On November 30, Pfizer announced a settlement with AbbVie on a worldwide patent lawsuit for adalimumab biosimilar drugs.
According to the agreement, in the European market, Pfizer's adalimumab biosimilar drug can be marketed after obtaining EMA approval.However, in the US market, Pfizer needs to market adalimumab biosimilar drugs after November 20, 2023.Other financial details of the agreement were not disclosed.
This is the seventh company so far to settle a Humira patent lawsuit with AbbVie.The first six are Amgen, Fresenius Kabi, Samsung Bioepis, Mylan, Sandoz, Momenta.Among them, Amgen and Sandoz's adalimumab analogues have been approved by the FDA in 2016 and 2018.
Since the patent protection of adalimumab in Europe has expired, the development enterprise is no longer limited.However, for the U.S. market, judging from the terms of the agreement signed by the current seven companies, the sooner the settlement with AbbVie is reached, the earlier the time to obtain a license to market adalimumab analogues in the United States.Pfizer's adalimumab-like drug is currently in Phase III clinical stage.
7 companies that have reached a settlement with AbbVie
Boehringer Ingelheim's adalimumab analogue has been approved for listing by the FDA in 2017, but its patent litigation with AbbVie is still in progress.Boehringer still hopes to pass the patent challenge and make his Cyltezo available in the United States by 2023.
Humira is the best-selling drug in history, with US market sales reaching 123.600 million US dollars, the market share of other countries and regions accumulated 6 billion US dollars.At present, the European market has high acceptance of biosimilar drugs and fierce price competition.At the end of October, it was reported that Humira's pricing would drop by 80%, and AbbVie later rumored the news.But in any case, Humira's market competition has arrived.
AbbVie management believes that biosimilar drugs have little effect on Humira's 2019 sales revenue.Humira's international revenue is forecast to fall by $1.7 billion in 2019, but there is still a 10% to 12% increase in the U.S. market, so total global revenue in 2019 will not change much compared to 2018.