The approval of Zirabev (bevacizumab) follows the positive opinion given to the biosimilar in December 2018, by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP).
Avastin is a blockbuster product for Roche, with global sales of CHF6.84bn (€5.71bn), and has been targeted by biosimilar producers, alongside other products in the Swiss company’s portfolio.
Herceptin (trastuzumab) and MabThera/Rituxan (rituximab) are also facing a number of biosimilar competitors across markets.
Roche’s CEO had previously warned that biosimilar competition would emerge to these products during the course of 2019.
When Pfizer will release Zirabev in Europe is not clear; Amgen and Allergan’s biosimilar, Mvasi, became the first approved biosimilar to Avastin in Europe in January 2018 but has not yet reached the European market. Patent protection on Avastin in Europe continues until 2022 unless legally challenged.
When asked about potential launch dates for Zirabev, a spokesperson told us, “Pfizer is working to make Zirabev available to patients in Europe as early as possible. We are unable to provide more information at this time.”