Pfizer's Avastin Biosimilar Wins FDA Approval

By Reuters Staff

July 02, 2019

(Reuters) - Pfizer Inc said on Friday that the U.S. Food and Drug Administration had approved its biosimilar to Roche Holding AG's blockbuster cancer treatment Avastin (bevacizumab).

Pfizer's Zirabev received approval for the treatment of five types of cancer, including colorectal and lung cancers, it said.

In 2017, U.S.-based Amgen Inc's Mvasi was approved by the FDA as the first biosimilar to Roche's Avastin, which brought in revenue of $6.85 billion to the Swiss drugmaker in 2018.

Roche has been facing declining sales for its three leading cancer drugs - Avastin, Herceptin (trastuzumab), Rituxan (rituximab) - due to severe competition in Europe from low-cost versions called biosimilars.

Earlier this year, Pfizer won European approval for Zirabev, months after the treatment gained a positive recommendation from the Committee for Medicinal Products for Human Use.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....