Celltrion announced on April 29 that it received approval to sell Remsima from the Instituto Nacional de Higiene Rafael Rangel (INHRR), the National Institute of Health in Venezuela. Accordingly, the company can now sell the product in 13 out of the 22 countries in South America.
Since large markets such as the recently licensed Brazil and Mexico are included in the 13 countries, they account for nearly 80 percent of the South American TNF-alpha inhibitors market worth a total of 1.7 trillion won (US$1.59 billion). Therefore, sales will be accelerated from this year in South America where the best-known examples of pharmerging countries are located.
Venezuela has a population of approximately 30 million and the TNF-alpha inhibitor market for medicines like Remsima is worth about US$400 million (400 billion won). As the country is the leading power of MERCOSUR, a sub-regional bloc comprising 12 South American countries including Argentina, Chile and Uruguay, for free trade and economic cooperation in South America, Venezuela can be a strategic position for Remsima to expand its South American markets.
Due to the fact that South American countries are heavily dependent on imported medicine and medical supplies, they maintain very complex procedures to approve medicines. It takes a long time to be approved. Biosimilars lower the financial burden, unlike other costly imported medicines. When the Venezuelan government, the country which leads an open market and deregulation in MERCOSUR, positively assess the effects of biosimilar products after the introduction of Remsima, it is expected that Remsima will create a momentum to tap into the other South American countries.
Also, more than 90 percent of the prescription medicine market in Venezuela is subject to a state-run bidding process. Since the country is recently struggling to perform finance management due to the falling oil prices and the skyrocketing currency exchange rate, Remsima with its competitive price will have an advantage in the state-run bidding market.
An official from Celltrion said, “Even government officials expect that Remsima will positively affect the financial management of Venezuelan health insurance. We hope that the approval of Remsima will allow biosimilars to be widely used in South America, including Venezuela, as well.”
In Venezuela, Oli-Med, which sells medicines in 18 countries of the South American region, will take charge of sales of Remsima. The company currently sells biosimilar products from multinational pharmaceutical companies, including Genzyme, Sandoz, and Novo Nordisk, and it is strong enough in bidding to win all the medicine bids of the Venezuelan government in 2009.