Humira Biosimilar Agreement

But the first three months of 2019 began to show the effect of biosimilars. In the first months of accession to Europe, total sales decreased by 6% compared to the same period in the previous year. European sales of brand biologism fell by more than 25%. From now on, Amgen will have the first breach in the lucrative U.S. market of Humira. The company was the first to enter into a patent agreement with AbbVie and secure a launch date of January 31, 2023. At the other end of the spectrum, at the end of last year, Pfizer colored the seventh patent contract with AbbVie and agreed on a biosimilar rollout on November 20, 2023. Biologic drugs have changed standards of care for patients with autoimmune diseases. However, the considerable costs associated with the development and manufacture of these complex drugs have led to an explosion in the cost of managing these patients. While stakeholders had hoped that the introduction of biosimilars would help address rising health costs through competitive prices, it has not yet had the desired effect in the United States.

In particular, the ingestion of biosimilars on J-Js Remicade (Infliximab) remains recalcitrant. With this precedent, the big question is whether the biosimilars of Humira (Adalimumab), the originator of the blockbuster AbbVie, will present similar trends when they are released in the United States in 2023. The comparison marks a turning point in the U.S. biosimilars market, as BI was the only remaining biosimilar developer with an approved or late product that had not yet reached an agreement with AbbVie. The IB had previously informed the Center for Biosimilars® that it had committed to «making [the biosimilar] available to American patients as soon as possible and certainly before 2023.» The financial details of all agreements remain confidential. When it came to agreeing to a licensing agreement with AbbVie, Boehringer was the last to try to do so after his fight to market his Cyltezo biosimilar was tried. If successful in its litigation, Boehringer`s Cyltezo would be the first biosimilar to enter a US market worth $13.6 billion (11.9 billion euros) in 2018. AbbVie has granted a non-exclusive patent license that allows Pfizer to sell its biosimilar humira (adalimumab) in many countries around the world, ending Pfizer`s patent litigation and holding back another competitor for the next five years. With the introduction of Mylan`s Biosimilar product after the license opens on July 31, 2023, the company will be required to pay royalties to AbbVie for the licensing of Humira patents. The agreements granted Amgen a non-exclusive intellectual property license for Humira. The term of the licence begins in most European Union countries on 16 October 2018 and 31 January 2023 in the United States. Biosimilar absorption in the United States has been disappointing so far, with infliximab biosimilars, in particular, receiving a very small proportion of patients since their launch four years ago.

GlobalData believes, however, that there are sufficient factors that differentiate the biosimilar, adalimumab and infliximab markets to potentially lead them to different trade pathways.