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.
You may also be interested in...
Mylan, Amgen Biosimilars Sail Through Advisory Panels, May Diverge From There
Mylan's Herceptin biosimilar faces questions on off-label use and manufacturing, while Amgen's Avastin biosimilar could be template for other products.
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.
US Biosimilars: 40% First-Cycle Approval Rate Leaves Room For Improvement
Four of first 10 publicly disclosed applications were approved on first review cycle, and FDA has issued at least seven complete response letters. Increasing first-cycle approvals is a primary goal of the BsUFA II agreement.