Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab)
Portfolio Pulse from
Alvotech and Teva Pharmaceuticals have announced the FDA's acceptance of Biologics License Applications for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®. This marks the first U.S. BLA filing acceptance for a biosimilar candidate to golimumab, with the FDA review expected to conclude in Q4 2025.
January 27, 2025 | 11:15 am
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Alvotech's BLA for AVT05, a biosimilar to Simponi®, has been accepted by the FDA, marking a significant milestone for the company in the U.S. market.
The acceptance of the BLA by the FDA is a crucial step for Alvotech, potentially opening up the U.S. market for their biosimilar product. This could lead to increased revenue and market presence.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Teva Pharmaceuticals, in partnership with Alvotech, has achieved FDA acceptance for the BLA of AVT05, a biosimilar to Simponi®, enhancing its biosimilar portfolio.
Teva's collaboration with Alvotech and the FDA's acceptance of the BLA could strengthen its position in the biosimilar market, potentially boosting its product offerings and market share.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 70