EMA to Review Samsung Bioepis’ Herceptin Biosimilar
The European Medicines Agency (EMA) has accepted for review a marketing authorization application from Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, for SB3, a biosimilar candidate referencing Herceptin (trastuzumab), Roche’s monoclonal antibody indicated for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. The application for SB3 was submitted in August 2016. Herceptin is one of Roche’s leading products with global 2015 sales of CHF 6.5 billion ($6.7 billion).
SB3 is Samsung Bioepis’ fifth biosimilar candidate submitted to the EMA, following SB4, a biosimilar to Amgen’s Enbrel (etanercept); SB2, a biosimilar to Johnson & Johnson’s Remicade (infliximab); SB9 a biosimilar to Sanofi’s Lantus (insulin glargine); and SB5, a biosimilar to AbbVie’s Humira (adalimumab). SB4 and SB2 have since received regulatory approval from the European Commission.
SB3 is the company’s first oncology biosimilar candidate submitted for regulatory review in Europe, according to Samsung Bioepis. If approved, the marketing and distribution for it in Europe will be handled by Merck & Co.
Source: Samsung Bioepsis