Sean E. Harper, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the bevacizumab (Avastin) biosimilar ABP 215 for the treatment of patients across several tumor types.
The positive opinion will now be reviewed by the European Commission. If approved, the biosimilar would be authorized for the following indications:
- Metastatic carcinoma of the colon or rectum, in combination with fluoropyrimidine-based chemotherapy;
- Metastatic breast cancer, in combination with paclitaxel;
- Unresectable advanced, metastatic or recurrent non-squamous non–small cell lung cancer (NSCLC), in combination with platinum-based chemotherapy;
- Unresectable advanced, metastatic or recurrent nonsquamous NSCLC, in combination with erlotinib;
- Advanced and/or metastatic renal cell cancer, in combination with interferon alfa-2a;
- Advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin
- Persistent, recurrent, or metastatic carcinoma of the cervix, in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan.
“ABP 215 has the potential to provide healthcare professionals and appropriate patients across Europe access to high-quality, targeted cancer therapy,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, which co-develops ABP 215 with Allergan, said in a statement. "The positive CHMP opinion for ABP 215 marks the first time a bevacizumab biosimilar has been recommended for approval in the European Union, which is an exciting milestone for Amgen."
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