Celltrion Receives EU Approval for Trastuzumab Biosimilar
February 13 2018 - 08:32PM
Business Wire
Celltrion’s Herzuma® (trastuzumab biosimilar) receives EU
approval for early breast cancer, metastatic breast cancer, and
metastatic gastric cancer
Celltrion, 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, 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® 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 the EC.
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.
About Herzuma®
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
AG.
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Celltrion, Inc.Gunn Lee, +82 32 850
5168Gunhyuk.lee@celltrion.comorHeewon Park, +82 32 850
5356Heewon.park@celltrion.com