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Russian biotechnology company BIOCAD plans to enter the European market with oncological and autoimmune medicines.
Russian biotechnology company Biocad plans to enter the European market with oncological and autoimmune medicines, the company announced in an Oct. 25, 2017 press release. To date, the company has seven molecules in its European portfolio, including both innovative and biosimilar products for treatment of melanoma; breast, stomach, kidney, and lung cancer; rheumatoid arthritis; psoriasis; and multiple sclerosis. The company also continues to negotiation with its Japanese pharmaceutical partner regarding distribution of its products in Japan.
According to the company, it is ready to provide dossiers for its medicines according to the International Council for Harmonization Common Technical Document format, and also has a production plant in Turku, Finland.
Preparations are underway for conducting European Phase III clinical trials of the company’s adalimumab biosimilar and the original anti-IL-17 molecule. The preliminary agreement for the distribution of adalimumab in the European Union countries is scheduled to be signed in Frankfurt at the CPhI exhibition.
"As for the EU countries, where the approval of biological product goes under centralized procedure through the European Medicines Agency, taking into account the need for local clinical trials, we expect to get marketing authorization for biological products in 2021," said Dmitry Morozov, general director of Biocad, in the press release. In addition, in 2021, the generics of oncology drugs docetaxel, paclitaxel, pemetrexed, and irinotecan will also enter the European market, the company estimates.