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Samsung Bioepis receives positive opinion for Herceptin biosimilar
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Samsung Bioepis received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Ontruzant, a biosimilar candidate to Genentech’s Herceptin, or trastuzumab, for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer, according to a press release.
After receiving information about the positive opinion offered by the Committee for Medicinal Products for Human Use (CHMP), the European Commission (EU) will decide on the grant of a marketing authorization for Ontruzant, according to the release. If the EU grants Ontruzant marketing authorization, Merck will commercialize the candidate in the European Union, per the release.
“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,” Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in the release. “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 health care systems across Europe will benefit from biosimilars.”
Disclosure: Ko is president and CEO of Samsung Bioepis.