Biosimilarity Margin Change By FDA Might Give Amgen's Avastin Copy Big Head Start
Did Amgen/Allergan get a lucky break by already having their clinical trial enrolled and being unable to increase the sample size for their Avastin biosimilar?
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Mylan's Herceptin Advisory Committee May Be First Bumpy One For A Biosimilar
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Amgen's Avastin Biosimilar May Revive Orphan Indication Concerns
Questions about US FDA's handling of orphan indications may arise again during upcoming Oncologic Drugs Advisory Committee meeting on ABP215, a proposed Avastin biosimilar.