April 20, 2024

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[THE INVESTOR] Samsung Bioepis said on Nov. 20 it has received marketing authorization for Ontruzant, its version of Roche’s blockbuster breast cancer treatment Herceptin, in Europe.

Ontruzant is the first biosimilar referencing Herceptin approved by the European Commission, outpacing Samsung Bioepis’ competitors such as Amgen and Allergan as well as crosstown rival Celltrion. 

“Breast cancer remains the most common form of cancer affecting women. We hope Ontruzant will play an important role in expanding patient access to trastuzumab across the region,” Samsung Bioepis CEO Ko Han-sung said in a statement.

Shares of Samsung BioLogics, Bioepis’ parent company, rose 3.28 percent in early morning trading.

Switzerland-based Roche raked in 6.78 billion Swiss francs (US$6.78 billion) in 2016 from Herceptin, with about US$2 billion in the European market. Roche’s EU patents for Herceptin expired in 2014.

Ontruzant is the company’s first biosimilar for use in oncology and will help expand its pipeline from autoimmune disease-focused therapies. With the green light, Samsung Bioepis now has received four biosimilar approvals in the EU in less than two years, including its versions of Amgen’s Enbrel, Johnson & Johnson’s Remicade and AbbVie’s Humira.

Celltrion filed for approval with the European regulator in October last year while Amgen and Allergan followed suit in March. Ontruzant will be commercialized by the Korean company’s sales partner MSD.

Pressure is mounting on Roche, the world’s biggest maker of oncology treatments, as its three cash cow therapies -- Rituxan, Herceptin and Avastin -- are facing biosimilar competition. The three cancer medicines generate more than half of Roche’s pharma business. Samsung Bioepis is also developing a biosimilar referencing Avastin, which is undergoing phase 3 clinical trials.

As patents of older drugs start to expire, Roche is betting on new medicines. In November, Roche’s Hemlibra, a treatment for hemophilia A, got the nod from the US Food and Drug Administration while its multiple sclerosis therapy Ocrevus got a positive opinion from the European Medicines Agency.

By Park Han-na (hnpark@heraldcorp.com)