BIOCAD presents its latest developments at the CPhI exhibition in Frankfurt on October 24 - 26, 2017. The top management of the Russian biotechnological company at the CPhI is discussing the issues of market access in EU and worldwide. BIOCAD will continue negotiations with the Japanese pharmaceutical partner and will discuss commercial terms and conditions for the distribution in the Land of the Rising Sun.
"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," says Dmitry Morozov, general director of BIOCAD biotechnological company. In addition, the advantage of BIOCAD is its own production plant, which the company builds in Finland, in the city of Turku.
Currently, the Russian pharmaceutical company BIOCAD has not only biosimilars and generics in its pipeline, but also original molecules for the treatment of oncological and autoimmune diseases. The company invests in clinical trials of all this products. The last preparations are underway for conducting European Phase III clinical trials of adalimumab biosimilar and the original anti-IL-17 molecule. The preliminary agreement for the distribution of adalimumab in the European Union countries is planed to be signed in Frankfurt at 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," says Dmitry Morozov. In addition, in 2021, the generics of oncology drugs - docetaxel, paclitaxel, pemetrexed and irinotecan - will also enter the European countries.
BIOCAD is interested in licensing innovative products from small companies on mutually favorable terms for the Russian market. During the visit to Frankfurt, Russian experts will discuss with their Swiss colleagues the prospects of collaboration on a drug against hard-to-treat chronic viral infections based on a molecule obtained in the laboratories of the Swiss company. In addition, the company plans to sign a preliminary agreement on the licensing of an immune-oncology molecule with a pharmaceutical company from Germany. This drug will be used in combination therapy of some cancers along with the original BIOCAD medicine.
BIOCAD is one of the world’s innovative biotechnology companies in Russia. Its leading excellence comes from the world-class R&D centers, modern biotechnological manufacturing facilities, as well as preclinical and clinical research infrastructure that corresponds to the international standards.
BIOCAD is a full-cycle drug development and manufacturing company, ensuring high-quality pharmaceutical development in all stages - from new genetic engineering to large-scale commercial production and further marketing support. The company provides original and generic drug products to treat complex health conditions such as cancer, HIV, multiple sclerosis, Hepatitis C infections, and other disorders.
The company employs about 1300 workers, including more than 450 researchers. BIOCAD has created subsidiaries and partnerships in the USA, Brazil, China, India, Vietnam and other countries.