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AbbVie, Novartis settle Humira biosimilar dispute for 2023 US launch

AbbVie Inc. has agreed to grant Novartis AG generic unit Sandoz a license to market a biosimilar of rheumatoid arthritis drug Humira beginning in 2023, marking an end to a patent lawsuit between the two pharmaceutical companies.

Under the terms of the agreement, Novartis will have a nonexclusive license to market its Humira copy, called Hyrimoz, in the U.S. starting in 2023. Novartis will pay undisclosed royalties to AbbVie for the license and all litigation between the two companies will be dismissed. AbbVie also permitted a European launch of the biosimilar for later in October. Hyrimoz is the third Humira biosimilar that has been granted permission to roll out in that year.

Biosimilars of branded drugs were introduced to the U.S. market with the implementation of the 2009 Biologics Price Competition and Innovation Act, which aimed to foster competition in the biologics market and lower drug prices. Biosimilars are to large, complicated biologics — often injectable or infused medicines derived from living cells — what generics are to small-molecule drugs. A number of legal disputes over patent infringement have popped up due to ambiguities in the new law, often leading to protracted legal disputes or settlements such as between AbbVie and Novartis.

AbbVie filed suit against Novartis in August over the Humira copy.

"We continue to believe biosimilars will play an important role in our healthcare system, but we also believe it is important to protect our investment in innovation," AbbVie Executive Vice President Laura Schumacher said in an Oct. 11 press release. "This agreement accomplishes both objectives."

Humira, a blockbuster rheumatoid arthritis drug, had sales of more than $12 billion in the U.S. in 2017, accounting for about two-thirds of North Chicago-based AbbVie's revenue. The three other U.S. Humira biosimilars have been developed by Amgen, Samsung Bioepis Co. Ltd. and Mylan AB. Novartis is allowed to launch at the end of September 2023, while Amgen can start selling in January, Samsung in June and Mylan in July.

Results from a late-stage clinical trial showed that Hyrimoz matched Humira's efficacy and safety. The U.S. Food and Drug Administration accepted Novartis' application in January. Novartis has already gained European Commission approval for the biosimilar, which was the fourth on the continent behind approvals for Amgen, Boehringer Ingelheim Auslandsbeteiligungs GmbH and Samsung.

"In order to realize the promise of early and expanded access and healthcare savings, biosimilars must be available as soon as possible to the patients and physicians who need them," said Stefan Hendriks, global head of biopharmaceuticals for Sandoz. "This settlement helps remove uncertainty regarding when our biosimilar adalimumab will be available and allows us to focus on expanding access for patients to the medicine they need to manage their chronic disease."

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