Samsung Bioepis Co., a joint venture between South Korea’s Samsung BioLogics Co. and U.S.-based Biogen Inc., has won the European Commission`s marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), beating out rivals in the race for a first-mover position.

Celltrion, another Korean biosimilar developer, and U.S. firms Amgen and Allergan are still awaiting the OK from the EC of their Herceptin biosimilars after submission in October of last year and March of this year, respectively.

On Monday, Samsung Bioepis announced the EC’s approval of Ontruzant for the treatment of primary and metastatic breast cancer and metastatic gastric cancer.

With the EC’s marketing authorization of the biosimilar, Samsung Bioepis becomes the industry’s first to European approval for Herceptin biosimilar and the largest holder of biosimilars whose originator drugs belonging to the top 10 blockbuster drugs worldwide.

Herceptin generated global sales of nearly $7 billion in 2016 for Roche. It was the eighth best-selling drug in the world.

Samsung Bioepis expects to have the upper hand in marketing competition with the latest approval, but it has yet to determine the exact launching date.

By Shin Chan-ok and Minu Kim

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