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www.fdanews.com/articles/173305-amgen-allergan-claim-biosimilar-is-clinically-equivalent-to-avastin

Amgen, Allergan Claim Biosimilar is Clinically Equivalent to Avastin

September 29, 2015

Amgen and Allergan claim their biosimilar candidate is clinically equivalent to Roche’s blockbuster Avastin in adult patients with advanced non-small cell lung cancer.

The companies announced results of a Phase 3 study involving 642 patients showed ABP 215 is comparable to Avastin (bevacizumab) for safety. They have not filed a BLA with the FDA, and have not disclosed filing dates, spokeswoman Kristen Davis said.  

In December 2011, Amgen and Allergan (then known as Watson) formed a collaboration to develop and commercialize on a worldwide basis four oncology antibody biosimilar medicines. — Jonathon Shacat