Humira Litigation Comes to a Close, Clearing Path to Biosimilar Launch

Today, AbbVie announced a global resolution of intellectual property-related litigation with Amgen over a proposed biosimilar for adalimumab (Humira), according to a press release.

"We are pleased to have reached this settlement with Amgen which respects the breadth and strength of our intellectual property portfolio," said Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary, AbbVie.

Under the settlement, AbbVie will grant Amgen a non-exclusive license to adalimumab beginning on January 31, 2023 in the United States and on October 16, 2018, in several other countries.

The agreement requires Amgen to pay royalties to AbbVie for sales of the biosimilar, according to the release.

The company alleged that Amgen infringed on 61 adalimumab patents, but they only included 10 in the lawsuit that was brought before the biosimilar was approved.

AbbVie reports that the exact terms of agreement are confidential, but all pending litigation has been dropped, with Amgen acknowledging the validity of the claims.

"As an innovation driven bio-pharmaceutical company, we believe intellectual property is essential to protect the investment in science and advance novel cures for the toughest health challenges,” Schumacher said in the release. “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."

According to a press release from Amgen, the manufacturer expects that their biosimilar, adalimumab-atto (Amgevita/Amjevita), will be launching in Europe and in the United States on the aforementioned dates.

"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," said Scott Foraker, vice president and general manager of Biosimilars at Amgen. "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."