The European Medicines Agency (EMA)’s committee for medicinal products for human use (CHMP) has recommended marketing authorisation of Pfizer’s Zirabev (bevacizumab).
Zirabev is a potential biosimilar to Roche’s best-selling cancer drug, Avastin. In 2017 alone, Roche reported global Avastin sales of CHF 6.68bn ($6.7m), including CHF 1.77bn from Europe.
The European Commission (EC) will now review the CHMP’s positive opinion before making a final decision. “Pfizer cannot speculate on the outcome and expects a final decision will be delivered in next several months,” a company spokesperson told us.
While Pfizer did not disclose specific pricing or commercialisation strategies for Zirabev. However, the spokesperson told us it “hopes that patients and their physicians will have improved access to a high-quality, potentially lower-cost alternative bevacizumab treatment option for the treatment of [certain cancers, including] metastatic carcinoma of the colon or rectum, [and] metastatic breast cancer."
If successful, Zirabev will also compete with Amgen’s Mvasi (bevacizumab) for market share; the latter received European approval in January, 2018.
The recommendation marks Pfizer’s second in biosimilar oncology this year, following the CHMP’s review of Trazimera – a biosimilar to Roche’s Herceptin (trastuzumab) – in June. Trazimera received European approval the following month.
In the US, Roche is similarly preparing to face biosimilar competition, as Avastin’s patent protection approaches expiry. Although not yet on the market, Mvasi received US Food and Drug Administration approval in September 2017.
Launch dates are yet to be disclosed, however earlier this year, Roche predicted an Avastin biosimilar would enter the US market in the second half of 2019.