Amgen, AbbVie settlement over Humira biosimilar

Amgen said it reached a global settlement with AbbVie to resolve all pending litigation regarding Amgevita/Amjevita, a biosimilar to AbbVie’s blockbuster rheumatoid arthritis drug Humira (adalimumab).

Humira is by far the world’s top-selling prescription medicine with second-quarter sales of $4.7 billion, putting it on track for annual sales exceeding $18 billion, according to Reuters.

Under terms of the agreement, AbbVie will grant patent licenses for the use and sale of Amgevita/Amjevita worldwide, on a country-by-country basis, and the companies have agreed to dismiss all pending litigation.

Amgen said it expects to launch Amgevita in Europe on October 16, 2018, and Amjevita in the United States on January 31, 2023.

“We look forward to leveraging our existing biologics capabilities to bring high-quality biosimilars to patients worldwide,” said Scott Foraker, vice president and general manager of Biosimilars at Amgen.

“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.

“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.”

Specific financial terms of the agreement were not disclosed.

In a statement, AbbVie said: “Amgen will pay royalties as specified under the agreements.

“The precise terms are confidential between the parties.

“All litigation pending between the parties will be dismissed, and Amgen has acknowledged the validity of AbbVie’s intellectual property related to Humira.”

AbbVie executive vice president, 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.

“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.

“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.”

BMO Capital Markets analyst Alex Arfaei said in a research note the Humira settlement “adds unexpected royalties during the biosimilar years and indicates that AbbVie’s patents … are defensible.”