Ref: Business Wire
- ONTRUZANT® is the
industry's first biosimilar referencing Herceptin® i (trastuzumab)
to receive marketing authorization from the European Commission
- 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.
This press release features
multimedia. View the full release here: http://www.businesswire.com/news/home/20171119005066/en/
Christopher Hansung Ko,
President & CEO of Samsung Bioepis. (Photo: Business Wire)
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® (adalimumab).
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: www.samsungbioepis.com.
iHerceptin® is
a registered trademark of Genentech Inc.
View source version on
businesswire.com: http://www.businesswire.com/news/home/20171119005066/en/
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