Korean biosimilars maker Celltrion announced that it has received approval to sell Remsima from the Ministry of Health of the Russian Federation (Minzdrav) on July 13. The company’s marketing partner EGIS will be in charge of sales in the Russian Federation, and the product will be put on the market with the name “Flammegis” in the country.
It took about two and a half years to receive approval, since Celltrion submitted a biologics license application for Remsima in Jan. 2013. It is required for clinical trials to be conducted on Russians within the country in order to register medicinal products in Russia. Since Russia has stringent requirements and complicated procedures, it is very difficult to export a pharmaceutical product there. However, Russia is one of the most important countries for medicine export, as it has the largest economy among the Commonwealth of Independent States (CIS), a large pharmaceutical market, and a strong influence on neighboring countries.
Currently, Russia’s TNF-alpha blocker market is worth US$72 million (81.5 billion won), which is not big compared to the size of the economy. However, it is one of the most typical “pharmerging” countries, which drug market is growing 10 to 15 percent every year. Also, most purchases of ethical drugs are made through bidding by the federal and state governments, so biosimilars with price competitiveness will be at an advantage.
An official from Celltrion said, “Russia has a strong influence among CIS countries and all CIS countries’ pharmaceutical market is growing steadily. We think that Russia’s approval for Remsima will draw CIS countries’ attention to the product.” Currently, Remsima is on sale in 7 out of 10 CIS countries. When the sale begins in Russia, Remsima can be prescribed in all CIS countries except for Kyrgyzstan and Tajikistan.