Celltrion’s Herzuma® (trastuzumab biosimilar) receives EU approval
for early breast cancer, metastatic breast cancer, and metastatic
Inc. (KRX:068270) announced today that the European Commission (EC)
approved Herzuma® (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,
“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® and Truxima®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 agencies.”
The European Commission’s approval of Herzuma® marks an important
milestone for Celltrion, providing more treatment options for patients.
Herzuma® is the third biosimilar from Celltrion’s portfolio approved by
This decision by the European Commission means that Herzuma® is now
approved for marketing in the 28 member states of the European Union
(EU), in addition to Norway, Liechtenstein and Iceland.
Herzuma® is an anticancer monoclonal antibody (mAb) biosimilar drug used
to treat breast cancer and gastric cancer. Similarity of Herzuma® to the
reference product, Herceptin®2, was demonstrated in terms of
pharmacokinetic, pharmacodynamics, efficacy and safety through multiple
global clinical trials. In 2017, Celltrion launched Herzuma® 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® and Remsima®, 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®
(CT-P10, a mAb biosimilar to MabThera®3 (rituximab)) in
February 2017. For more information, visit www.celltrion.com.
1 Celltrion’s mAb products Remsima® (infliximab biosimilar)
and Truxima® (rituximab biosimilar) were approved by the EC in September
2013 and February 2017, respectively.
2 Herceptin® is a registered trademark of Genentech, Inc.
3 MabThera® is a registered trademark of F. Hoffmann-La Roche
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