Dr Reddy's Laboratories on Friday said it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, 'DRL_RI' for filing in highly regulated markets such as the US, Europe and other regions.
In a BSE filing, it said 'DRL_RI' is being developed as a biosimilar of rituximab, for approval in the US, European Union and other regions for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Following completion of the full set of clinical studies, Dr Reddy's said it will now prepare to file in the US, European Union and other regions for approval of 'DRL_RI'.
It has already been approved for marketing in India and over 25 emerging markets.
"This is a very important milestone in our biosimilars journey. The successful completion and positive outcome of these clinical studies highlight 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.
The company said it is currently collaborating with its partner Fresenius Kabi to commercialise its proposed biosimilar of rituximab in the US. It intends to commercialise the product in Europe and other geographies directly.
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