Amgen, Allergan win first approval of cancer biosimilar in US
The FDA approved Amgen and Allergan’s biosimilar version of Roche’s Avastin, the first time they’ve approved a copycat biologic of a cancer drug. Amgen’s biosimilar, Mvasi, is cleared for use across five of Avastin’s approved indications. However, it was not approved as an interchangeable, so pharmacists can’t automatically switch patients from Avastin to Mvasi.
This approval highlights the competitive risk to Roche’s top-selling biologics: Herceptin, Avastin and Rituxan. A biosimilar of Rituxan made by Novartis recently won EU approval, and a copy of Herceptin secured the backing of the European Medicines Agency this week.
