After two decades of unchallenged reign on the counters of American pharmacies, it is time for major upheavals for AbbVie’s flagship drug, Humira, used in the treatment of chronic inflammatory diseases (rheumatoid arthritis, Crohn’s disease, psoriasis …). The Lake County laboratory, located in the suburbs of Chicago, is preparing to give up one of its last bastions: its very lucrative monopoly in the United States, which contributed most of the more than 200 billion dollars (approximately 199.84 billion euros) of sales made by this single drug in the world for twenty years.
From 2023, no less than a dozen biosimilars – these almost identical copies of biological drugs whose patent has fallen into the public domain – will come to compete with its product across the Atlantic. Good news for patients, who will benefit from less expensive treatments, but a huge challenge for AbbVie, which will have to face a difficult equation: how to compensate for the significant declines in income to come from its star drug?
The American firm is not alone in this case. This is a classic step in the life cycle of a drug. When a new molecule with therapeutic properties is discovered, the laboratory behind the discovery files a patent to protect its innovation. Awarded for a limited period of twenty years, the latter gives him commercial exclusivity on the sale of his product. During this period, competition from generics or biosimilars is prohibited, to allow the laboratory to make its investment profitable. Once expired, the patent falls into the public domain, opening the door to competition from generic drugs or cheaper biosimilars, which mechanically reduce sales of the original.
To absorb the shock, manufacturers are stepping up their efforts to fill their portfolio with new drugs
However, the years ahead promise to be perilous for many Big Pharma companies. These will be faced with the expiration of the patents of some of their most profitable drugs, the blockbusters, those which exceed a billion dollars in turnover per year and which provide a large part of their income. In addition to Humira, the world’s largest drug in terms of sales (excluding vaccines against Covid-19), other products, such as Keytruda (17.2 billion dollars in 2021), from Merck MSD, the Opdivo ($7.5 billion) and Eliquis ($10.8 billion), Bristol Myers Squibb, Stelara ($9.1 billion), Johnson & Johnson, Trulicity ($6.5 billion dollars), Eli Lilly, Entresto ($3.5 billion) and Gilenya ($2.8 billion), Novartis, or Ibrance ($5.4 billion), Pfizer, are expected to face competitors by 2028. This coming upheaval, dubbed by industry observers the “patent cliff”, could slash pharmaceutical companies’ revenues by up to $180 billion over the next few years. next six years, according to estimates by PwC.
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