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Celltrion's Herzuma(R) (trastuzumab biosimilar) receives EU approval for early
breast cancer, metastatic breast cancer, and metastatic gastric cancer
INCHEON, South Korea --(BUSINESS WIRE)--14.02.2018--
Celltrion, Inc. (KRX:068270) announced today that the European Commission (EC)
approved Herzuma(R) (trastuzumab biosimilar) for the treatment of patients with
early breast cancer, metastatic breast cancer, or metastatic gastric cancer
whose tumors have either HER2 overexpression or HER2 gene amplification. The
decision follows a positive opinion from the Committee for Medicinal Products
for Human Use (CHMP) on December 14, 2017.
'The development of biosimilar is of great importance in the field of oncology,
and has the potential to enrich our therapeutic arsenal against a variety of
diseases and to increase patients' accessibility to innovative drugs at a more
affordable price,' said Woosung Kee, Chief Executive Officer of Celltrion. 'We
have already seen many benefits of biosimilars in Europe from our experience
with Remsima(R) and Truxima(R)^1. 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
The European Commission's approval of Herzuma(R) marks an important milestone for
Celltrion, providing more treatment options for patients. Herzuma(R) is the third
biosimilar from Celltrion's portfolio approved by the EC.
This decision by the European Commission means that Herzuma(R) is now approved
for marketing in the 28 member states of the European Union (EU), in addition
to Norway, Liechtenstein and Iceland.
Herzuma(R) is an anticancer monoclonal antibody (mAb) biosimilar drug used to
treat breast cancer and gastric cancer. Similarity of Herzuma(R) to the reference
product, Herceptin(R)^2, was demonstrated in terms of pharmacokinetic,
pharmacodynamics, efficacy and safety through multiple global clinical trials.
In 2017, Celltrion launched Herzuma(R) in Korea.
About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical
company, specializing in research, development and manufacture of biosimilar
and innovative drugs. Celltrion strives to provide more affordable biosimilar
mAbs to patients who previously had limited access to advanced therapeutics.
Celltrion received FDA and EC's approval for Inflectra(R) and Remsima(R),
respectively, which is the world's first mAb biosimilar to receive approval
from a regulatory agency in a developed country. Celltrion also received EC's
approval for Truxima(R) (CT-P10, a mAb biosimilar to MabThera(R)^3 (rituximab)) in
February 2017. For more information, visit www.celltrion.com.
^1 Celltrion's mAb products Remsima(R) (infliximab biosimilar) and Truxima(R)
(rituximab biosimilar) were approved by the EC in September 2013 and February
^2 Herceptin(R) is a registered trademark of Genentech, Inc.
^3 MabThera(R) is a registered trademark of F. Hoffmann-La Roche AG.
View source version on businesswire.com: http://www.businesswire.com/news/home/
Gunn Lee, +82 32 850 5168
Heewon Park, +82 32 850 5356
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