Dr Reddy's completes clinical studies of key biosimilar, step closer to launching in US, Europe

Dr Reddy's Laboratories Limited on January 20 announced the successful completion of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in the United States, Europe and other regions.

The company said DRL_RI is being developed as a biosimilar of rituximab, a cytolytic antibody, for various illnesses including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

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The Hyderabad-based pharma player said it would now prepare to file Biologics License Application (BLA)/ Marketing Authorisation Application (MAA) dossiers with various regulatory authorities in the United States, European Union and other regions.

“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,” Dr Reddy’s global head of biologics Jayanth Sridhar said.

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According to the pharma major, rituximab biosimilar has been approved for marketing in India and over 25 emerging markets and the company undertook further clinical development to meet regulatory requirements of these highly regulated markets.

The company is collaborating with its partner Fresenius Kabi to commercialise its proposed biosimilar of rituximab in the United States.

But it intends to commercialise the proposed biosimilar in the European Union and other regions directly.

Dr Reddy’s has six portfolios of commercial products marketed in India and more than 25 emerging markets. The company said it has several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches.

The firm is also ramping up manufacturing capacity in biosimilars business to support global expansion plans.

According to European Medicines Agency (EMA), a biosimilar is a biological medicine quite similar to another already approved biological medicine.

Biological medicines offer treatment options for patients with chronic and often disabling conditions such as diabetes, autoimmune disease and cancers. These medicines contain active substances from a biological source, such as living cells or organisms (human, animals and microorganisms such as bacteria or yeast) and are often produced by cutting-edge technology.

At 10.40 am, Dr Reddy's was trading at Rs 4,377.30 on the National Stock Exchange, up nearly 1 percent. For the year, the stock has gained over 3 percent.