WHO and Russian Federation to cooperate toward standards for evaluation and registration of biotherapeutic and biosimilar medicines in Russia

Moscow, May 16,2013. Today several countries have regulatory requirements in place for the development and evaluation of biotherapeutic and biosimilar medicines. The European Union, for example, provides unified standards and guidelines that are effective in the entire region. In Russia, on the contrary, these topics are not yet regulated. This is one of the key points that international and Russian experts are discussing in the context of the two-day workshop Biotherapeutic Medicines – Regulatory Challenges and Current Practices. Approaches for Harmonization.

This conference, taking place in Moscow, is the first of its kind to take place in the Russian Federation, and is attended by more than 300 members of the international expert community, including leading specialists from Russia; Belarus; Kazakhstan; Ukraine; the World Health Organization (WHO); Health Canada; European regulatory agencies; and industry. 

On the opening day of the workshop, Dr.Ivana Knezevic, World Health Organization said, “We have been jointly working and collaborating with the authorities of the Russian Federation for more than 30 years on the standardization and regulatory evaluation of vaccines. The dialogue on biotherapeutic and biosimilar medicines has been encouraging, and we hope that this conference will serve as a shared platform for a productive collaboration on this topic.” 

Elena Maksimkina, Director of the Russian Health Care Ministry’s Department for State Control over Drug Circulation, also stressed the vital importance of cooperation with international organizations, “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.” 

The conference is organized by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in cooperation with the Association of International Pharmaceutical Manufacturers (AIPM). It is held with the support and participation of the Ministry of Health of the Russian Federation, the Russian Federal Service for Healthcare Supervision, the Eurasian Economic Commission, the State Duma Committee on Health Protection, and the Russian Academy of Medical Sciences.  

About AIPM:

The Association of International Pharmaceutical Manufacturers (AIPM) comprises more than 50 international pharmaceutical companies operating in Russia that provide over 80% of the world’s pharmaceutical products and over 60% of medicine imported to the Russian Federation. 

For further information, please contact:

Alexey Shavenzov, AIPM

Tel +7 495 933 7040 (ext 102), mob +7 916 294 9031, a.shavenzov@aipm.org

Tatiana Gavrilenko, AG Loalty

Tel +7  499 788 91 57, mob +7 926 796 2939, tgav@ag-loyalty.com