Amgen's Avastin Biosimilar May Revive Orphan Indication Concerns
Executive Summary
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.
You may also be interested in...
Biosimilar User Fees Discounted To Begin Second Round
After adjusting for expected workload, US FDA reduces biosimilar user fee revenue target, which lowered application fees.
Biosimilar User Fees Discounted To Begin Second Round
After adjusting for expected workload, US FDA reduces biosimilar user fee revenue target, which lowered application fees.
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?