FDA Clears Second Alvotech Plant for Humira Biosimilar SIMLANDI
Alvotech wins FDA approval to expand U.S. manufacturing capacity for SIMLANDI, its biosimilar to AbbVie's Humira, across two Reykjavik facilities.
The U.S. Food and Drug Administration has approved additional domestic manufacturing capacity for SIMLANDI, Alvotech's biosimilar version of AbbVie's blockbuster immunology drug Humira, the Icelandic biotechnology company announced. The decision allows the AVT02 drug substance used in SIMLANDI to be produced in either of Alvotech's two drug substance suites located in Reykjavik, Iceland.
The regulatory clearance is significant for supply-chain resilience, giving Alvotech redundant production capability should one facility face operational disruptions. Dual-suite authorization is a strategic advantage in the biosimilar market, where manufacturing reliability can be a key differentiator as multiple adalimumab biosimilars compete for formulary placement across U.S. health systems and pharmacy benefit managers.
Read more Reap and Collinson Link Crypto Cards to Priority Pass Lounges →
Humira, AbbVie's flagship product, has historically been among the top-selling prescription drugs globally, generating tens of billions in annual revenue before its U.S. patent exclusivity eroded. The arrival of biosimilar competition, including SIMLANDI, has intensified pressure on drug pricing in the high-cost immunology segment, with payers and employers increasingly seeking lower-cost alternatives.
Alvotech's expanded manufacturing authorization underscores a broader industry trend of biosimilar makers investing in production infrastructure to secure long-term contracts and satisfy FDA's stringent quality standards. Approval of a second manufacturing suite typically requires a supplemental biologics license application review, reflecting the agency's thorough oversight of biosimilar production changes.
Continue reading at GlobeNewswire - Industry News on Financial Services.
