UPDATE : Wednesday, December 12, 2018
EU approvals for Samsung Bioepis push up share prices
  • By Nam Doo-hyun
  • Published 2017.09.18 14:45
  • Updated 2017.09.18 14:45
  • comments 0

Investors are showing higher expectation for Samsung Bioepis, a Samsung Group unit that has secured the licenses to make four biosimilars out of top 10 selling drugs in the world.

After Samsung Bioepis삼성바이오에피스 won the approval of European regulators for its SB3, a copy of Swiss drugmaker Roche’s breast cancer drug Herceptin, the company is likely to receive additional European approvals on its other biosimilars that have been fully developed, industry watchers said.

SB3, one of the company’s six pipelines, received “positive opinion” from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Sept. 15, local time. Samsung Bioepis said it would market SB3, named Ontruzant, in Europe by Merck.

If Samsung Bioepis receives a sales approval on Ontruzant, it will become a maker of four biosimilars of the 10 best-selling drugs regarding global sales, the company said.

The company’s latest winning the EU endorsement has helped push up shares of Samsung Biologics, the parent company of Samsung Bioepis, analysts said.

The stock price of Samsung Biologics closed at 326,500 won ($288) on Sept. 15, continuing to surge since it went public in November 2016.

Its shares jumped 126.7 percent as of Friday from 144,000 won on Nov. 10, 2016. This year, it soared 108.6 percent as of Friday. This month alone, it rose 16.4 percent as of Friday from 285,000 won on Sept. 1.

Analysts attributed the high rise of Samsung Biologics’ shares to its contract manufacturing organization (CMO)-based growth following the construction of a third factory, and Bioepis’ winning of the biosimilar approval which brightened prospects for the sales increase.

“Local institutional investors have bought stocks of Samsung Biologics since July,” a local analyst said. “I don’t know when the SB3 will get the final sales approval, but many say that it will be within this year. Investors would have wanted to secure more stocks in advance.”

Usually, the CHMP’s positive opinion affects the EMA’s sales approval. Samsung Bioepis hopes to get the approval within two or three months.

Samsung Bioepis has six pipelines – SB2 to SB5, SB8, and SB9. Enbrel biosimilar SB4 (Brenzys, ingredient: etanercept) received a European endorsement in January, Remicade biosimilar SB2 (Renflexis, infliximab) in May, and Humira copy SB5 (adalimumab) in August.

SB9, Bioepis’ version of Lantus, funded by Bioepis and developed by Merck, received approval in January in Europe. Avastin copy SB8 (bevacizumab) is on phase 3 clinical trial for the treatment of colorectal cancer and lung cancer.

This year, Samsung Bioepis is likely to gear up its global sales of its biosimilars referencing best-selling global products – AbbVie’s Humira, the top seller with 16 trillion won in global sales in 2016, Pfizer/Amgen’s Enbrel ranking four to fifth with 8.8 trillion won in global sales and Roche’s Herceptin ranking eighth with 5.8 trillion won in sales.


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