In July 2018, Pfizer received approval for its first therapeutic oncology biosimilar Trazimera by European Commission following recommendation from the Committee for Medicinal Products for Human Use (CHMP) in May 2018. Trazimera is a biosimilar to Herceptin (trastuzumab), approved for the treatment of human epidermal growth factor (HER2) positive breast cancer, gastroesophageal junction adenocarcinoma and HER2 positive metastatic gastric cancer. The approval allows the drug to be marketed in 28 member states of the European Union and European Economic Area. Pfizer is investing in development and launch of range of biosimilars in the European Union that would curb the healthcare expenditure and increase patient access to vital drugs. Trazimera is Pfizer’s fourth biosimilar to receive European approval and first oncology biosimilar. Strong pipeline of biosimilars in different stages of development would further strengthen Pfizer’s foothold in European region across different disease conditions. Pfizer has applied for U.S. Food and Drug Administration approval and awaiting approval in the U.S. for the biosimilar of traztuzumab.

Analyst View:

This approval of Pfizer’s first oncology biosimilar would assist the company to penetrate in the European oncology biosimilar market space. Presence of marketed oncology biosimilars by Sandoz, Amgen, Celltrion Healthcare would make the market highly competitive. High cost of biologics and patent expiry of blockbuster biologics by 2020 has surged the demand for biosimilars worldwide. Moreover, growing prevalence of cancer in Europe and globally would further boost the growth of oncology biosimilars giving access to significant medicines to patients and medical practitioners at a comparatively lower cost compared to patented biologics. Pfizer’s strong pipeline for biosimilars for various disease conditions and organized approval and regulatory scenario in the Europe would further drive the oncology biosimilars market in Europe in the coming period.