Thursday, 14 Nov 2019

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

Psoriasis Risk Increased with TNF Inhibitors in Juveniles

Children with inflammatory diseases who were treated with tumor necrosis factor (TNF) inhibitors had a higher rate of incident psoriasis than those not exposed to these biologics, a single-center retrospective study found.

The Shame Behind Adalimumab Biosimilars

JAMA has an article this week on the shift from biologic drugs to less expensive therapeutic biosimilar agents. The impact of biosimilars can be easily represented by the shift from adalimuamb - a biologic with nearly $19 billion in sales in 2018 - to any one of the four FDA approved biosimilars for adalimumab (see the daily download for slides on new adalimumab and other biosimilars).

Pain Persists Despite TNF Inhibitor Use

Control of pain in patients with rheumatoid arthritis (RA) often focuses on control of inflammation as a means to better control pain. However, a new claims data study shows that while anti-tumor necrosis factor inhibitor (TNFi) may lower the use of opioids, the reduction is nominal, suggesting that a substantial amount of pain is not adequately addressed by TNFi - a potent anti-inflammatory approach.

Adalimumab and Pregnancy Outcomes

A prospective study of birth outcomes to mothers exposed to adalimumab (ADA) between 2004 and 2016 was conducted by Organization of Teratology Information Specialists (OTIS) Research Center at the University of California San Diego, and showed that ADA exposure was not associated with an increased risk for any of the adverse outcomes examined.

Enbrel Patent Battle Won by Amgen

The ugly, legal, financial underbelly of US biosimilar drug development showed up in court last Friday, when a U.S. judge upheld two of Amgen's patents for Enbrel, thwarting a legal challenge by Novartis/Sandoz over its etanercept-szzs biosimilar, Erelzi. 

Sandoz won FDA approval for their etanercept biosimilar in 2016, but has not been able to market Erelzi because of Amgen’s extended patent protection (till 2029).