European Medicines Agency accepts for review the MAA for SB3, a trastuzumab biosimilar, to treat early breast cancer, metastatic breast cancer and metastatic gastric cancer.- Samsung Bioepis + Merck Inc.
Samsung Bioepis Co., Ltd. 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. 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 Inc., which is known as MSD outside of the United States and Canada.
Comment:The primary patent on Herceptin expired on 28 July 2014 in the EU and will expire in the US in January 2019.
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