EC approves Pfizer's Herceptin biosimilar
Pfizer's Herceptin (trastuzumab) biosimlar Trazimera has been approved by the European Comission.
Trazimera is the company's first oncology biosimilar and fourth biosimilar overall to receive European approval. Like its originator it will be licesnced to treat human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
“Trazimera has the potential to help many patients with HER2 overexpressing cancers, such as breast and gastric, which can correlate with poor outcomes and aggressive disease,” said Professor Diana Lüftner, Charité Campus Benjamin Franklin and Member of the Presidency of the German Society of Hematology and Medical Oncology. “Today’s approval will help enable greater access for patients and physicians across Europe, without compromising on quality, efficacy and safety.”
The EC approval is based on data that included results from the REFLECTIONS B327-02 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Trazimera and originator product in patients with first line HER2 overexpressing metastatic breast cancer.
Herceptin was developed by Genentech and was the 5th best-selling drug globally in 2017 with sales worth €5.9 billion.
31st July 2018http://www.pharmatimes.com/