Amgen and AbbVie reach a settlement on Humira biosimilar patent litigation

From  Reuters (September 28, 2017)

Amgen Inc has reached a settlement with AbbVie Inc that will delay the U.S. launch of Amgen’s cheaper biosimilar version of AbbVie’s cash cow, the blockbuster rheumatoid arthritis drug Humira, until Jan. 31, 2023, the companies said on Thursday (see also  AbbVie news release and Amgen/PR Newswire)

Humira, known chemically as adalimumab, is by far the world’s top-selling prescription medicine with second-quarter global sales of $4.7 billion, putting it on track for annual sales exceeding $18 billion.  The settlement, which removes a major overhang for AbbVie given its dependence on Humira, sent its shares to an all-time high of $90.95 before settling back to $89.87, up 6 percent.  Under terms of the settlement, which ends all pending patent litigation between the companies, AbbVie said it will be entitled to unspecified royalties on sales of Amgen’s biosimilar of Humira.

The Humira settlement “adds unexpected royalties during the biosimilar years and indicates that AbbVie’s patents … are defensible,” BMO Capital Markets analyst Alex Arfaei said in a research note.  The settlement also allows Amgen to begin selling its biosimilar of Humira in Europe on Oct. 16, 2018.

”This agreement will allow us to secure a strong foothold in the $4 billion European adalimumab market,” Scott Foraker, head of biosimilars for Amgen, said in a statement.

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.

Commentary:

Adalimumab, marketed as Humira, is a fully human monoclonal antibody against tumor necrosis factor.  It has been approved for multiple indications (see Prescribing Information) and, as a result, has attained blockbuster status for several years.  It is therefore, not surprising that several companies are vying for a share of the Humira market by developing adalimumab biosimilars.  Unlike small molecule generics, which only require bioequivalence studies for approval, biosimilars must demonstrate clinical efficacy, in addition to rigorous CMC and molecular characterization, including immunogenicity studies.  Although several biosimilars are currently approved and marketed in the European Union, only 5 have been approved in the US (see here).  The recent approval of adalimumab biosimilar from Amgen, has ushered in a flood of other biosimilar monoclonal antibodies as the patents on the innovator molecules begin to expire (see here).

© Copyright M. Loghman-Adham, MD

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