Korean biosimilar products are still struggling to penetrate the U.S. market, as opposed to their rapid growth in Europe, an analyst report said Wednesday.

According to the report by Korea Investment & Securities, major biosimilars recently released by Korean biopharmaceutical firms took up only 3.1 percent of the U.S. market.

Korean biosimilars targeting the U.S. patients include Celltrion’s Inflectra (branded as Remsima in Korea) and Samsung Bioepis’ Renflexis (Brenzys in Korea), both of them referencing Janssen’s Remicade, a treatment for autoimmune diseases.

Remicade’s dominance is formidable, boasting more than 97 percent of the U.S. market share. Despite a new competition with cheaper biosimilars, the original drug has been selling more than $6 million a month since February 2017.

In September last year, Remicade’s share hit as high as 98.5 percent, recording a monthly revenue of $710 million (749.9 billion won). In February, the medication still recorded a high market share of 96.8 percent.

Celltrion’s Inflectra, the world’s first biosimilar that is selling well in Europe, sold $190,000 in January and February, respectively, in the U.S.

Inflectra’s market share went up from 2.6 percent in January to 3.1 percent in February.

Samsung Bioepis’ Renflexis could not even reach a 1 percent market share. The drug’s share inched up from 0.05 percent in October last year to 0.08 in January, and to 0.12 in February. Its monthly revenue was about $713,000 (752 million won).

Renflexis’ U.S. performance fell short of industry expectations, compared to Remsima’s speedy growth in Europe. Remsima successfully beat the original by winning a market share of 52 percent in Europe. Cetllrion’s other biosimilar Truxima (rituximab) is selling well in the Dutch market with a 58 percent share, and the U.K. with a 43 percent share.

Celltrion and Samsung Bioepis attributed the underperformance of their biosimilars in the U.S. to different healthcare systems between the U.S. and Europe.

In Europe, most countries adopt a bidding system although there are some differences by country.

As physicians and hospitals prefer to prescribe drugs that won a state bidding, a drugmaker can boost its market share by winning a bidding.

Samsung Biopeis’ Benepali and Celltrion’s Remsima grew fast through biddings.

In the U.S., however, private insurance firms have a strong impact on the pharmaceutical market. With the original drugmakers’ strategy to delay insurance registration of rival biosimilars and engage in litigations, biosimilar manufacturers are struggling to enlarge their shares.

Korean biosimilar makers are anticipating a change in the U.S. government’s policy to enhance support for biosimilars.

Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration, said that the FDA was pushing for a policy to boost the sales of biosimilars, which languish in the U.S. compared to Europe, at Healthy Returns conference, hosted by CNBC in New York, on March 28.

“Global partner firms of Korean biosimilar makers are engaging in litigations against original drugmakers and a related association in the U.S. They are also pioneering a new market through various ways. Biosimilars’ weak sales in the U.S. came from the U.S. pharma system, so their share will gradually go up,” said a local pharmaceutical industry official.

Another source said, “Most of the litigations are now being settled. It takes some more time in the U.S. because the country does not adopt a bidding system like Europe. Biosimilar makers will benefit from the Free Trade Agreement between Korea and the U.S. and the U.S. support for biosimilars.”

sjh@docdocdoc.co.kr

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