In 2009, the World Health Organisation (WHO) Expert Committee on Biological Standardisation adopted the WHO guidelines on evaluation of similar biotherapeutic products (biosimilars) with a description of a set of globally acceptable principles regarding regulatory evaluation of such products. In 2013, the Committee developed and adopted WHO guidelines on the quality, safety, and efficacy of biotherapeutic protein products prepared with recombinant DNA technology. Furthermore, in 2014, the 67th World Health Assembly (WHA) adopted a resolution on high priority needs in provision of biotherapeutic products (including similar biotherapeutic products) in order to promote access to these products, as well as to ensure their quality, safety and efficacy (WHA 67.21). This WHO resolution suggested supporting national regulatory authorities in developing national regulatory frameworks to meet applicable international regulatory expectations.
As one of the steps towards implementation of the principles set in two WHO guidelines, the first implementation workshop for Russian-speaking countries in the European region was held on July 5-7, 2017 in Copenhagen, Denmark. 30 participants representing regulatory agencies from Azerbaijan, Armenia, Russia, Georgia, Ukraine, Kazakhstan, Kyrgyzstan, Moldova, and Tajikistan took part in the meeting. Our republic was represented by the specialists of Centre for Examination and Tests in Health Service Unitary Enterprise.
The workshop objectives were to discuss key regulatory issues relevant to assurance of quality, safety and efficacy of biotherapeutic products with regulators; to provide a forum with experts for questions and answers related to the implementation of WHO guidelines; to gain an understanding of the needs and desires of the participants for possible holding of workshops. Leading experts such as WHO consultants, an expert from a Great Britain regulatory agency, representatives of International Federation of Pharmaceutical Manufacturers & Associations delivered reports for the participants of the workshop. Participants sharpened their skills in biosimilar master file expertise as a part of a case study during the practical part of the workshop. During a closed part of the workshop, each Member State presented its report on the current situation in the area of legislative framework and regulatory procedures on authorisation of biotherapeutic products, as well as similar biotherapeutic products.
At the end of the workshop, representatives of the countries unanimously spoke in favour of necessity of further cooperation under the auspices of WHO in the area of authorisation of these medical products.