AbbVie's immunology blockbuster-to-be Skyrizi picks up first global approval

As Humira heads toward the end of its exclusive life in the U.S. and faces new competition in Europe, AbbVie is set for its next blockbuster launch thanks to an approval in Japan.

Japan’s Ministry of Health, Labour and Welfare approved AbbVie's Skyrizi to treat three types of psoriasis and psoriatic arthritis, giving the IL-23 inhibitor its first approval on the planet. Skyrizi won backing from a key EU committee last month and the U.S. FDA is expected to issue its decision by the end of June.

Skyrizi is pegged with blockbuster expectations, but peak sales estimates are just a fraction of Humira's megablockbuster totals. Clarivate Analytics, for one, sees Skyrizi pulling in $1.74 billion in 2023, while Humira nabbed almost $20 billion last year. And AbbVie has a partner on Skyrizi, Boehringer Ingelheim, who will share in the sales haul.

Japan's MHLW approved the drug based on Phase 2 and 3 trials in Japanese patients with plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis, plus a global phase 2 study in psoriatic arthritis patients. Syrizi is approved to treat adults who haven’t had adequate treatment with other options.

Boehringer originally developed the drug, while AbbVie is leading development and commercialization. BI has an option to copromote the drug in asthma, according to its website. 

If things go according to plan at AbbVie, Skyrizi will be one of a couple blockbuster launches coming in 2019. Rheumatoid arthritis candidate upadacitinib is likely to score a U.S. approval in August, Clarivate predicts, and a European approval in October. And the analysts believe that drug will generate $2.2 billion by 2023.

RELATED: From AbbVie's upadacitinib to new gene therapies: Pharma's 2019 blockbuster launches, ranked 

AbbVie will need both drugs to pitch in extra revenue as Humira biosim competition ramps up. The company started facing new competition in Europe last fall, and U.S. competition is coming in 2023.

Unlike small-molecule generics, biosims don't typically take a huge bite out of brand sales immediately, but with multiple copycats gunning for Humira sales—and payers keen to save on the pricey drug—the competition could take a serious toll.

RELATED: AbbVie offers up 80% Humira discount in EU tender market to hold off biosimilars 

“We have long been planning and preparing for the event that is now upon us,” CEO Richard Gonzalez told analysts on the company’s fourth-quarter conference call. Aside from immunology, the company has oncology and neuroscience drugs in its pipeline in various stages.

In Europe, Humira biosims launched in October have caused more suffering than AbbVie initially expected thanks to aggressive discounting. In one tender country, AbbVie reportedly discounted its drug by 80% to keep the market.