BIOCAD (St. Petersburg, Russia) announced that its rituximab biosimilar Acellbia has received recommendation for approval in India by the Central Drugs Standard Control Organization. Acellbia is set to receive permanent market authorization (MA) in India by August this year, with its first shipment expected in September 2017.
The biosimilar Acellbia has been demonstrated to have a similar efficacy and safety compared to the reference drug rituximab (originally developed by Roche) during international clinical trials, which were conducted in accordance with EMA guidelines for non-clinical and clinical development of biosimilars.
The Russian biotechnology company has already had its rituximab biosimilar authorized in seven countries and has registration pending for a further 27 countries. The approval of Acellbia into the Indian market is representative of a significant strategic milestone for BIOCAD’s international expansion.
Currently the Indian market for rituximab – a drug used to treat autoimmune diseases and some types of cancer – is approximated to exceed US$40 million with an 8% annual growth. It is hoped that the introduction of Acellbia to the market can spur competition in the industry and will enable a larger number of patients in India access to this type of treatment.
Dmitry Morozov, CEO of BIOCAD, commented: “We are happy to see Acellbia, our first biosimilar drug product to receive MA in India, but our efforts to register more products there will continue. In the first quarter of 2018 we plan to obtain MA for Herticad, BIOCAD’s trastuzumab biosimilar which is used to treat certain types of breast cancer, and is already supplied to Syria, Sri Lanka and other countries.”