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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
At least 70 patents for Humira will protect the legacy product from biosimilar competitors, according to information presented during the company’s third-quarter earnings call.
According to AbbVie CEO Richard Gonzalez, the company plans to aggressively defend its patents for Humira (adalimumab), many of which, Gonzalez says, will protect the product from biosimilar competitors until at least 2022. Although the composition patent for Humira expires in 2016, the later patents covering the formulation and method of manufacture of the drug and those related to the product delivery device will effectively stave off biosimilar competitors for at least the next six years, Gonzalez said in a third-quarter earnings call. Beyond 2022, the company says it has country-specific strategies to handle market erosion.
Gonzalez said AbbVie has a total of 70 patents protecting Humira, with 24 patents related to Humira’s method of manufacture, and those “expire no earlier than 2027.” Its 14 patents related to the formulation of the product expire “no earlier than 2022,” Gonzalez said during the call. Humira, as the “first human therapeutic antibody ever approved by the FDA,” has patents reflecting the work of more than 100 clinical trials spanning 18 years, company representatives pointed out. He noted that it will be very challenging for Humira biosimilars to come to market, despite the fact that various companies already have them in development. Gonzalez pointed out that “a biosimilar company will have to contend with our method of treatment patents for every indication for which it seeks approval, as well as our formulation and manufacturing patents, which are not limited to any particular indication.”
Protection of market share for Humira is crucial, as the company reports that of the approximately $37 billion in revenue it expects in 2020, nearly half of that figure ($18 billion) is expected to come from global sales of Humira alone. The company also said it expects Imbruvica (ibrutinib), a second-line drug approved for the treatment of chronic lymphocytic leukemia and mantle cell lymphoma, to achieve blockbuster status in 2015 with projected revenues of approximately $5 billion by 2020.
Competition from products with other mechanisms, such as those that target IL-17, may have more of an impact with patients than biosimilars of Humira, Gonzalez admitted. Novartis' Cosentyx (secukinumab) demonstrated in clinical trials to be superior to Enbrel (etanercept), a TNF inhibitor similar to Humira, and Stelara (ustekinumab), which is an IL-12 and IL-23 inhibitor. Although Gonzalez said that IL-17 products have “a pretty strong profile,” he added that drugs employing the new mechanism will likely be “relegated to the failure patient population, because physicians are comfortable.”
Other players in the IL-17 space include Eli Lilly's IL-17 inhibitor ixekizumab-which demonstrated superiority over Enbrel as well-and AstraZeneca's brodalumab, which Valeant recently licensed. Although Amgen had a prior development deal with AstraZeneca for brodalumab, Amgen ended the deal following reports that the drug may be related to increased incidences of suicidal ideation.
Source: Seeking Alpha