Russia to harmonize biologicals regulations

Biosimilars/News | Posted 31/05/2013 post-comment0 Post your comment

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.

picture23

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.

Related articles

Kazakhstan, Russia, Ukraine to change drug reimbursement schemes

Russian drug spending set to reach US$4 billion by 2020

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.

Source: IFPMA, WT100

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010