Korean biosimilar drugs lift European market share

By Choi Sung-jin

Domestic biosimilar products are rapidly expanding their market share in many European countries and industry watchers are wondering whether the Korean makers also will be able to duplicate their success in U.S. markets.

Biogen, a U.S. multinational biotechnology company, announced its second-quarter results last Friday, including the sales records of Benepali, an arthritis drug developed by Samsung Bioepis and marketed by it in Europe. The second-quarter sales of Benepali totaled about 17 billion won ($15 million), an increase of 7.5 times from the first quarter, Biogen said.

Samsung Bioepis is expected to record sales of almost 100 billion won from Benepali alone. Samsung Bioepis has been making Benepali, its first biosimilar product, in Biogen’s factory in Denmark. As its sales increase, however, the firm has signed a contract with its parent company, Samsung Biologics, for the production of the biosimilar medicine, company officials said.

Sales of Inflectra, a rheumatoid arthritis treatment developed by Celltrion and marketed by Pfizer in Europe since 2013, are also growing steeply.

Its share in the Norwegian market, for instance, was 9 percent in February but soared to 93 percent in April. The Oslo government reportedly is encouraging use of the biosimilar medicine to save money in its medical budget.

Particularly, Celltrion’s biosimilars are expanding their markets from Northern Europe to Western Europe. “The market shares of Inflectra have reached 97 percent in Denmark, 88 percent in Finland, 33.5 percent in Sweden, 27 percent in the Netherlands, 14 percent in Germany and 11 percent in France,” said Steinar Madsen, a medical director in the Norwegian government.

The Korean companies’ robust performances in European markets are attributed to their swifter obtaining of permissions than their foreign competitors. They are contacting foreign governments and hospitals with global pharmaceutical companies as their marketing partners, offering bold price discounts. The brisk sales of Korean biosimilars in Europe are prompting other Korean firms to make additional applications for permission.

Unlike Europe, however, sales of Korean biosimilar medicines in the U.S. market will likely face an uphill battle, industry executives said.

Fortunately, patent disputes are almost over for Remicade's biosimilars, for which domestic companies have completed development and won marketing permission. Celltrion has obtained permission for its biosimilar medicine Remsima, and Samsung Bioepis applied to the U.S. Food and Drug Administration (FDA) for its medicine in June.

Although an FDA advisory body has recommended permission for biosimilars developed by Novartis and Amgen, their sales at market may not be easy, industry experts said. According to Bio Century, a market research agency, Abbvie, the marketing company of Humira, alleges its substance patent continues through 2022. Major patents for another original medicine, Enbrel, also expired in 2011 but its developer, Amgen, claims its patents should be protected until 2029.

Even if Korean companies can surmount high patent barriers, they face fierce competition with foreign rivals because there are as many as 16 biosimilars for Humira. And companies that have developed two of the 16 biosimilar products have already applied for FDA permission – Biocon, an Indian company, has applied by teaming with Italy’s Milan, and Coherus of the United States has submitted its application.

Indian and Chinese companies are strong challengers. Zydus Cadila and Reliance, two Indian pharmaceutical companies, are already selling Humira’s biosimilars in their domestic market. 3S Bio, a Chinese company, has begun marketing its product in China and India.

These biosimilar medicines are ready to challenge in U.S. markets, emerging as strong competitors for Korean companies, the experts said.