Samsung Bioepis received first positive CHMP opinion on a trastuzumab biosimilar

September 18, 2017 10:09 AM

Samsung Bioepis Co., Ltd.announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Ontruzant, a biosimilar candidate referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

The CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide on the grant of a marketing authorization for Ontruzant. If a marketing authorization is granted by the EC, Ontruzant will be commercialized in the European Union by MSD, which is known as Merck in the United States and Canada.

“We are proud to see Ontruzant become the first trastuzumab biosimilar recommended for approval in Europe, where breast cancer remains the most common form of cancer affecting women. If approved, 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.”

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)


Latest News on Biosimilar News

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?

Suggestions?

Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!