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Russia to harmonize biologicals regulations Posted 31/05/2013

International regulatory bodies and the drug industry met in Moscow on 15 May 2013 to discuss how to harmonize Russia’s regulatory standards for biologicals with the rest of the world to develop a framework for pharma companies developing biologicals and biosimilars in Russia.

The meeting – Biotherapeutic medicines: regulatory challenges and current practices - approaches for harmonization – was hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in cooperation with the Association of International Pharmaceutical Manufacturers (AIPM). 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 also supported and participated in the meeting.

The meeting was the first international expert meeting of its kind to take place in Russia. It brought together experts from Belarus, Kazakhstan, Russia, Ukraine, the World Health Organization, Health Canada, several European national regulatory agencies and industry in an attempt to harmonize approaches for originator biologicals and biosimilar medicines.

Although Russia has a strong generics market, it has not yet developed a regulatory framework for biologicals or biosimilars. In fact, Russia has yet to define what a biosimilar is, and Russian Law does not yet recognize biosimilars as distinct products.

After the meeting Dr Elena Maksimkina, Director of The Ministry of Health of the Russian Federation’s Department for State Control over Drug Circulation, confirmed that the definition of biosimilars was being introduced legislatively, and that standards and regulations were being discussed, with particular attention to interchangeability and the choice of reference drugs for comparative evaluation.

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Source: IFPMA, WT100

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