Regulators and representatives of Russia’s drug industry met recently with the goal of developing an outline of standards for the evaluation and registration of biotherapeutic and biosimilar medicines, which until now have been unregulated in Russia. The meeting, evidently the first of its kind to take place in the country, was co-hosted by the Association of International Pharmaceutical Manufacturers (AIPM) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and included representatives from Russia, Belarus, Kazakhstan, Ukraine, the World Health Organization, Health Canada, several European national regulatory agencies, and industry to discuss current challenges in regulating biotherapeutic and biosimilar medicines and exchange global best practices.
Elena Maksimkina, director of the Russian Health Care Ministry’s Department for State Control over Drug Circulation, stressed how important it is to cooperate with international organizations. She said, “At present we are introducing the definition of biosimilar medicines into legislation and discussing the respective standards and rules of regulation, which include the issues of interchangeability; choice of reference drug for evaluation; etc. Being a supranational body, the World Health Organization is a leading expert in this field. Now we have a chance to take the best international practices as a basis for developing Russian criteria for biosimilar medicines evaluation.” See Association of International Pharmaceutical Manufacturers News Release, May 16, 2013.