Initial results of the phase 3 Herceptin trial, which began dosing patients last October, are expected toward the end of 2011, at which time Roche could seek marketing approval. “We can rely on ...

The FDA has approved Amgen and Allergan’s biosimilar of Roche’s Herceptin, just in time for the breast cancer blockbuster’s patent expiry. Herceptin’s main US patent expires this month ...

Roche has had time to defend Herceptin against biosimilars, however. A patent-protected subcutaneous formulation of the drug was launched some years ago, and now represents 50% or more of the market.