Dr. Reddy’s Successfully Completes Phase I Study (IV Route) of DRL_TC, a Proposed Biosimilar of Tocilizumab
05 Junio 2023 - 6:00AM
Business Wire
- 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
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.
The 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 groups.
The 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.
Dr. 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.”
Dr 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.
*EU reference medicinal product is RoActemra®
**U.S. reference product is Actemra®
Actemra® and RoActemra® are registered trademarks of Chugai
Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
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. 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
plans.
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.
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INVESTOR RELATIONS RICHA PERIWAL richaperiwal@drreddys.com
MEDIA RELATIONS USHA IYER USHAIYER@DRREDDYS.COM
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