How Risky Is Amgen's At-Risk Launch Of Herceptin, Avastin Biosimilars?
In ongoing patent litigation with Genentech, Amgen may need to reveal its counsel's advice on whether it should launch, while Genentech must produce its settlement agreements with Mylan, Celltrion, and Pfizer.
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Amgen and Allergan have announced positive top-line results from a pivotal clinical study of their rituximab biosimilar version of Roche’s blockbuster biologic Rituxan to treat patients with non-Hodgkin's lymphoma.
Amgen/Allergan's Kanjinti had second longest development time among five licensed biosimilars to Genentech's Herceptin but was the first to reach market, according to a Pink Sheet timeline of development and regulatory milestones for the follow-on products.
Mylan-Biocon’s biosimilar Herceptin debuts in Australia, promising to provide patients a high quality and affordable alternative, though at least three competing trastuzumab versions including Amgen’s Kanjinti are in the wings.