimilar approval.
About Rituximab
Rituximab is a monoclonal antibody that selectively targets the CD20 protein expressed on B-cells. By binding to CD20, rituximab induces B-cell depletion through multiple immune-mediated mechanisms.
In the United States, rituximab is approved for the treatment of adults with several hematologic malignancies and autoimmune diseases, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait,’ we offer a portfolio of products and services including
APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance.
Over the last 25 years, our Biologics team has developed into a fully integrated organization with robust capabilities in the development, manufacture and commercialization of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India, with some products marketed in more than 30 other countries. In addition, we have several products in the pipeline in oncology and autoimmune diseases in various stages of development for global launches across developed as well as emerging markets. We are also ramping up manufacturing capacity to support our global expansion plans. In 2024, we launched our first biosimilar in the United Kingdom, Versavo® (biosimilar bevacizumab). This follows our launch of pegfilgrastim in the U.S. and Europe through our partner. We also launched our rituximab biosimilar in Europe in 2025. Our biosimilars business has a key role to play in driving both near-term and long-term growth.
For more information, log on to: www.drreddys.com.
Dr. Reddy's Laboratories Ltd. | CONTACT | |
8-2-337, Road No. 3, Banjara Hills |
|
|
Hyderabad – 500 034, Telangana, India | Investor relationS | Media relationS |
|
|
|
CIN: L85195TG1984PLC004507 |
|
|
|
|
|
Tel: + 91 40 4900 2900 | Aishwarya Sitharam | SANTOSH VYAS |
Fax: + 91 40 4900 2999 | aishwaryasitharam@drreddys.com | SANTOSH.VYAS@DRREDDYS.COM |
Email: mail@drreddys.com |
|
|
Web: www.drreddys.com |
|
|
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2026. The company assumes no obligation to update any information contained herein.