Samsung Bioepis Receives Regulatory Approval for Europe’s First Trastuzumab Biosimilar, ONTRUZANT®

  • ONTRUZANT® is the
    industry’s first biosimilar referencing Herceptin
    ® i
    (trastuzumab) to receive marketing authorization from the European
  • Samsung Bioepis sets an industry record by obtaining European
    regulatory approval for four biosimilars in just two years

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC)
marketing authorization of ONTRUZANT®, a biosimilar
referencing Herceptin® (trastuzumab), for the
treatment of early breast cancer, metastatic breast cancer and
metastatic gastric cancer. ONTRUZANT® is the first
trastuzumab biosimilar to receive regulatory approval in Europe.

The EC approval of ONTRUZANT® applies to all 28
European Union (EU) member states and the European Economic Area (EEA)
member states of Norway, Iceland and Liechtenstein. ONTRUZANT® will
be commercialized by MSD, which is known as Merck in the United States
and Canada.

“Breast cancer remains the most common form of cancer affecting women.
We hope ONTRUZANT will play an important role expanding patient access
to trastuzumab across the region,” said Christopher Hansung Ko,
President & CEO of Samsung Bioepis. “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.”

ONTRUZANT® is the fourth biosimilar developed by
Samsung Bioepis to receive EC marketing authorization. Samsung Bioepis
has also received marketing authorizations for Benepali®
(etanercept), Flixabi® (infliximab) and Imraldi®

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company
committed to realizing healthcare that is accessible to everyone.
Through innovations in product development and a firm commitment to
quality, Samsung Bioepis aims to become the world’s leading
biopharmaceutical company. Samsung Bioepis continues to advance a broad
pipeline of biosimilar candidates that includes six first-wave
candidates that cover the therapeutic areas of immunology, oncology and
diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics
and Biogen. For more information, please visit:

iHerceptin® is a registered
trademark of Genentech Inc.


Samsung Bioepis Co., Ltd.
Mingi Hyun