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Bioepis secures FDA approval for Ontruzant

Jan 22,2019
Samsung Bioepis gained U.S. Food and Drug Administration (FDA) approval for its oncology biosimilar Ontruzant, the pharmaceutical firm announced Monday.

Ontruzant is the company’s first oncology biosimilar to gain FDA approval. It is expected to be distributed in the United States by Merck from later this year.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.

Ontruzant is the third copycat version of Herceptin - the Swiss-based Roche’s hit brand of trastuzumab, which treats breast and metastatic stomach cancer - to be approved by the FDA. The other Herceptin biosimilars with FDA approval are U.S-based Mylan’s Ogivri and Celltrion’s Herzuma.

Samsung Bioepis, along with Mylan and Celltrion, are expected to start U.S. sales of the biosimilar after June when Herceptin’s U.S. patents expire.

Herceptin’s annual sales today are estimated at around 8 trillion won ($7.1 billion) globally, with some 3 trillion won raised from the United States alone. The launch of the biosimilar in the U.S. market can help bring cancer treatment costs down by introducing competition.

“For many cancer patients in the United States, battling cancer has not only been a health issue, but a considerable financial burden,” said Pak Sang-Jin, senior vice president and head of commercial division at Samsung Bioepis. “Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden. We sincerely hope our trastuzumab biosimilar will do exactly that.”

Since getting the green light from the European Commission in late 2017, Samsung Bioepis has been selling Ontruzant in Britain since last March as the first Herceptin biosimilar to be sold in the country.

Samsung Bioepis is a joint venture by Samsung BioLogics and U.S.-based Biogen. Its Renflexis, a biosimilar to rheumatoid arthritis treatment Remicade, is also FDA-approved and currently being distributed in the United States through Merck. Renflexis is sold at a 35 percent discount compared to Remicade.


BY KIM EUN-JIN AND LEE SOO-KI [kim.eunjin1@joongang.co.kr]


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