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Moscow Discusses Market Regulation of Russian Biosimilars

28 February 2014

Lola Maksumova, Deputy General Strategy Director of GEROPHARM Group of Companies, attended the 2nd annual Adam Smith Conference Pharmaceutical Regulatory Affairs and Legal Aspects in Russia: Identifying Problems and Solutions

It is for the second year when the event gathers representatives of the competent regulatory authorities of Russia, as well as leading industry experts to discuss the most important legislative changes in the Russian pharmaceutical market.

The second day of the conference began with a panel discussion devoted to the establishment of a platform for biosimilar regulation harmonized with the EUCOMED recommendations and approaches used by leading foreign regulators.

The section was opened by Medical Director of the Norwegian Medicines Agency Steiner Madsen who shared Norwegian experience in building the state regulatory system in the pharmaceutical market. His speech caused intense debate among the panelists who discussed the specifics of registration of biosimilars and their market launch in Russia.

Deputy General Strategy Director of GEROPHARM Group of Companies Lola Maksumova emphasized the importance of and the current need for Russia to determine clear, simple and transparent rules for registration of biosimilars which should differ from the regulatory system of chemical generics; biosimilars require a differentiated approach to. Pharmaceutical regulation in developed countries is based on this principle. There are common rules for the total volume of chemical generics which are small molecules and can be identified by their INN, and there are also separate manuals for various classes of biopharmaceuticals and biosimilars which are complex molecules and cannot be regulated by the unified standards due to significant differences in their production and action mechanisms on human. Therefore, it is important that there was a single declarative law on circulation of medicines, as well as regulations or guidelines which should specify all procedural aspects for specific groups of drugs.

“Transparency of the process is beneficial to everyone. The simpler, more correct and detailed the process description is, the faster a new drug will be put on the market by the manufacturers, since there are less number of rejections, the more biosimilars in the market will appear and the more affordable their price will be. The market needs biosimilars as they support competition. The wider the choice is the lower price of the drugs is,” says Lola Maksumova. “Our main goal is to provide the Russian market with domestic drugs of high quality. In addition, compliance with European guidelines will allow domestic preparations to enter the foreign markets.”

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