Samsung Bioepis launches Europe’s first Herceptin biosimilar

By Sohn Ji-young

Published : Mar 9, 2018 - 15:22
Updated : Mar 9, 2018 - 15:22

Samsung Bioepis, the new drug development arm of South Korea’s Samsung Group, has launched its Herceptin biosimilar in the UK through its local marketing partner MSD, becoming the first company to bring a cheaper copy of the blockbuster anticancer drug to Europe.

MSD, also known as Merck & Co. in North America, announced Thursday that Ontruzant, the first biosimilar copy of Roche’s breast cancer therapy Herceptin (trastuzumab), had begun sales in the UK. Biosimilars refer to cheaper, near-replicas of biologic drugs whose patents have expired.

Samsung Bioepis employees work inside a lab at the company's headquarters in Songdo, Incheon (Samsung Bioepis)

Ontruzant’s commercialization comes around six months after the European Commission granted Samsung Bioepis marketing authorization for the biosimilar for the treatment of early breast cancer, metastatic breast cancer and metastatic cancer in November 2017.

Under the EC’s approval, Ontruzant can be sold in all 28 European Union states as well as the European Economic Area member states of Norway, Iceland and Liechtenstein. The UK is the first state for the Herceptin biosimilar to begin sales.

Ontruzant is the fourth biosimilar developed by Samsung Bioepis to obtain the EC’s approval and the first cancer-targeting biosimilar in its pipeline to do so.

The Korean drugmaker has already obtained approval for three additional biosimilar drugs in Europe, referencing Remicade, Enbrel and Humira respectively. They are all anti-TNF therapies targeting autoimmune diseases such as rheumatoid arthritis and Crohn’s disease.

The commercialization of Samsung’s Herceptin biosimilar is expected to eat into the sales of Roche, the developer of Herceptin. The breast cancer-fighting drug was the fourth top-selling biologic in the world in 2017 with worldwide sales of $7.4 billion.

In addition to Samsung’s Ontruzant, other Herceptin-referencing biosimilars are on track for swift launches in Europe. The closest competitor is Herzuma, developed by Korean biosimilar developer Celltrion.

Celltrion’s Herzuma was approved by the EC last month, marking the second Herceptin biosimilar to obtain regulatory approval in Europe. Once Herzuma hits the market, it is expected to engage in a price war with Samsung’s Ontruzant to gain an upper position in the Herceptin biosimilar market.

Other drugmakers including Myland and Biocon, Amgen and Allergan have submitted their own Herceptin biosimlilars to European drug regulators.

Nonetheless, Roche is still expected to defend its position in the Herceptin market, as it sells a patent-protected subcutaneous formation of the drug that offers more convenience to patients.

The SC version of Herceptin is estimated to represent 50 percent or more of the total Herceptin market globally. The Herceptin biosimilars that are being launched now are designed for intravenous injections only.

Samsung Bioepis was founded in 2012 as a joint venture between contract drug manufacturer Samsung BioLogics and US drugmaker Biogen. Biogen holds a 5.4 percent stake in Bioepis, while Samsung BioLogics owns the remainder of the shares.

By Sohn Ji-young (


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The Korea Herald by Herald Corporation