AbbVie: Next-Generation Skyrizi and Rinvoq Are Showing Traction in Humira Space

With biosimilar competition closing in on AbbVie’s blockbuster Humira (adalimumab), the pharmaceutical giant reported strong sales for 2 next generation products it expects will retain its market dominance in the psoriasis and rheumatoid arthritis categories, which Humira covers.

Global net revenues for psoriasis drug risankizumab (Skyrizi), launched in May 2019, hit $355 million for the full-year 2019 and $216 million in the fourth quarter, the company said in a February 7 earnings call. Global net revenues for rheumatoid arthritis drug upadacitinib (Rinvoq), launched in August 2019, were $47 million for all of 2019 and $33 million in the fourth quarter.

AbbVie projected the combined 2020 revenues for Skyrizi and Rinvoq to be approximately $1.7 billion. “We expect Skyrizi and Rinvoq to have full coverage across the major disease areas for which Humira is currently approved, plus new areas such as atopic dermatitis,” Michael E. Severino, vice chairman and president of AbbVie, said during the call.

Both Skyrizi and Rinvoq “have demonstrated strong differentiated efficacy in their initial indications,” and AbbVie is also “making considerable progress to expand their uses in several additional immune-mediated diseases,” added Richard A. Gonzalez, chairman and chief executive officer.

Company officials are pinning their hopes on these new products as Humira market share erodes in Europe and faces biosimilar competition from multiple products that could enter the US market in 2023. Also, the company faces many legal actions against its Humira marketing practices and filing of over 100 patents related to the drug, which are alleged to have been filed mainly to prevent competition.

The company said 2019 Humira sales in the United States were $14.9 billion, up 8.6% versus 2018. “International Humira sales were approximately $950 million in the [fourth] quarter, down 25.4% operationally, reflecting biosimilar competition across Europe and other international markets,” said Robert A. Michael, executive vice president and chief financial officer.

Humira’s 2019 net revenues in Europe were $4.3 billion, a 31.3% decrease since the addition of biosimilar versions into the market, a trend expected to carry into the US when patents expire beginning in 2023.

In 2023 in the United States, Humira faces possible competition from at least 5 biosimilars from 5 makers: Amgen, Amjevita; Merck, Hadima; Boehringer Ingelheim, Cyltezo; Sandoz, Hyrimoz; and Pfizer, Abrilada.

AbbVie continues to grow, reporting a full-year net revenue of $33.3 billion, up 2.7%, despite the increasing biosimilar competition in the European market. This is largely due to Skyrizi and Rinvoq, but also hematology-oncology products ibrutinib (Imbruvica) and venetoclax (Venclexta), officials said.

Full-year global net revenues from hematology-oncology drugs were up 39.3% from 2018. AbbVie has built a substantial franchise with ibrutinib (Imbruvica) and venetoclax (Venclexta), which brought in nearly $5.5 billion in combined revenue. The company predicted strong, double-digit growth again in 2020.

“[Ibrutinib] remains the clear market share leader across all lines of therapy and [chronic lymphocytic leukemia] with the largest body of clinical evidence [and] a robust survival benefit…. We remain confident that [ibrutinib] will be a significant growth contributor for many years to come,” Gonzalez said.

AbbVie expects to close pending transactions on the acquisition of Allergan in the first quarter of 2020. The deal to buy Allergan for $63 billion is partly intended to shore up any revenue declines from Humira market share declines. The Allergan acquisition brings blockbuster revenues from Botox, neuroscience and gastrointestinal drugs.