Russian biotechnology company, BIOCAD, has revealed plans to enter the European market with oncological and autoimmune medicines.
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Currently, the company has seven molecules within its European portfolio that are biosimilar products for potential application in the treatment of melanoma, breast, stomach, kidney and lung cancer, rheumatoid arthritis, psoriasis and multiple sclerosis.
“The presence of Russian innovative medicines on the European market depends on the speed of approval process in the EMA (European Medicines Agency) which correlate with readiness to provide sufficient documents from manufacturer. BIOCAD is the only pharmaceutical company in Russia, which is ready to provide dossiers for its medicines according to ICH CTD format in the shortest possible time,” said Dmitry Morozov, general director of BIOCAD biotechnological company during the CPhI congress in Frankfurt last week.
At the moment, the company has biosimilars, generics and original molecules in its pipeline. The company invests in clinical trials for all its products and preparations are currently underway for conducting European Phase III clinical trials of adalimumab biosimilar and the original anti-IL-17 molecule.
“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,” Morozov added.