AbbVie, Samsung Bioepis in deal; Humira biosimilar U.S. release in 2023

(Reuters) - AbbVie Inc on Thursday said it signed a deal with Samsung Bioepis and its joint venture partner Biogen Inc that would fend off U.S. competition of their biosimilar version to blockbuster drug Humira until 2023.

This is the second deal AbbVie has signed over the past year as it tries to safeguard patents on Humira, which is the world’s top-selling prescription medicine.

The drug, which treats rheumatoid arthritis, raked in $18.43 billion in sales last year and accounted for nearly two-thirds of AbbVie’s net revenue.

While terms of the deal were undisclosed, AbbVie said it will make no payments to Samsung Bioepis and the three companies agreed to dismiss all pending lawsuits.

Even if multiple Humira biosimilars are delayed from market until 2023, this can be “more than offset” by a steeper sales decline for Humira, BMO Capital Markets analyst Alex Arfaei said.

Arfaei noted this is increasingly likely given the U.S. Food and Drug Administration’s encouraging stance on the approval of biosimilar drugs and fewer chances of drugmakers negotiating with insurers to gain preferred coverage of their drugs over rivals.

Samsung Bioepis’ license to market its biosimilar will kick off on June 30, 2023, after which Samsung will pay royalties to license Humira patents, AbbVie said in a statement.

Samsung Bioepis is partnered with Biogen to market the drug in Europe and Merck & Co to market it in the United States.

Biogen expects to launch the biosimilar, Imraldi, in Europe in mid-October this year.

In September, Amgen Inc reached a similar settlement with AbbVie to delay the U.S. launch of its cheaper biosimilar to Humira until Jan. 31, 2023.

Jefferies analyst Ian Hilliker notes the deal with Samsung Bioepis enables a biosimilar launch some months after Amgen, making it increasingly unlikely other rivals will be able to negotiate settlements that allow their launches before 2023.

Shares of AbbVie, which has been focusing on developing cancer drugs to sustain long-term growth, have been under pressure in recent months hurt by a failed trial of an experimental lung cancer treatment, Rova-T.

Reporting by Tamara Mathias in Bengaluru; Editing by Bernard Orr