Court Settlement Delays Amgen's Humira Biosimilar for Five Years in US


Amgen settles with AbbVie over Humira biosimilar

Under terms of the agreement, AbbVie will grant nonexclusive 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.

Humira is now the world's biggest-selling drug, generating $16 billion in revenues in 2016. USA sales won't begin until January 31, 2023, according to the news release. While Amjevita was approved by the U.S. Food and Drug Administration a year ago, Amgen and AbbVie has been tangled up in patent litigation.

The two companies announced that they have reached a global settlement to resolve all pending litigation regarding the Amgen biosimilar, known as Amjevita in the USA and as Amgevita in some other nations.

"Amjevita 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, vice president of biosimilars at Amgen, said in a statement. Biosimilars, which are similar versions of brand-name drugs that aim to be more affordable, have gained steamed since the 2010 Affordable Care Act.


To protect this lucrative crown jewel from rivals developing their own versions that aim to be more affordable, AbbVie has built a wall around Humira with roughly 100 patents that have varying expiration dates.

Amgen may have settled because it couldn't win on certain patents, said EvercoreISI analyst Umer Raffat, and litigation could have stretched into 2021 or even later. PRICING PRESSUREThe deal announced today "creates a level of assurance" for Wall Street investors that Humira sales won't be dampened by Amgen, at least not yet, said Tony Butler, a New York-based managing director and senior biopharma analyst at Guggenheim Securities. In the interim, companies have been battling each other in court over intellectual-property rights.

AbbVie ABBV, +4.98% shares surged 6.2% in morning trade on the news, putting them on track for a record close.

The drug was the fourth biosimilar to get approval in the USA and the first for Amgen. The current suit against Boehringer involves eight patents, though AbbVie said it's identified a total of 74 patents that may be infringed by Boehringer's copy. She added that AbbVie has to remain vigilant though. Still, there could be a catch (and a boost to AbbVie). "AbbVie buys more time for top-selling Humira" originally appeared in Crain's Chicago Business.

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