NasdaqGM:ALVOBiotechs
How Do Alvotech's (ALVO) FDA Resubmissions Reframe Its U.S. Biosimilar Ambitions?
Alvotech recently resubmitted Biologics License Applications to the U.S. FDA for AVT05, a proposed biosimilar to Simponi and Simponi Aria, and AVT06, a proposed biosimilar to Eylea 2 mg, after addressing manufacturing and quality concerns at its Reykjavik facility and responding to a recent cGMP surveillance inspection.
The move, under its commercialization partnership with Teva, underscores Alvotech’s push to expand its U.S. biosimilar footprint while reinforcing upgraded quality systems...