Dr. Reddy’s Receives Positive CHMP Opinion From European Medicines Agency for Its Proposed Rituximab Biosimilar

Rhea-AI Summary

Dr. Reddy's Laboratories (NYSE: RDY) has received a positive opinion from the European Medicines Agency's CHMP for its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI®). This recommendation paves the way for potential marketing authorization in EU and EEA member states. The biosimilar is being developed as an alternative to MabThera® (Rituximab), with intended indications including Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukaemia, Rheumatoid Arthritis, and other conditions.

This development is part of Dr. Reddy's strategic biosimilars program, which has been a key focus for the company over the past 25 years. The company has already launched biosimilar products in India and over 25 other countries, with plans for global expansion in regulated and emerging markets.

Positive

• Positive CHMP opinion for Rituximab biosimilar, potentially leading to EU market authorization
• Expansion of biosimilar portfolio in oncology and immunology
• Potential entry into European market, enhancing global presence
• Progress in strategic biosimilars program, driving near-term and long-term growth

Negative

• None.

Pharmaceutical Industry Analyst

The positive CHMP opinion for Dr. Reddy's proposed rituximab biosimilar, DRL_RI (ITUXREDI®), marks a significant milestone in the company's biosimilars program. This development has several important implications:

• Market Expansion: A potential approval by the European Commission would open up a substantial market opportunity for Dr. Reddy's in the EU and EEA countries. The rituximab market in Europe is worth billions of euros annually.
• Revenue Growth: Successful launch in European markets could drive significant revenue growth for Dr. Reddy's, as biosimilars typically capture a considerable market share due to their lower pricing compared to the originator drug.
• Competitive Positioning: This advancement strengthens Dr. Reddy's position in the global biosimilars market, particularly in oncology and immunology therapeutic areas.
• Manufacturing Capabilities: The EU GMP certificate for the Hyderabad facility demonstrates Dr. Reddy's robust manufacturing capabilities, which is important for biosimilar production and could lead to more opportunities in contract manufacturing.

However, investors should note that final approval is still pending and the company will face competition from other rituximab biosimilars already in the market. The success will largely depend on Dr. Reddy's pricing strategy and ability to gain market share rapidly.

Oncology Specialist

The potential introduction of Dr. Reddy's rituximab biosimilar in European markets is a positive development for cancer treatment. Rituximab is a critical drug in the treatment of various B-cell malignancies and autoimmune disorders. Here's why this matters:

• Increased Access: Biosimilars typically lead to reduced treatment costs, potentially increasing access to this important therapy for more patients across Europe.
• Treatment Options: The availability of another rituximab biosimilar provides more options for healthcare providers, potentially leading to improved patient care and treatment customization.
• Clinical Equivalence: The positive CHMP opinion suggests that DRL_RI has demonstrated comparable efficacy, safety and quality to the reference product MabThera®.
• Broad Indications: The proposed indications cover a wide range of conditions, including Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia and several autoimmune diseases, reflecting the versatility of rituximab in clinical practice.

From a clinical perspective, the introduction of this biosimilar could lead to more widespread use of rituximab-based therapies, potentially improving outcomes for patients with these conditions. However, real-world data will be important to confirm its long-term efficacy and safety profile compared to the originator and other biosimilars.

Biotech Investment Analyst

Dr. Reddy's progress with its rituximab biosimilar is a strong indicator of the company's growing capabilities in the high-value biosimilars market. Here's what investors should consider:

• Pipeline Strength: This development showcases the robustness of Dr. Reddy's biosimilar pipeline. With applications for rituximab also under review in the US and UK, the company is positioning itself for multi-market growth.
• Revenue Diversification: Success in biosimilars could help Dr. Reddy's diversify its revenue streams, reducing dependence on traditional generic drugs which face intense price competition.
• Long-term Growth Driver: The biosimilars business is identified as a key strategic initiative for both near-term and long-term growth, indicating management's commitment to this area.
• Global Expansion: The company's plans for global launches across regulated and emerging markets suggest a well-thought-out expansion strategy.
• Manufacturing Investment: The mention of ramping up manufacturing capacity indicates significant capital investment, which could pay off with increased market share but also carries execution risks.

While the news is positive, investors should also consider the competitive landscape in the biosimilars market, potential pricing pressures and the need for substantial ongoing R&D investment. The success of Versavo® (bevacizumab) in the UK provides some confidence, but each biosimilar launch will face its own challenges in market penetration and adoption.

HYDERABAD, India--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI^®) in European markets.

Dr. Reddy’s had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad, India. As part of the established approval process, the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorisation in the European Union (EU) member countries, and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. A Marketing Authorisation Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure (IRP).

DRL_RI is being developed as a biosimilar of MabThera^® (Rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. ITUXREDI^® / DRL_RI (rituximab) is a proposed biosimilar to reference medicinal product MabThera^® and the intended indications are the same as those currently approved for MabThera®: Non–Hodgkin’s Lymphoma (NHL); Chronic Lymphocytic Leukaemia (CLL); Rheumatoid Arthritis (RA); Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA); Pemphigus Vulgaris (PV).

EMA reference product, MabThera®, is a registered trademark 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 25 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 portfolio of commercial products in India, with some products marketed in more than 25 other countries. 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 are also ramping up manufacturing capacity to support our global expansion plans. In July 2023, our proposed rituximab biosimilar application was accepted for review by the USFDA, EMA and MHRA. Earlier this year, we launched Versavo® (bevacizumab) in the UK, making it our first biosimilar product to be approved and launched in that country.

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, 2024. The company assumes no obligation to update any information contained herein.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240729173282/en/

INVESTOR RELATIONS

RICHA PERIWAL

richaperiwal@drreddys.com

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy’s Laboratories Ltd.

FAQ

What is the significance of CHMP's positive opinion for Dr. Reddy's (RDY) Rituximab biosimilar?

The positive opinion from CHMP is a important step towards obtaining marketing authorization for Dr. Reddy's Rituximab biosimilar in European Union and EEA member states, potentially expanding the company's market presence and revenue streams.

What are the intended indications for Dr. Reddy's (RDY) Rituximab biosimilar ITUXREDI®?

ITUXREDI® is intended for treating Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukaemia, Rheumatoid Arthritis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, and Pemphigus Vulgaris, mirroring the indications of the reference product MabThera®.

How does the Rituximab biosimilar fit into Dr. Reddy's (RDY) overall business strategy?

The Rituximab biosimilar is part of Dr. Reddy's key strategic biosimilars program, which aims to drive both near-term and long-term growth for the company by expanding its portfolio in oncology and immunology across global markets.

What is the current status of Dr. Reddy's (RDY) biosimilars program as of 2023?

As of 2023, Dr. Reddy's has commercial biosimilar products in India and over 25 other countries, with several products in the pipeline. The company's Rituximab biosimilar application has been accepted for review by USFDA, EMA, and MHRA, and they have launched Versavo® (bevacizumab) in the UK.