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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.