Korean biosimilar makers will find it more critical to achieve meaningful results in the U.S. after securing a larger market share in Europe, an analyst said.
In Europe, Korean biosimilar manufacturers are performing well. Celltrion’s Remsima (infliximab) garnered over 50 percent market share and Samsung Bioepis’ Benepali (etanercept), over 30 percent, in Europe.
However, their growth is relatively weak in the U.S., according to Heo Hye-min, an analyst at Kiwoom Securities.
“Since investors have developed higher standards for biosimilar companies after some firms’ quick infiltration into the drug market, their success and growth in Europe is not surprising news anymore. The market is turning the eyes to the U.S. where biosimilars are sold at higher prices,” Heo said in her report on Wednesday.
Although Europe has a relatively smaller market share of 25 percent in the global original biopharmaceutical market, a majority of the biosimilar products are sold in Europe, according to Heo.
Thus, the U.S., where most of the original biopharmaceutical products are sold, is the opportunity market for Korean biosimilar makers, she emphasized.
“The U.S. accounts for 62 percent of the original biopharmaceutical products but takes up only 3 percent of the biosimilar market. In the first half, 36 biosimilars were released in Europe and 12 products won a license in the U.S., but only four of them were launched due to patent lawsuits,” Heo said.
She went on to say that the U.S. has a higher potential for growth than Europe because the price competition among biosimilars in the U.S. was not as severe as in Europe where prices already started to go down.
However, the possibility of further price cuts, lack of education of biosimilars and restrictions on biosimilars as substituted drugs, and original drugmakers’ defense strategies such as rebates could make it difficult for biosimilar makers to infiltrate the U.S. market, she noted.
“In the U.S., there is not enough education on biosimilars to change people’s perceptions about biosimilars, and no biosimilar has received approval for a substituted prescription drug,” Heo said.
She explained that the U.S. Food and Drug Administration had said in July that it was preparing a final draft of the guidelines for prescribing biosimilars as substituted medicines. This signaled that the FDA would announce a measure to curb anti-trust activities of the pharmaceutical industry, Heo added.
“As the FDA also emphasized reinforcing education to boost understanding of biosimilars, the upcoming announcement of the FDA will help determine whether the market environment for biosimilars will improve,” the analyst said.
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