Amgen Inc.'s proposed biosimilar to Roche's Avastin (bevacizumab) and Mylan NV's proposed biosimilar to Roche's Herceptin (trastuzumab) appear set to sail through the US FDA's Oncologic Drugs Advisory Committee, as the panel is devoting just half a day to each biologics license application.
Biosimilars For Avastin, Herceptin To Cap Off Busy July For ODAC
Pfizer's Mylotarg attempt to return to US market is first up for FDA's Oncologic Drugs Advisory Committee, followed by Novartis's CAR-T therapy. ODAC will then give half-day review to Amgen's and Mylan's biosimilars, suggesting FDA is increasingly comfortable with the product category.
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