Amgen has agreed to delay the U.S. launch of its FDA-approved biosimilar version of AbbVie’s Humira® (adalimumab) until 2023, under a settlement the companies announced today that ends their patent dispute over the multi-indication blockbuster drug.
Amgen’s Humira near-copy Amjevita™ (adalimumab-atto) was the fourth biosimilar authorized for sale in the U.S. when it won FDA approval in September 2016. Six months later in March 2017, Amgen won European Commission approval for the biosimilar, which will be marketed in Europe as Amgevita™ (biosimilar adalimumab).
However, the patent dispute with AbbVie has effectively kept the drug from reaching both markets.
The settlement calls for AbbVie to grant Amgen a nonexclusive license to AbbVie's Humira-related intellectual property. That license will begin October 16, 2018, in most European countries—and January 31, 2023, in the U.S.
The companies said they agreed to license periods on a country-by-country basis for worldwide use and sale of Amgen’s Humira biosimilar, though their separate announcements did not furnish details on the dates and nations.
Also undisclosed were precise terms of the settlement, though AbbVie stated that it will receive royalties from Amgen. AbbVie also said that all litigation pending between the parties will be dismissed, and that Amgen has acknowledged the validity of AbbVie's intellectual property related to Humira.
“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,” Scott Foraker, vp and general manager of biosimilars at Amgen, said in a company statement. “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.”
Laura Schumacher, evp, external affairs, general counsel, and corporate secretary at AbbVie, added in her company’s statement: “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,” Schumacher added.
Humira is AbbVie’s top-selling drug—and ranked No. 1 among the Top 15 Best-Selling Drugs of 2016 as listed by GEN, with 2016 sales of $16.078 billion, up 14.7% from 2015. During the first half of this year, Humira racked up $8.834 billion in sales, up 14.3% from January-June 2016.
‘Both Sides of Its Mouth’
More than a month before the FDA approved the Humira biosimilar, AbbVie sued Amgen in U.S. District Court for the District of Delaware. AbbVie accused Amgen of infringing on 61 of more than 100 U.S. patents related to Humira—10 of which were asserted by AbbVie in the lawsuit.
AbbVie also cited Amgen’s arguments in a separate court case Amgen filed against Novartis’ Sandoz unit, seeking to delay its biosimilar Zarxio® (filgrastim-sndz), a near-copy of Amgen’s leukocyte growth factor Neupogen® (filgrastim): “In seeking to defend its copycat actions here, Amgen is speaking out of both sides of its mouth.”
Sandoz won its dispute with Amgen in June. A unanimous U.S. Supreme Court reversed a pro-Amgen decision by the U.S. Court of Appeals for the Federal Circuit (CAFC) that forced Sandoz to wait 180 days before it could launch Zarxio. The High Court’s decision handed biosimilar developers a key victory that could generate millions in future sales.
The settlement with AbbVie is Amgen’s second announcement related to its growing biosimilar effort this week and its third this month. On Tuesday, Amgen and Simcere Pharmaceutical announced an exclusive agreement to co-develop and commercialize in China four “undisclosed biosimilars in the areas of inflammation and oncology.”
Under their agreement, whose value was not disclosed, Amgen agreed to oversee co-development, marketing approval applications, and manufacturing of the biosimilars—while Simcere agreed to oversee distribution and commercialization in China, where Amgen will have a limited right to co-promote the products.
The biosimilars covered by the agreement with Simcere are part of Amgen's existing biosimilars portfolio, which has grown to 10 programs. That portfolio includes four oncology biosimilars being co-developed with Allergan. The companies in July submitted a Biologics License Application seeking FDA approval for one of those four, ABP 980, a biosimilar of Herceptin® (trastuzumab).
Another Amgen–Allergan cancer biosimilar on September 14 won the first U.S. approval for a biosimilar cancer treatment following FDA authorization of the companies’ Mvasi™ (bevacizumab-awwb), a near-copy of Roche subsidiary Genentech’s Avastin® (bevacizumab).