Recent Updates
Recently added Catalysts
RDY

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 www.drreddys.co

Key Takeaway: National Stock Exchange of India Ltd. (Scrip Code: DRREDDY-EQ) BSE Limited (Scrip Code: 500124) New York Stock Exchange Inc.(Stock Code: RDY) Please find enclosed a press release titled "Dr. Reddy's proposed rituximab biosimilar application accepted for review by USFDA, EMA a

Full Press Release Details

National Stock Exchange of India Ltd. (Scrip Code: DRREDDY-EQ)
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc.(Stock Code: RDY)
Please find enclosed a press release titled "Dr.
Reddy's proposed rituximab biosimilar application accepted for review by USFDA, EMA and MHRA."
This is for your information.
For Dr. Reddy's Laboratories Limited
/s/ K Randhir Singh
K Randhir Singh
Company Secretary, Compliance Officer and Head-CSR
CONTACT
DR. REDDY'S LABORATORIES LTD. Investor relationS Media relationS
8-2-337, Road No. 3, Banjara Hills, RICHA PERIWAL USHA IYER
Hyderabad - 500034. Telangana, India. RICHAPERIWAL@DRREDDYS.COM ushaiyer@drreddys.com
Dr. Reddy's proposed rituximab biosimilar
application accepted for review by USFDA, EMA and MHRA
Hyderabad, India; July 12, 2023 - Dr.
Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as "Dr. Reddy's"),
a global pharmaceutical company, announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate
DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA). This closely follows acceptance of
its rituximab biosimilar dossier for review by two other regulatory agencies - the European Medicines Agency (EMA) and the United
Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA).
In January 2023, Dr. Reddy's had
announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI,
for filing in highly regulated markets such as the United States, European Union, and other regions. The submission of its dossier
in April 2023 was based on a comprehensive data package including robust structural and functional analytical comparison data using
multiple orthogonal techniques, pre-clinical, and head-to-head clinical studies that demonstrate similarity in pharmacokinetics,
pharmacodynamics, safety, efficacy and immunogenicity with the EU* and U.S.** reference products.
DRL_RI is being developed as a biosimilar of Rituxan
/ MabThera (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. Rituxan / MabThera is approved
for various indications including for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic
leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Dr. Jayanth Sridhar, Global Head of Biologics at
Dr. Reddy's, said: "This milestone underscores our capability for global clinical development of high-quality biosimilar
products for highly regulated and global markets. It also reinforces the potential of DRL_RI as a safe and effective treatment option
for patients across the globe. Development and commercialisation of biological drugs is an important growth lever for our business. We
expect to bring many more biosimilar and other critical biological products to meet patient needs as we work towards our goal of serving
over 1.5 billion patients by 2030."
CONTACT
DR. REDDY'S LABORATORIES LTD. Investor relationS Media relationS
8-2-337, Road No. 3, Banjara Hills, RICHA PERIWAL USHA IYER
Hyderabad - 500034. Telangana, India. RICHAPERIWAL@DRREDDYS.COM ushaiyer@drreddys.com
Dr. Reddy's rituximab biosimilar has already
been approved for marketing in India and over 25 emerging markets. The company is currently collaborating with its partner Fresenius Kabi,
a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs
for critical and chronic conditions, to commercialise its proposed biosimilar of rituximab in the United States. The company intends to
commercialise the product in Europe and other geographies directly.
About Dr. Reddy's clinical studies for its
proposed biosimilar of rituximab, DRL_RI:
*EU reference medicinal product is MabThera
**U.S. reference product is Rituxan
MabThera and Rituxan are registered trademarks
About Dr. Reddy's biosimilars programme:
Dr. Reddy's biosimilars business is part of
our key strategic initiatives expected to drive both near-term and long-term growth. Over the last 20 years, our Biologics team has developed
into a fully integrated organisation with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar
products in oncology and immunology. We have a current portfolio of six commercial products marketed in India and over 27 Emerging Markets.
In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global
launches across regulated as well as emerging markets. Recently, we announced the successful completion of Phase I study and initiation
of Phase III study of DRL_TC, our proposed biosimilar of tocilizumab via both the subcutaneous and intravenous routes, for global markets.
We are also ramping up manufacturing capacity to support our global expansion plans.
CONTACT
DR. REDDY'S LABORATORIES LTD. Investor relationS Media relationS
8-2-337, Road No. 3, Banjara Hills, RICHA PERIWAL USHA IYER
Hyderabad - 500034. Telangana, India. RICHAPERIWAL@DRREDDYS.COM ushaiyer@drreddys.com
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. For more information, log on to: 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, 2023. The company assumes no obligation to update any information
Last updated: Jul 12, 2023