January 19, 2019

Celltrion’s Herceptin biosimilar wins EU nod

PUBLISHED : February 14, 2018 - 14:46

UPDATED : February 14, 2018 - 15:00

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[THE INVESTOR] Celltrion said on Feb. 14 that it has got approval to sell its copy version of Roche’s breast cancer med Herceptin in Europe.

The European Commission granted marketing authorization for Herzuma developed by Celltrion for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

Herzuma is Celltrion’s third biosimilar that will hit the European market, following its version of Johnson & Johnson’s Remicade called Remsima, and Truxima -- knockoff of Roche’s Rituxan,

The approval for Herzuma comes three months after Celltrion’s crosstown rival Samsung Bioepis received regulatory approval for Europe’s first Herceptin biosimilar Ontruzant in November.

The two companies expect to launch their products in the first half of 2018.

Europe is an important market for Celltrion as it accounts for some 80 percent of its total biosimilar sales as European countries increase uptake of the lower-cost copy versions to reduce health care spending. Discounts of biosimilars are around 30 percent on average in Europe.

“We have already seen many benefits of biosimilars in Europe from our experience with Remsima and Truxima. Our experience has shown that biosimilars not only reduce individual patient’s out-of-pocket medical expenses but also contribute to lowering financial burden on insurance payers and national health agencies,” said Woosung Kee, CEO of Celltrion.

With the upcoming launch, Celltrion is seeking to eat into the original drug’s European market share which is valued at some 2.45 trillion won (US$2.26 billion).

The approval enables Celltrion to sell Herzuma in all the 28 European Union member states as well as Norway, Iceland and Liechtenstein, the firm said. In the US, Herzuma’s approval is being reviewed by the Food and Drug Administration.

By Park Han-na (

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