AbbVie inks Humira patent deal No. 7, delaying Pfizer's U.S. biosim launch until late 2023

Pfizer is the latest biosimilar drugmaker to settle on a 2023 launch date for a Humira copy. (Pfizer)

AbbVie is on a hot streak striking patent deals to protect its top drug, Humira. Even as Boehringer Ingelheim has opted to fight the company’s patent claims in court, Pfizer has decided it’s in its own best interest to settle on a late 2023 biosimilar launch date.

Under a licensing agreement with AbbVie, Pfizer can launch its Humira biosim on Nov. 20, 2023. The date falls after biosim launch timelines for several other drugmakers that have already inked their own patent deals with AbbVie.  

Amgen, for instance, was the first to settle with AbbVie and gets the earliest U.S. Humira biosimilar launch date of Jan. 31, 2023. Samsung Bioepis followed with its own deal this year that allows its marketing partner Merck to launch a biosim in the U.S. on June 30, 2023. 

Free Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This webinar will discuss the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

Since both of those deals, AbbVie has rung up a series of settlements with MylanSandoz, Fresenius Kabi, Momenta and now Pfizer on staggered launch dates through the second half of 2023.  

In Europe, Pfizer can launch its biosim after it secures regulatory approval. The program is in phase 3, according to Pfizer’s pipeline (PDF). 

Meanwhile, several companies have already launched their biosims in Europe under their own settlements with AbbVie, and the competition is starting to hurt AbbVie’s pricing power in the markets. On AbbVie’s third-quarter conference call, AbbVie CEO Richard Gonzalez said discounting has been at the high end of AbbVie’s projections, ranging from 10% to 80%. 

RELATED: AbbVie offers up 80% Humira discount in EU tender market to hold off biosimilars: report 

Boehringer Ingelheim has opted against settling. The company is still eying the lucrative U.S. market and this week said it’s pulling out of biosim development activities elsewhere. A spokesperson said BI is committed to making its Humira biosim, Cyltezo, “available to U.S. patients as soon as possible and certainly before 2023.” 

Humira generated $12.36 billion in the U.S. last year, compared with about $6 billion in all other markets.

Suggested Articles

Shionogi's newest antibiotic Fetroja has now earned the FDA's approval, but will a mortality-rate warning scuttle the drug's chances?

Novartis' Sandoz doubled down in Japan as Lupin retreated. Dr. Reddy's posted a loss tied to its Zantac recall. Aslan's varlitinib failed again.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.