Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement.
J&J has signed an agreement granting Alvotech and Teva a license for their proposed Stelara biosimilar, AVT04, in the U.S. The settlement allows the biosimilar makers to launch their version no later than Feb. 21, 2025, the companies said Monday.
The new Stelara biosim deal follows another one J&J recently inked with Amgen, which gives the latter a license to launch its copycat no later than Jan. 1, 2025.
Like Amgen, Alvotech and Teva haven’t gotten the FDA’s blessing for AVT04. The pair in January said the FDA had accepted its application with a decision targeted for the second half of this year. A verdict for Amgen’s version is expected by the end of the third quarter.
Settling those biosimilar entry dates is important for J&J. With $9.7 billion sales in 2022, Stelara has been J&J’s top-selling drug, accounting for 10% of the pharma giant’s entire revenue base. About $6.4 billion of the haul came from the U.S.
The IL-12/23 inhibitor is approved in a range of inflammatory diseases including psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The drug has a U.S. composition of matter patent that will expire in September.
Other companies developing Stelara biosimilars include Samsung Bioepis, Celltrion, Biocon and a partnership between Bio-Thera and Hikma.
Teva linked up with Alvotech on AVT04 in 2020 as part of a strategic partnership that covers five biosimilar candidates in the U.S. While Alvotech takes care of development, regulatory and manufacturing, Teva is responsible for commercialization.
Alvotech hasn’t exactly been the most reliable drug manufacturer, though. In April, the Icelandic firm said it had received a second complete response letter from the FDA regarding its application for AVT02, a high-concentration biosimilar to AbbVie’s Humira.
The agency spurned Alvotech after a reinspection of the company’s Reykjavik facility in Iceland again found certain deficiencies. That application remains under review with a goal date of June 28, according to the company.
AVT02 also belongs to Alvotech’s alliance with Teva, along with AVT05 (a biosimilar to J&J’s anti-TNF agent Simponi), AVT06 (a biosimilar to Regeneron’s eye med Eylea) and AVT16, which copies an undisclosed immunology product.
For Teva, biosimilars are a key element in new CEO Richard Francis’ return-to-growth plan. Besides neuroscience drugs Austedo and Uzedy, Teva counts seven biosimilar candidates in late-stage development as potential revenue drivers in the short term.