On November 30, Pfizer announced a settlement with AbbVie on a worldwide patent litigation against adalimumab biosimilars.
Under the agreement, in the European market, Pfizer’s adalimumab biosimilars will be available for sale upon approval by the EMA. However, in the US market, Pfizer needs to market adalimumab biosimilars on or after November 20, 2023. Other financial details of the agreement between the parties have not been disclosed.
This is the seventh company to reach a settlement with AbbVie on the Humira patent litigation. The first six were Amgen, Fresenius Kabi, Samsung Bioepis, Mylan, Sandoz, and Momenta. Among them, Amgen and Sandoz’s adalimumab analogs have been approved by the FDA in 2016 and 2018.
Since the patent protection of adalimumab in Europe has expired, development companies are no longer limited. However, for the US market, the earlier the agreement between the seven companies, the earlier the settlement with AbbVie, the earlier the license to obtain the adalimumab analogue in the US. Pfizer’s adalimumab-like drug is currently in Phase III clinical stage.
Boehringer Ingelheim’s adalimumab analog has been approved for FDA approval in 2017, but its patent litigation with AbbVie is still ongoing. Boehringer still hopes to make his own Cyltezo listed in the US by 2023 through patent challenges.
Humira is the best-selling drug in history. In 2017, the US market sales revenue reached 12.36 billion US dollars, and the market share of other countries and regions totaled 6 billion US dollars. At present, the European market has high acceptance of biosimilar drugs and the price competition is fierce. At the end of October, Humira’s pricing was down 80%, and AbbVie subsequently rumored the news. But in any case, Humira’s market competition has arrived (see: Humira Europe’s 80% price cut is misunderstanding? Is the patent expiration effect exaggerated?).
AbbVie management believes that biosimilars have little impact on Humira’s 2019 sales. It is predicted that Humira’s international income will fall by US$1.7 billion in 2019, but the US market still has an increase of 10%~12%. Therefore, the total global income in 2019 has not changed much compared to 2018.