Amgen, Abbvie settlement sets stage for Humira biosimilar launch in 2023

THOUSAND OAKS, Calif. — Humira manufacturer AbbVie and Amgen, maker of Humira biosimilar Amjevita (sometimes spelled Amgevita), have reached a settlement that will allow the biosimilar to launch — but not for several years. The settlement will see AbbVie granting Amgen a non-exclusive license to its Humira intellectual property on certain dates in certain countries, with the license period set to begin on Jan. 31, 2023.

Also under the agreement, Amgen will pay undisclosed royalties to AbbVie. As a result of the settlement, all litigation between the two companies has been dismissed, with Amgen acknowledging the validity of AbbVie’s intellectual property relating to Humira.

“We look forward to leveraging our existing biologics capabilities to bring high-quality biosimilars to patients worldwide. Amgevita will be one of our first biosimilar launches, and this agreement will allow us to secure a strong foothold in the $4 billion European adalimumab market," Amgen VP and GM biosimilars Scott Foraker said “Building on our strong inflammatory disease presence in the United States, we are excited to develop our inflammation capabilities in Europe, extending our reach and helping more patients gain access to this important class of therapies.”

AbbVie EVP external affairs, general counsel and corporate secretary Laura Schumacher said, “We are pleased to have reached this settlement with Amgen which respects the breadth and strength of our intellectual property portfolio. … In reaching this agreement, we have achieved the balance between protecting investment in innovation and providing access to biosimilars, which will play an important role in our health care system. We will continue to defend our intellectual property and to reinvest in further advancements in medicine to bring choices to patients in need.”