Pfizer secures European approval for Avastin biosimilar

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Dmitrii Balabanov)
(Image: Getty/Dmitrii Balabanov)

Related tags: Pfizer, Roche, Avastin, Zirabev

Pfizer’s Zirabev receives approval from the European Commission as a biosimilar to Roche’s Avastin, which brought in sales of CHF1.8bn in Europe during 2018.

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.”

Related topics: Markets & Regulations, Biosimilars

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