Celltrion gets green light in EU for drug

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Celltrion gets green light in EU for drug

Biopharmaceutical company Celltrion said its antibody drug Remsima has won approval by the European Medicines Agency, paving the way for the local drugmaker to export the drug to 30 countries in Europe.

This is the first time that the Korean biopharmaceutical company got the green light to sell overseas after the Korea Food and Drug Administration (KFDA) approved the biosimilar last year.

Celltrion has invested a combined 200 billion won ($180 million) since first developing the material for the biosimilar in 2006. It finished global clinical tests last year.

“Remsima has the same medicinal benefits as the original drug and it’s cheaper,” Celltrion Executive Vice President Kim Hyung-ki said at a press conference yesterday. “Remsima can benefit countries that feel a financial pinch for medical expenditures. Countries in western Europe such as Italy and Spain are interested in the product.”

Remsima is a biosimilar version of Johnson & Johnson’s Remicade, a well known medication for rheumatoid arthritis.

Biosimilars are effectively copies of innovative biopharmaceutical products made from substances extracted from the human body, but with variations from the original. They are distinct from generics, which copy the chemical ingredients of patented drugs. Celltrion is the world’s first company to successfully produce a biosimilar.

U.S. drugmakers Pfizer and Amzen, Israel’s Teva, Switzerland’s Sandos and Korea’s Samsung Biologics are in the process of developing biosimilar.

“Given that there is no company in the world that finished clinical tests on a biosimilar for antibody treatments [except us], Remsima is expected to monopolize the global market for the next three to four years,” Kim said.

Market observers said the EMA’s approval has provided great momentum for the sale of Celltrion. In April, Celltrion President Seo Jung-jin said he will sell his controlling stake in the Kosdaq’s No. 1 market cap company by seeking a buyer among multinational drugmakers. He cited predatory short-selling as the main reason behind the move. The company has appointed JPMorgan as lead underwriter for the sale.

According to market observers, global demand for biosimilars is forecast to grow to $31 billion over the next eight years as patents for original biopharmaceutical products are due to expire, according to the U.S. Generic Pharmaceutical Association.

Celltrion’s stock price closed at 41,800 won, up 6.77 percent, even though the press conference was held after the market close.

BY KIM MI-JU [mijukim@joongang.co.kr]

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