On June 6 2017 BIOCAD reported that it has obtained a marketing authorization for its rituximab biosimilar in Bolivia and Honduras under the trade name USMAL (Press release, Biocad, JUN 6, 2017, View Source [SID1234527805]). First shipments will start in the beginning of the third quarter of 2017. BIOCAD will be able to supply as much rituximab as needed for Bolivian and Honduran patients. Considering competitive price of the Russian biosimilar, estimated drug availability will double.
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Rituximab has become the first BIOCAD product to enter Latin America, which is strategically important for further business development in the markets of the MERCOSUR and other countries in region. Now the drug is being registered in other countries of this region and by the end of 2017 BIOCAD is expecting to get two more marketing authorization certificates.
The launch of the Russian biosimilar in the Bolivian and Honduran markets, where only originators are present, will provide the patients with an access to affordable and highly effective treatment of cancer, thus improving their life quality and expectancy.
High quality of Russian rituximab has been demonstrated in large-scale international clinical trials involving patients from Russia, Ukraine, Belarus, India, South Africa and Columbia. Starting from 2011 pharmacological properties of the biosimilar, as well its efficacy and safety have been extensively studied in the clinical development program in patients with lymphoma and those with severe rheumatoid arthritis. The equivalence of the Russian drug to the originator has been supported by multiple physicochemical and biological studies conducted in line with EMA guidelines and ICH philosophy.
With its production capacity, BIOCAD is ready to realize the export potential and stably supply high-tech biosimilars. Growing internationally, BIOCAD successfully ships rituximab biosimilar to seven countries, including Kazakhstan, Vietnam and Sri Lanka. The next step for expanding Latin American markets will be the launch of trastuzumab and bevacizumab biosimilars that already have marketing authorizations and are being distributed in other countries.