Friday, 19 Jan 2018

You are here

Amgen-Abbvie Settle Humira Biosimilar Patent Dispute

Amgen's biosimilar version of adalimumab (Humira) was FDA-approved in September 2016 and given the trade name Amjevita (generic: adalimumab-atto). This new TNF inhibitor biosimilar has not yet been to market because of legal wranglings over patent issues by Abbvie's Humira. Yesterday, Abbvie announced a global resolution to its patent dispute with Amgen over Humira (citation souce: https://buff.ly/2hAcH7g).

Amgen's settlement with AbbVie will delay the U.S. launch of Amgen’s Amjevita biosimilar (for the treatment of rheumatoid arthritis) until Jan. 31, 2023.

AbbVie is said to have more than 100 patents surrounding Humira. The U.S. patent for Humira expired in December 2016, but the additional patents, which cover things such as manufacturing methods and the drug's formulation, expire in the 2020s.

The settlement details include the following:

  • AbbVie will be entitled to unspecified royalties on sales of Amgen’s biosimilar of Humira.
  • Amgen expects to launch Amgevita in Europe on Oct. 16, 2018, and Amjevita in United States on Jan. 31, 2023.

  • AbbVie will grant patent licenses for use and sale of Amgevita/Amjevita worldwide, on a country-by-country basis.

  • Amgen has acknowledged the validity of AbbVie's intellectual property related to Humira.
  • The settlement ends all pending patent litigation between the two companies. 

Amgen was the first company to win U.S. approval for a Humira biosimilar, but delayed selling it until the patent situation was resolved. Other companies that also intend to market their own biosimilar versions of Humira are still challenging its patents.

This action substantially delays the availability of biosimilar therapy in the U.S and may be viewed as a setback to legislators who have been touting the savings afforded by newer biosimilars.

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

Add new comment

More Like This

Why TNF Inhibitors May Work in Some Autoinflammatory Patients

The NLRP3 inflammasome is a critical component of the innate immune system and activation of NLRP3 inflammasome results in caspase-1–dependent secretion of the proinflammatory cytokines IL-1β and IL-18. Gain-of-function missense mutations in NLRP3 is thought to drive many of the autoinflammatory diseases, especially the cryopyrin-associated periodic syndromes (CAPS).

Infliximab Does Not Increase Perioperative Infection

Staying on a TNF inhibitor (TNFi) throughout major surgery has generatlly been associated with higher rates of perioperative infection (https://buff.ly/2iBFVjp).  On the other hand, discontinuation of the TNFi prior to surgery is associated with lower rates of  infection (https://buff.ly/2iAFZQf)

CALM Study: Tight Control with Anti-TNF Wins in Crohn's Disease

Not unlike rheumatoid arthritis and other inflammatory disorders, therapeutic efficacy in Crohn's disease (CD) is often assessed clinically. There is growing use and interest in biomarkers of intestinal inflammation, such as faecal calprotectin and C-reactive protein. But Lancet has now reported a clinical trial has shown that a tight control strategy can yield better responses to TNF inhibitors when compared to usual care. 

Another Adalimumab Biosimilar Approved

On Friday August 25th, the FDA approved another adalimumab biosimilar: Cyltezo (generic name: adalimumab-adbm).

Adalimumab Biosimilars Adding Up

Reuters reports that yet another adalimumab biosimilar has been approved by European Union regulators.

The new drug is named Imraldi, and is manufactured by Samsung Bioepis, a company who has several biosimilars approved or in development for worldwide use.