Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe
January 20 2023 - 6:30AM
Business Wire
- Following successful completion of full set of clinical
studies of proposed rituximab biosimilar candidate DRL_RI, Dr.
Reddy’s will now prepare to file in the United States, European
Union and other regions
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 it has successfully
completed 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, Europe and other
regions.
DRL_RI is being developed as a biosimilar of rituximab, a
cluster of differentiation 20 (CD20) directed cytolytic antibody
for approval in the United States, European Union and other regions
for various indications including treatment of adult patients with
rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic
leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and
microscopic polyangiitis.
Dr. Reddy’s rituximab biosimilar has already been approved for
marketing in India and over 25 emerging markets. The company
undertook further clinical development to meet regulatory
requirements of highly regulated markets. With the successful
completion of these clinical studies, Dr. Reddy’s is now preparing
to file Biologics License Application (BLA) / Marketing
Authorisation Application (MAA) dossiers with various regulatory
authorities globally.
Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s,
said: “This is a very important milestone in our biosimilars
journey. The successful completion and positive outcome of these
clinical studies highlights our capability for global clinical
development of biosimilar products for highly regulated and global
markets. These results underscore our commitment to developing high
quality biosimilars and reinforce the potential of DRL_RI as a safe
and effective treatment option to patients across the globe.”
Dr. Reddy’s is currently collaborating with its partner
Fresenius Kabi 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:
- RI-01-003: This study demonstrated pharmacokinetic equivalence
and similarity in pharmacodynamics, safety and immunogenicity
between DRL_RI and EU reference medicinal product* and U.S.
reference product**.
- RI-01-006 (FLINTER): This study demonstrated efficacy
equivalence and similarity in safety and immunogenicity between
DRL_RI and EU reference medicinal product* in patients with Low
Tumour Burden Follicular Lymphoma
- RI-01-007: This study demonstrated similar safety and
immunogenicity profile between the DRL_RI, EU reference medicinal
product* and U.S. reference product** groups upon single transition
from either of them, in subjects with active rheumatoid
arthritis.
*EU reference medicinal product is MabThera® **U.S. reference
product is Rituxan® MabThera® and Rituxan® are registered
trademarks of Roche.
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 future 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 25
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. We recently announced the successful completion
of Phase I study and initiation of Phase III study of DRL_TC, our
proposed biosimilar of tocilizumab, for global markets. 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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the "Risk Factors" and "Forward-Looking Statements" sections of our
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