Alvotech Reaches Settlement with J&J Over Stelara Biosimilar

Case files with gavel and scale

Pictured: Desk with case files, gavel and scales of justice/iStock, lakshmiprasad S

Iceland-based Alvotech, which is developing several biosimilars,  has reached a settlement with a biosimilar for Johnson & Johnson’s blockbuster arthritis drug Stelara (ustekinumab), the biotech announced Thursday.

Alvotech said the agreement involves J&J in Canada, the European Economic Area, and Japan for the Stelara biosimilar known as AVT04. It comes as the AVT04 biosimilar had been given marketing approval in Japan late last year.

Further details of the settlement were not disclosed.

“We look forward to working with our commercial partners in launching the first biosimilar to Stelara in these global markets, thereby increasing patient access to a vital biologic,” Alvotech CEO Robert Wessman said in a statement. 

Alvotech said AVT04 is expected to enter the Canadian market sometime in the first quarter of 2024. The Japanese launch is estimated to start in May 2024 after the National Health Insurance reimbursement price listings are posted. For Europe, Alvotech expects to enter “as soon as possible” after the European Supplementary Protection Certificate expiration date for the drug, which runs out in July 2024. 

Despite the settlement, Alvotech has been facing hurdles from U.S. regulators to get the biosimilar over the line in this country. In October 2023, the FDA refused to approve AVT04, handing down a fourth rejection to the company. The agency’s complete response letter identified “deficiencies” at Alvotech’s Reykjavik manufacturing site in an inspection in March 2023.

According to the FDA’s inspection report, 13 significant observations were noted by inspectors, with high levels of mold, defective stoppers and quality control of raw materials, among some of the major issues.

In June 2023, Alvotech and its AVT04 commercial partner Teva reached a settlement and license agreement with J&J that gave AVT04 a U.S. entry date of no later than Feb. 21, 2025, pending FDA approval.

As the patent for Stelara expired last year, J&J has been making deals to delay the launch of biosimilars. Amgen and J&J came to an agreement for the California-based pharm to not launch until 2025, and keep adding to J&J’s coffers but biosimilars in Europe are still on track for release this year.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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