In November 2017, the European Medicines Agency’s (or EMA) Committee for Medicinal Products for Human Use (or CHMP) recommended a positive opinion for the marketing authorization of Amgen’s (AMGN) and Allergan’s (AGN) ABP 215. ABP 215 is a biosimilar to Roche’s (RHHBY) Avastin (bevacizumab).
Recommendations for ABP 215
Amgen and Allergan’s ABP 215 has been recommended in combination with certain drugs for approval for some cancer types as follows:
- metastatic carcinoma of the colon or rectum
- metastatic breast cancer
- unresectable advanced, metastatic, or recurrent non-squamous non-small cell lung cancer
- platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
- persistent, recurrent, or metastatic carcinoma of the cervix
The European Commission expects to review the CHMP recommendation. The European Commission’s marketing authorization approval would allow Amgen to commercialize its biosimilar in 28 European Union member countries.
In September 2017, the FDA approved ABP 215 for commercialization in the US under the brand name Mvasi. Amgen is conducting a Phase 3 trial with ABP 710 and ABP 798, which are biosimilars to Johnson & Johnson’s (JNJ) Remicade and Roche’s Rituxan.
Amgen holds ten biosimilars in its portfolio, one of which has been approved by the European Commission.
In 1Q17, 2Q17, and 3Q17, Roche generated revenues of ~1.7 billion Swiss francs, ~1.7 billion Swiss francs, and ~1.6 billion Swiss francs, respectively, from the sales of Avastin.
Amgen constitutes ~4.1% of the Health Care Select Sector SPDR ETF (XLV).