The U.S. FDA has rejected Alvotech's application to market a biosimilar version of J&J's arthritis therapy, Stelara, with the biotech's Reykjavik facility again to blame.
The biosimiliar specialist appears to have seen it coming, stating in a press release that "as expected" the CRL for its AVT04 application cited deficiencies, conveyed following the FDA’s March 2023 inspection of the company’s Reykjavik facility, that must be resolved before the application can be approved.
Beyond the facility issues, Alvotech says no other deficiencies in the application were noted by the FDA. The company intends to resubmit the BLA for AVT04 to the FDA shortly, which it expects will trigger a six-month review period and a new BsUFA goal date.
Alvotech, along with partner Teva, reached a settlement and license agreement with J&J back in June 2023, securing an entry date for AVT04 in the U.S. no later than February 21, 2025.
This is not the first time the facility has foiled Alvotech's plans. The Alvotech-Teva Humira biosimilar, AVT02, was thrice rejected due to issues at the plant. The first time came in September 2022, following a 483 from a March inspection. The 483 listed 13 observations, including mold and microbial excursions, as well as issues with the sterility of stoppers used in packaging.
Two more CRLs for AVT02 followed, one this past April and another one in June, all attributed to the facility.
