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Russia Working to Align Biologics Regs with International Standards

By Gareth Macdonald , 20-May-2013

Russia Working to Align Biologics Regs with International Stanadards
Russia Working to Align Biologics Regs with International Stanadards

Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.

The meeting – co-hosted by the IFPMA and AIPM – provided the opportunity for staff from the WHO, representatives from various national drug regulatory agencies and several pharmaceutical companies to discuss how best to develop a set of rules that align with those established elsewhere.

AIPM spokesman Alexey Shavenzov told in-Pharmatechnologist.com that: “The European Union has had a very well structured and defined regulatory framework in place for biotherapeutic medicines, including biosimilars, for several years.

This Workshop is for us the occasion for a structured dialogue with those authorities - such as the World Health Organization; the European Union; and many others - who already have such frameworks in place.”

Biosimilars

This was echoed by Ivana Knezevic of the WHO’s quality, Safety and Standards Committee, who told us the meeting builds on a 30 year history of collaboration with Russian Federation and added that “the dialogue on biotherapeutic and biosimilar medicines has been encouraging.”

Specific details of topics discussed at the event have not yet been released, although comments by Elena Maksimkina, director of the Russian Health Care Ministry’s Department for State Control over Drug Circulation, suggest that biosimilars were a key focus.

She told this publication that: “At present we are introducing the definition of biosimilar medicines into legislation and discussing the respective standards and rules of regulation, which includes the issues of interchangeability, choice of reference drug for evaluation.”

Russian regulations

Oddly, for a country whose pharmaceutical market has long been dominated by generic drugs, the concept of a biosimilar is not yet recognised in Russian law and any such products that are submitted to regulators are not eligible for expedited review.

Igor Stefanov, director of Moscow contract research organisation (CRO) Synergy Research Group, told in-Pharmatechnolgist that: "The law uses the term "immunobiological drug" – drug of biological origin intended for immunological diagnosis, prevention and treatment of diseases. The concept of biosimilar is missing."

He added that instead: “Biosimilars are considered by regulators as brand-name drugs with all the ensuing consequences.”

Whether this will change as a result of decisions taken at the joint IFPMA-AIPM meeting is unclear. 

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