Samsung Bioepis’ Marketing Authorization Application for trastuzumab biosimilar accepted for review by EMA

October 7, 2016 8:35 AM

SB3, a biosimilar candidate referencing Herceptin (trastuzumab), is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in Europe.

Samsung Bioepis Co., Ltd. this week announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB3, a biosimilar candidate referencing Herceptin (trastuzumab).

Herceptin is a monoclonal antibody (mAb) indicated for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. The MAA for SB3 was submitted in August 2016.

“Trastuzumab remains vital in treating breast cancer, the most prevalent form of cancer affecting women across Europe,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “If approved, we hope our affordable, high-quality medicine will help realize the promise of biosimilars for breast cancer patients across Europe by widening patient access to this important, life-enhancing treatment option.”

SB3 is Samsung Bioepis’ fifth biosimilar candidate submitted to the EMA, following SB4 (etanercept), SB2 (infliximab), SB9 (insulin glargine) and SB5 (adalimumab). SB4 and SB2 have since received regulatory approval from the European Commission (EC). SB3 is also the company’s first oncology biosimilar candidate submitted for regulatory review in Europe. If approved, the marketing and distribution of SB3 in Europe will be handled by Merck, which is known as MSD outside of the United States and Canada.


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