SILVER SPRING
AVT80 BLA accepted for review
- Sponsor
- Alvotech
- Drug
- adalimumab
FDA accepted Alvotech's BLA for AVT80, a proposed biosimilar to adalimumab.
What this means
AVT80 is a proposed copy of the antibody drug Humira, which works by blocking an inflammatory protein called TNF. Today the FDA formally accepted Alvotech's application to market AVT80, starting its review process. This step could pave the way for a new competitor in the market for treating conditions like rheumatoid arthritis and Crohn's disease.
Drug Watch — recent news on adalimumab
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