Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA
12 Julio 2023 - 9:25AM
Business Wire
- In January 2023, the company had announced the successful
completion of the full set of clinical studies of its proposed
rituximab biosimilar candidate DRL_RI, with the intention to file
in the United States, European Union and other regions
- Following dossier submission in April 2023, the regulatory
agencies have now accepted the dossier for review
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.”
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:
- 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 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.
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
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