European regulators have agreed to review Samsung Bioepis' application to market SB3, a biosimilar of Roche's cancer drug Herceptin.
Herceptin is a monoclonal antibody indicated for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.
SB3 is Samsung Bioepis' fifth biosimilar candidate submitted to the European Medicines Agency, following SB4 (etanercept), SB2 (infliximab), SB9 (insulin glargine) and SB5 (adalimumab).
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 US and Canada.
Herceptin pulled in sales of around $3.5 billion for Roche in the first-half of this year.