Humira Biosimilar Agreement

Humira Biosimilars captured 15 percent of the European market in February, the fourth month since its launch, Bernstein analyst Ronny Gal wrote in a recently published research note. Gal predicted that biosimilars, which occupy 50% of the Humira market in Europe within a year, would remain a possibility. BI is following the steps of Coherus, Pfizer, Amgen, Mylan, Samsung Bioepis, Sandoz, Fresenius Kabi and Momenta, which have also entered into contracts with the Humira manufacturer. None of their products will be released on the U.S. market until 2023. The first will be the participation of Amgens Biosimilar Amjevita in January 2023. Acceptance of biosimilars in the U.S. has been disappointing so far, with infliximab biosimilars, in particular, having adopted a very limited proportion of patients since they were marketed four years ago. GlobalData believes, however, that there are enough factors that distinguish the biosimilar markets from adalimumab and infliximab to put them on different business trajectories. As part of the licensing agreement, Pfizer will be allowed to market its imitation drug in Europe after EMA approval and in the United States from November 20, 2023. All ongoing disputes between the parties are now withdrawn.

The villains` holdout, Boehringer Ingelheim, remains a prisoner of an ongoing legal challenge. It has a licensed Humira biosimilar, Cyltezo (adalimumab-adbm). Boehringer Ingelheim fought hard against what`s known as AbbVie`s patent thicket for the world`s best-selling drug, Humira. But in the end, the German company set up, as did its biosimilar producers. In particular, Humira will retain market exclusivity for uveitis, paediatric uveitis and juvenile hidradenitis suppurativa (HS) after the first placing on the market of adalimumab biosimilars. . . .