Korean biosimilars making a splash on world stage

South Korea's top two biosimilar makers are shaking up the global market with recent approvals for lower-cost biologics in Europe and a pending approval for another in the United States.

The companies, Celltrion and Samsung Bioepis, are encroaching on territory long dominated by European and American drugmakers and their progress is seeing their market values soar.

Samsung Bioepis said Sunday its Benepali biosimilar of Amgen's ($AMGN) rheumatoid arthritis drug Enbrel was approved in Europe and then Celltrion said the U.S. Food and Drug Administration (FDA) was scheduling meetings to consider approving its Remsima biosimilar of Remicade.

Celltrion saw its market value soar to $10.7 billion after the news, according to a report by the Korea Herald.

Samsung's Benepali is the first Enbrel biosimilar to be approved in Europe where the drug, marketed by Pfizer ($PFE), makes up $10 billion in sales of all biologics in the region, the Korea Herald said. Benepali should cost patients about 30% less than Enbrel.

Celltrion, for its part, has already been selling its Remicade biosimilar in Europe under the name Infectra since early 2015 and hopes the U.S. FDA meetings in February will give it the greenlight for U.S. sales.

Remsima is the biosimilar to Johnson & Johnson's ($JNJ) Remicade which is used to treat autoimmune diseases. Johnson & Johnson's patent on Remicade is due to expire in 2018, but a recent rejection by the U.S. Patent Office has led to an appeal by the company.

Johnson & Johnson is facing a tremendous loss of revenue once Remsima hit the U.S. market, as most expect it to. Celltrion will likely sell the biosimilar for up to 40% less than Remicade. When Celltrion's biosimilar hit markets in Europe, Johnson & Johnson saw sales fall to $580 million in 2015 from $783 million in 2014, according to the Korea Herald report.

An analyst at Citigroup said last year that drug developers could lose up to $360 billion in revenue over the next 10 years and that biosimilar makers could take in about $110 billion of that lost by the pharma majors, the Korea Herald reported.

- here's the report from the Korea Herald

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