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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 www.drreddys.co

Key Takeaway: Dr. Reddy's Laboratories announced the successful completion of a Phase I study for its proposed tocilizumab biosimilar, DRL_TC, using an intravenous formulation. The study demonstrated pharmacokinetic equivalence and safety when compared to both the EU and U.S. reference products. Following this achievement, the company plans to initiate a global Phase III study to further compare the biosimilar's efficacy and safety. This milestone is part of Dr. Reddy's ongoing efforts to expand its biosimilars portfolio and enhance patient access to vital medications.

Market Sentiment Analysis

POSITIVE FACTORS

  • Successful completion of Phase I study for DRL_TC biosimilar candidate.
  • Demonstrated pharmacokinetic equivalence and safety compared to reference products.
  • Initiation of a global Phase III study to further evaluate efficacy and safety.
  • Commitment to make high-quality biosimilars accessible and affordable.

Full Press Release Details

Stock Exchange of India Ltd. (Scrip Code: DRREDDY-EQ)
Limited (Scrip Code: 500124)
find enclosed a press release titled "Dr. Reddy's successfully completes Phase I study (IV route) of DRL_TC, a proposed
biosimilar of tocilizumabp."
is for your information.
Dr. Reddy's Laboratories Limited
/s/ K Randhir Singh
K Randhir Singh
Company Secretary, Compliance Officer and Head-CSR
New York Stock Exchange Inc.(Stock Code :RDY)
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
Reddy's successfully completes Phase I study (IV route) of
DRL_TC, a proposed biosimilar of tocilizumab
Tocilizumab is an important anti-rheumatic agent used in the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Phase I study conducted by Dr. Reddy's demonstrated pharmacokinetic equivalence and similarity in pharmacodynamic parameters, safety and immunogenicity between Dr. Reddy's proposed biosimilar candidate (DRL_TC) and European Union (EU) reference medicinal product* and United States (U.S.) reference product** by the intravenous route (IV)
In December 2022, the company had announced the successful completion of the Phase I study of DRL_TC via the subcutaneous route
Global Phase III study is being initiated to compare efficacy, safety, tolerability and immunogenicity of DRL_TC with the reference product
India; June 05, 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 tocilizumab biosimilar candidate,
DRL_TC, successfully met its primary and secondary endpoints in a Phase I study. This Phase I study used an intravenous (IV) formulation
to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy's tocilizumab biosimilar candidate in comparison
to reference products.
Phase I study entitled A Phase I, Double Blind, Randomized, Parallel-group, Single dose, Three arm, Comparative Pharmacokinetic
and Pharmacodynamic Study of Dr. Reddy's Tocilizumab (DRL_TC), USA sourced Reference Tocilizumab (Actemra ) and EU sourced
Reference Tocilizumab (RoActemra ) Administered by the Intravenous Route to Normal Healthy Male Volunteers' met all primary
and secondary endpoints. Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product* and the U.S. reference product**
was successfully demonstrated. The clinical trial also confirmed the similarity between DRL_TC and the EU* and U.S.** reference products
in terms of pharmacodynamic parameters and found no noteworthy differences in safety and immunogenicity across these three treatment
successful outcome of this study represents an important milestone in Dr. Reddy's commitment to make high-quality biosimilar products
more accessible and affordable to healthcare providers and patients around the world. Dr. Reddy's is developing the proposed tocilizumab
biosimilar as both intravenous and subcutaneous formulations.
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
Jayanth Sridhar, Global Head of Biologics at Dr. Reddy's, said: "Tocilizumab is an important anti-rheumatic agent that
has a unique place in treating patients with rheumatoid arthritis and other diseases. By developing the formulation in both subcutaneous
and intravenous formulations, we aim to reach more patients around the world. With our recent milestones in our proposed biosimilars
of tocilizumab and rituximab, our partner's launch of pegfilgrastim in the U.S and Europe, we look forward to maintaining our momentum
as part of our goal to serve over 1.5 billion patients by 2030."
Reddy's has already demonstrated pharmacokinetic equivalence and similarity in pharmacodynamic parameters, safety and immunogenicity
by subcutaneous route. The company is now initiating a global Phase III study with the aim of comparing the efficacy, safety, tolerability
and immunogenicity of DRL_TC with the reference product in patients with moderate to severe active rheumatoid arthritis.
reference medicinal product is RoActemra
reference product is Actemra
and RoActemra are registered trademarks of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
Dr. Reddy's biosimilars programme:
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. In December 2022, we announced
the successful completion of Phase I study and initiation of Phase III study of DRL_TC, our proposed biosimilar of tocilizumab via the
subcutaneous route, for global markets. In January 2023, we announced the successful completion of the full set of clinical studies of
our rituximab biosimilar for filing in the U.S. and Europe. We are also ramping up manufacturing capacity to support our global expansion
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.
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, 2022. The company assumes no obligation to update any information contained herein.

Frequently Asked Questions

What is DRL_TC by Dr. Reddy's?

DRL_TC is a proposed biosimilar of tocilizumab, an anti-rheumatic agent.

What were the results of the Phase I study for DRL_TC?

The Phase I study demonstrated pharmacokinetic equivalence and safety similarity between DRL_TC and its reference products.

What is the next step for DRL_TC?

Dr. Reddy's is initiating a global Phase III study to compare DRL_TC's efficacy and safety.

What are the formulations of DRL_TC being developed?

DRL_TC is being developed in both intravenous and subcutaneous formulations.

What is the aim of Dr. Reddy's biosimilars program?

The biosimilars program aims to provide affordable access to high-quality medicines.

Last updated: Jun 5, 2023