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?
You may also be interested in...
Mylan's Herceptin biosimilar faces questions on off-label use and manufacturing, while Amgen's Avastin biosimilar could be template for other products.
US FDA did not address production problems in its briefing document for upcoming Oncologic Drugs Advisory Committee meeting, but manufacturing deficiencies found at Biocon's facility could prompt questions.
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.