Facing No US Biosimilar Competitors, Humira Grows by $3.8 Billion

In its second quarter earnings call, drug maker AbbVie revealed that, in the United States, Humira sales grew by $3.8 billion last quarter, up 7.7% from the prior year, with volume growth of approximately 7%.

Additionally, in the third quarter of this year, the company expects US Humira sales to grow by approximately 8%.

Furthermore, AbbVie’s spate of settlements with biosimilar developers with products referencing Humira “reinforces our confidence that we will not see direct biosimilar competition in the US until 2023,” said Rick Gonzalez, chief executive officer of AbbVie. Gonzalez also added that the company does not expect a prospective arrival of a biosimilar etanercept—2 of which are approved but unlaunched in the United States—to impact US Humira sales.

International sales of Humira, however, were down by $1.1 billion, or 31% on an operational basis, which Gonzalez said reflects “the impact of direct biosimilar competition in Europe” and other ex-US markets.

Other drivers of AbbVie’s revenue this quarter—which totaled more than $8.2 billion and exceeded expectations—were the oncology drugs ibrutinib (Imbruvica) and venetoclax (Venclexta) as well as risankizumab (Skyrizi), a treatment for plaque psoriasis.

Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, added that the company expects an approval for upadacitinib shortly in the indication of rheumatoid arthritis without the convocation of an FDA advisory committee. Severino indicated that, while he cannot speak to the FDA’s position on whether JAKs as a class share similar safety concerns, such as those that led to a new warning for tofacitinib just last week, “we’ve said consistently [that] our program hasn’t demonstrated that risk.”

In looking toward the future, Gonzalez said that AbbVie’s acquisition of Allergan will give the company an opportunity to grow its non-Humira business, and to derive “significant additional earnings” when Humira faces US competition.