Dr Reddy’s Gets Positive EMA Opinion for Rituximab Biosimilar

Dr Reddy’s Laboratories, along with its subsidiary, announced on Monday, June 29, that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate in European markets.

Key Takeaways from Dr Reddy’s Drug Approval

• Dr Reddy’s Laboratories receives a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its proposed Rituximab biosimilar.
• The approval paves the way for marketing authorisation in the EU and EEA countries, pending a final decision by the European Commission. 
• A separate Marketing Authorisation Application (MAA) will be submitted to the UK’s MHRA under the International Recognition Procedure.
  
   

The positive CHMP opinion is a key step toward marketing authorisation in the EU, with the European Commission's final decision pending. The approval covers the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. 

Dr Reddy’s Rituximab manufacturing facility in Hyderabad, India, has already received the EU GMP certificate, underscoring the company's readiness to launch the biosimilar in the European market.

In addition to the EU approval process, Dr Reddy’s plans include submitting a Marketing Authorisation Application (MAA) to the UK’s Medicines and Healthcare Products Regulatory Agency under the International Recognition Procedure. 

‘This positive opinion represents a significant milestone for Dr Reddy’s as it continues to expand its biosimilar portfolio, offering new treatment options for autoimmune diseases like Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)’, the company said via exchanges on Monday.

About Dr Reddy’s Laboratories Limited

Dr Reddy's Laboratories Limited is a multinational pharmaceutical firm headquartered in India that was founded in 1984. The firm provides a wide range of products and services, including active pharmaceutical ingredients (APIs), generics, branded generics, biosimilars, and over-the-counter (OTC). Its primary clinical areas of interest are gastrointestinal, cardiovascular, diabetology, cancer, pain management, and dermatology. 

Reddy's business segments include Pharmaceutical Services and Active Ingredients, Global Generics, and others. The Pharmaceutical Services and Active Ingredients section focuses on the Company's manufacture and marketing of APIs and intermediates. The Global Generics segment includes the Company's business of manufacturing and marketing prescription and over-the-counter finished pharmaceutical products ready for patient consumption, marketed under a brand name (branded formulations) or as generic finished dosages with therapeutic equivalence to branded formulations. 

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