As a result, Amgen expects to launch Amgevita in Europe on Oct. 16, 2018, and Amjevita in the U.S. on Jan. 31, 2023. "The settlement agreement provides certainty and clarity on timing, eliminates costly litigation and brings Amgen closer to the launch of one of our first biosimilars by licensing Abbvie's intellectual property that extends beyond our agreed upon launch dates," Amgen spokeswoman Kelley Davenport told BioWorld.
The settlement and nonexclusive licensing agreement ends U.S. litigation between the two companies over 10 Humira-related patents that have expiration dates ranging from 2022 to 2033. "In addition, Abbvie had asserted that it has over 50 other applicable patents," Davenport said.
Although no financial terms were disclosed, Abbvie is being cast as the big winner in the deal. Not only does the agreement provide the North Chicago-based company with royalties, it likely pushes back the threat of U.S. biosimilar competition to Humira, the all-time blockbuster biologic that provides the lion's share of Abbvie's revenue.
Given Humira's mega-blockbuster status, it has been targeted by nearly a dozen biosimilars that have been approved, are under review or are in late stage development for the EU and U.S. markets. Amgevita/Amjevita was the first approved in both markets, getting the nod from the FDA last September and from the EMA in March.
Last month, the EMA and FDA each approved one other biosimilar referencing the Abbvie drug. The FDA greenlighted Boehringer Ingelheim GmbH's (BI) Cyltezo, and the EMA authorized Samsung Bioepis UK Ltd.'s Imraldi.
Earlier, talk of biosimilar competition, especially in the U.S. where Humira generated more than $10.4 billion in sales last year, set Abbvie's 2016 earnings call abuzz. At the time, Abbvie Chairman and CEO Richard Gonzalez said the U.S. market for Humira was pretty much protected until 2022, although biosimilars could launch elsewhere as early as the fourth quarter of 2018. (See BioWorld Today, Jan. 31, 2017.)
While the agreement announced Thursday provides several more months of breathing room in the U.S. for Humira, it aligns with Gonzalez's prediction for the rest of the world. Outside of the U.S., the drug produced more than $6 billion in sales last year. Globally, it accounted for almost 63 percent of Abbvie's total net revenue.
Shift in forecast
As a result of the settlement with Amgen, Credit Suisse research analyst Vamil Divan now expects Humira's worldwide sales to peak at about $20 billion in 2020 and then drop to about $15.6 billion in 2023 after Amjevita and possibly other biosimilars launch in the U.S. By 2026, Humira would still be a blockbuster, but its global sales may be in the $9.6 billion range, Divan noted.
Although the deal pushes Amjevita's debut back further than expected, it is good for Amgen, as it sets a definite timeline for a U.S. launch while clearing the way for nearer term revenue growth with Amgevita in Europe. "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.
So far, the EU market has been more receptive to biosimilars than the U.S. market, which is still in its infancy. That fact could help Amgen establish its biosimilar brand in the EU and supplement its revenue stream while waiting for the U.S. market to gain confidence in biosimilars in general.
The agreement also removes the uncertain overhang of what could have been a lengthy, nasty patent battle. Abbvie has built a thick patent fence around its cash cow. “With so many patents, some might be invalidated, and others, while valid, may not be infringed upon,” Elaine Blais, a partner and patent attorney with Goodwin Procter LLP, told BioWorld.
Other patents would withstand a challenge. Amgen, of Thousand Oaks, Calif., lost in its bid to invalidate two formula patents through the inter partes review (IPR) process. Since Amgen named the patents in an IPR, "it is a safe assumption that Amgen's biosimilar . . . infringed those patents," said Umer Raffat, a senior analyst with Evercore ISI.
Meanwhile, Amgen, which is actively protecting the patents on its own blockbuster biologics from an onslaught of biosimilar challenges, was facing a November 2019 court date on 10 Humira patents. There was no certainty that Amgen would prevail and appeals could have dragged the litigation into 2021. "In addition . . . there were many more [patents] that Abbvie could have used to extend the litigation timelines further," Raffat said.
The agreement gives the sponsors of other Humira biosimilar candidates something to ponder. "The fact that Amgen is now parked in the U.S. until Jan. 31, 2023, may encourage others to challenge the [Humira] patents to try to get to market sooner," Blais said. However, she noted, the agreement likely includes an acceleration clause that would allow Amgen to launch earlier under certain circumstances.
The settlement indicates that Amgen recognized that Abbvie's patents weren't particularly vulnerable, said Kevin Noonan, a partner with McDonnell Boehnen Hulbert & Berghoff LLP. While other companies may want to beat Amjevita to the U.S. market, Noonan said they are faced with invalidating the same patents Amgen concluded were too hard to invalidate.
BI is already embroiled in litigation with Abbvie. The German company took down one of Humira's patents through an IPR, but Abbvie sued BI last month, claiming it has infringed eight other patents. In total, Abbvie has identified 74 patents that could potentially be infringed by the BI follow-on, said Jeffrey Holford, a Jefferies LLC analyst.
Looking ahead to when Humira has to compete with biosimilars, Divan said the agreement with Abbvie could give Amgen an edge. Since the two companies, both of which are recognized as strong regulatory players, now have interests that are a bit more aligned, "we think that could potentially make it more challenging for others to gain significant biosimilar share," he said.
Glancing even further down the road, RBC Capital Markets LLC analyst Kennen MacKay predicted a 30 percent peak penetration in the U.S. and 50 percent in the EU for all Humira biosimilars. Of that, he expects the Amgen biosimilars to take a 20 percent share of the total Humira biosimilar market with peak global Amgevita/Amjevita sales of $928 million in 2032.
Aside from all the forecasts and talk of market share, Blais said there's another takeaway from Thursday's deal that sponsors and investors should be watching for – that's how the FTC reacts to this first major biosimilar patent settlement.