Dr. Reddy’s Laboratories secures key European endorsement for Rituximab biosimilar

In a significant development for the pharmaceutical industry, Dr. Reddy’s Laboratories Ltd. has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding its proposed biosimilar, DRL_RI, also known as ITUXREDI. This endorsement could pave the way for the launch of this promising biosimilar across European markets, including the European Union (EU) and the European Economic Area (EEA).

Dr. Reddy’s Laboratories, a global player in the pharmaceutical sector, previously secured the European Union Good Manufacturing Practice (EU GMP) certification for its Rituximab drug substance and product manufacturing facility located in Hyderabad, India. This certification was a crucial step in the approval process for DRL_RI.

Positive CHMP Opinion Marks a Major Milestone

The CHMP’s positive opinion is a major milestone for Dr. Reddy’s, as it progresses towards gaining marketing authorisation from the European Commission. The next steps involve the European Commission’s review of the CHMP opinion, which will determine whether DRL_RI will be granted approval for distribution within EU member states and the EEA. Separately, Dr. Reddy’s will submit a Marketing Authorisation Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the International Recognition Procedure (IRP).

DRL_RI: A Strong Contender in the Biosimilar Market

DRL_RI is being developed as a biosimilar to MabThera, a well-known reference product manufactured by Roche. The proposed biosimilar aims to treat several serious conditions, including Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukaemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangiitis (GPA), Microscopic Polyangiitis (MPA), and Pemphigus Vulgaris (PV). These indications align with those approved for MabThera, making DRL_RI a direct competitor in the biosimilar market.

Dr. Reddy’s Strategic Expansion

Dr. Reddy’s Laboratories views the biosimilars business as a cornerstone of its strategic growth. Over the past 25 years, the company has developed a robust platform for the development, manufacture, and commercialization of biosimilars, particularly in oncology and immunology. The company currently markets a range of biosimilars in India and over 25 other countries, with several products in various stages of development for global markets.

The company is also enhancing its manufacturing capabilities to support its expansion plans. In July 2023, Dr. Reddy’s biosimilar application for Rituximab was accepted for review by the USFDA, EMA, and MHRA. Earlier this year, the company launched Versavo (bevacizumab) in the UK, marking its first biosimilar approval and launch in the country.

Expert Opinion on Dr. Reddy’s Strategic Move

Dr. Reddy’s strategic focus on biosimilars underscores its commitment to expanding its global footprint and addressing unmet medical needs. The successful endorsement of DRL_RI by the CHMP not only reinforces Dr. Reddy’s position in the biosimilars market but also highlights the company’s ability to navigate complex regulatory pathways to bring important treatments to market.

Conclusion

Dr. Reddy’s Laboratories’ recent achievement is a testament to its strategic vision and capability in the biosimilars arena. As the company awaits further regulatory approvals, the positive opinion from the CHMP marks a promising step towards enhancing access to critical therapies across Europe.