The Central Drugs Standard Control Organization of India (CDSCO) approved for registration the first rituximab biosimilar fully manufactured by BIOCAD, a Russian biotech company. The supplies of the medicine are scheduled to begin in September 2017.
This August, BIOCAD will obtain a permanent marketing authorization for this drug in India. Currently, the market of rituximab in India grows by 8% a year and is worth over $40 million. According to experts, in five years, this figure will increase to $58 million.
“Rituximab has become our first drug in India, but we are not going to stop at this. In Q1 2018, the company plans to register a trastuzumab biosimilar for the treatment of breast cancer, which is already being actively supplied to Syria, Sri Lanka and other countries,” said Dmitry Morozov, the CEO of BIOCAD.
The quality of Russian medicine was confirmed by large-scale international clinical trials which, among other countries, have been also conducted in India. The trials were conducted in accordance with the recommendations of the European Medicines Agency (EMA) for preclinical and clinical development of monoclonal antibody biosimilars. The trials proved the therapeutic equivalence of the Russian biosimilar to the original drug manufactured by Roche.