Another mAb Biosimilar on the Horizon in Europe

Pfizer gests positive opinion for trastuzumab from Europe’s Committee for Medicinal Products for Human Use

Herceptin® (trastuzumab) is a monoclonal antibody developed by Genentech (and marketed by owner Roche) for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has or has not spread into the lymph nodes, metastatic breast cancer and gastric cancer. Herceptin is often used with other chemotherapy agents but can also be used alone after treatment with of therapies has been completed. 

Patent protection for Herceptin has expired. In the US, only one trastuzumab biosimilar has been approved to date - MYL-1401O (Ogivri; trastuzumab-dkst), which was co-developed by Mylan and Biocon. FDA accepted a biologics license application (BLA) for biosimilar trastuzumab candidate SB3 from Samsung Bioepis and co-development partner Merck in December 2017. In May 2018, Pfizer received a complete response letter from FDA regarding its biologics license application (BLA) for a trastuzumab biosimilar in which the agency request additional technical information. 

In Europe, Samsung Bioepsis received the first approval for a Herceptin biosimilar, which its marketing partner Merck & Co (MSD in Europe) is selling under the name Ontruzant. Celltrion’s Herceptin biosimilar Herzuma received European approval in January 2018 and is being marketed in Europe by Mundipharma beginning in May 2018.

Most recently, Pfizer received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its trastuzumab biosimilar TRAZIMERA™. The committee recommended marketing authorization for the treatment of HER2 overexpressing breast cancer and HER2 over-expressing metastatic gastric or gastroesophageal junction adenocarcinoma.


Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications