AbbVie raised its 2018 earnings guidance last week, based in part on increased sales of Humira (adalimumab). In its report on its second-quarter 2018 financial results, AbbVie noted a 10% increase in U.S. sales of Humira in the quarter, and stated during the earnings call that it expected U.S. sales growth for Humira to be approximately 11% in the third quarter. On the earnings call, AbbVie’s CEO also discussed AbbVie’s patent portfolio on Humira and AbbVie’s various settlement agreements concerning biosimilar versions of Humira, stating, “[i]n the US we have patents with exp[i]ration dates well beyond 2030 and our earliest to expire IP is June, 2022. …. Given the breadth of the IP that we have and the overwhelming strength of the patents that we have, the license entry date represents what I would describe as a fairly negotiated license agreement that expedites biosimilar entry into the United States.”
As we’ve covered previously, AbbVie has entered patent license agreements with Amgen (whose biosimilar product Amjevita was approved in September 2016 and is permitted to launch in the U.S. on January 31, 2023 under the settlement agreement), Samsung Bioepis (who does not yet have an approved biosimilar adalimumab product in the U.S., and if approved is permitted to launch in the U.S. beginning on June 30, 2023), and, most recently, Mylan (who does not yet have an approved biosimilar adalimumab product in the U.S., and if approved is permitted to launch in the U.S. beginning on July 31, 2023).
Another biosimilar adalimumab product is still the subject of pending litigation: Boehringer Ingelheim’s Cyltezo product was approved in August 2017, and is the subject of an ongoing suit in which trial scheduling is slated to be discussed after the close of claim construction and fact and expert discovery (expert discovery is scheduled to close by May 29, 2020). And Sandoz, whose aBLA for its proposed adalimumab biosimilar product was accepted for FDA review in January 2018, has challenged several AbbVie patents on Humira in IPR proceedings (see here and here).
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