Biotherapeutic Medicines Meeting
International regulatory authorities and representatives from the drug industry met in Moscow this past May in order to discuss how to harmonize Russia’s regulatory standards for biologic products and align them with international standards. The primary goal of the meeting, Biotherapeutic medicines: regulatory challenges and current practices – approaches for harmonization, was to develop a more standardized framework for pharmaceutical companies developing biologics and biosimilars in Russia. Several Russian healthcare ministries and authorities sponsored and participated in the meeting.
Defining Biosimilars in Russia
The first international meeting of this type to take place in Russia, it brought together not only experts from Russia but from neighboring countries such as Belarus, Kazakhstan, and Ukraine, as well as representatives from the World Health Organization, Health Canada, and several European national regulatory agencies and industries.
This meeting was very timely since although Russia already has a strong generics market, it has not yet developed a regulatory framework for biologics or biosimilars. To date Russian law does not define or recognize biosimilars as distinct products from their biologics counterparts. Following the meeting in Moscow, the Director of the Ministry of Health of the Russian Federation’s Department for State Control over Drug Circulation, Dr Elena Maksimkina, confirmed that legislature to define biosimilars is being established, along with new standards and regulations.
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