Success for Samsung Bioepis as EU welcomes first Herceptin biosimilar

By Dan Stanton

- Last updated on GMT


Related tags Samsung bioepis Monoclonal antibodies Roche

Samsung Bioepis has received European Commission approval for Ontruzant, its version of Roche’s best-selling breast cancer mAb Herceptin (trastuzumab).

Ontruzant was given a positive opinion in September​ by the European Medicines Agency (EMA) and has now been approved to treat various breast and gastric cancers.

The product, which will be sold by MSD (known as Merck & Co. in North America), is the first version of Roche’s Herceptin to be successful in Europe and the fourth monoclonal antibody biosimilar developed by Korea’s Samsung Bioepis to be approved in the region.

Benepali​ (etanercept), Flixabi​ (infliximab) and Imraldi​ (adalimumab) have all received EC marketing authorisation within the past two years. The firm's version of Sanofi's Lantus (insulin glargine), Lusduna, has also received approval.

“Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more cancer patients and healthcare systems across Europe will benefit from biosimilars,”​ Christopher Hansung Ko, Samsung Bioepis’ CEO, said in a statement.


The first biosimilar version of Roche’s Herceptin came in 2013​, when India gave the thumbs up to Mylan and Biocon’s Canmab. The molecule was given US Food and Drug Administartion (FDA) recommendation earlier this year​, but the approval has since been delayed.

Other developers of biosimilars include Amgen and Teva​, signalling further danger to Roche’s trastuzumab sales which in 2016 added CHF 6.8bn ($6.9bn) to the Swiss Biopharma’s topline.

But in a statement sent to Biopharma-Reporter, Roche said it views “biosimilar competition as a normal part of a biotherapeutic treatment’s life cycle and believes that biosimilars have a role to play in supporting the financial sustainability of healthcare systems.

“Herceptin providing a comprehensive dual blockade that is the current standard of care in first-line advanced breast cancer (aBC) and neoadjuvant early breast cancer (eBC). We have over 19 years’ experience manufacturing Herceptin and, during this time, it has been used to treat over two million patients.”

Related topics Markets & Regulations Biosimilars

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