NSEPress Release1 Aug 2026 · 1 Aug 2026, 09:43 am
Press Release
Dr. Reddy's Laboratories Limited · DRREDDY
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Dr. Reddy's Laboratories Ltd. has received U.S. FDA approval for its rituximab biosimilar, a biosimilar to Rituxan, 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.
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Full Announcement
Dr. Reddy's Laboratories Limited has informed the Exchange regarding a press release dated August 01, 2026, titled "Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015".
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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
Press Release
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
Te l: + 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.
Press Release
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
Te l: + 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.
Press Release
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
Te l: + 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 govern
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