AbbVie stays busy while Humira copiers are on sale in Europe

It was a tumultuous fall for AbbVie. In the weeks leading up to the pharmaceutical company's third quarter earnings report, on Nov. 2, the group resolved a series of patent litigation cases. Drugs allegedly biosimilars from its flagship product, Humira, have been on sale in Europe. alliance of research programs and settled a ten-year allegation around the False Claims Act.

In the midst of a market downturn, AbbVie faces the uncertainty surrounding Humira, the world's best-selling drug and, therefore, a prime target for biosimilar manufacturers, who are almost identical copies of a product. original made by another company. While Wall Street predicts the secular question – what value does a post-Humira AbbVie have? – stocks are down, falling by 15% last month and 17% since January. The closing price of the stock on November 1st was $ 80.21.

Meanwhile, in the first nine months of 2018, the company achieved net sales of $ 24.4 billion, an increase of 19% over the same period last year.

Approved to treat rheumatoid arthritis and other autoimmune diseases, Humira generated more than $ 18 billion last year, accounting for 65% of the total sales of the North Chicago-based company. Humira's worldwide sales reached $ 15 billion in the first nine months of 2018, an operational increase of 9.5% over the same period of the previous year. AbbVie has not responded to requests for comment.

The company inherited Humira in 2013 following the split of Abbott, which had purchased the drug nearly 20 years ago when acquiring Knoll Pharmaceuticals, a division of BASF.

Patent protection has prevented copiers from entering the market for years, but several biosimilars went on sale in Europe in October. While AbbVie still has a decent market share abroad, the price of Humira is likely to drop as competition intensifies, said Ashtyn Evans, health care analyst at Edward Jones.

A launch in the United States is a major concern. Fresenius Kabi is the last company to enter into a non-exclusive intellectual property license with AbbVie to market its biosimilar Humira in the United States from 2023 and in Europe, with the agreement of the European Atomic Energy Agency. drugs. Amgen, Samsung Bioepis, Mylan and Sandoz, a division of Novartis, have also set launch dates in the United States in 2023. However, Boehringer Ingelheim has filed patent litigation with AbbVie for its biosimilar approved by the FDA , Cyltezo. in the United States because of what he calls "the patent grove" of AbbVie. When calling AbbVie's results for the third quarter, President and CEO Richard Gonzalez said that he was confident in the company's position and that the fact that five sophisticated companies agreed to settle "speaks for itself".