- AbbVie continued to record strong revenue growth for its blockbuster biologic Humira (adalimumab) in the second quarter, with global sales rising nearly 14% year over year to $4.7 billion despite competition from new drug classes and entry of anti-TNF biosimilars into the U.S. market.
- Humira accounts for more than 65% of AbbVie's total revenues. How the drugmaker deals with rising competitive threats to its flagship franchise will be key to maintaining growth moving forward, even in light of a rapidly emerging oncology business headlined by Imbruvica (ibrutinib).
- Central to AbbVie's plans to maintain leadership in immunology are the experimental JAK1 inhibitor upadacitinib and the IL-23 blocker risankizumab."When you add these other two agents into the mix to our portfolio, it should give the opportunity to significantly grow our market share position," said AbbVie CEO Rick Gonzalez on Friday's earnings call.
Anti-TNF biologics like Humira, J&J's Remicade (infliximab) and Amgen's Enbrel (etanercept) have been among the industry's best-selling medicines for years, treating a broad range of prevalent chronic inflammatory conditions.
But there are signs those drugs' hold on the top ranks of pharma best-sellers may be slipping. Competition from fast-growing drugs such as Novartis' Cosentyx (secukinumab) and Lilly's Taltz (ixekizumab) poses a threat, as does the deep pipeline of biosimilar copies entering or set to enter the market in the U.S.
Already two biosimilar versions of J&J's Remicade have launched, although the pharma giant has yet to see a significant dent in revenues. Other copycat biologics, including a biosimilar of Humira, have been approved by the Food and Drug Administration but are tied up in ongoing patent litigation.
AbbVie's chief Gonzalez maintains a relatively sanguine view of biosimilar competition to Humira, underscoring his confidence in AbbVie's strategy on the July 28 call with analysts.
He specifically noted that nothing has fundamentally changed in AbbVie's negotiation with payers for next year as it relates to formulary access or the structure of that access. Biosimilars are expected to be attractive to cost-conscious payers looking to save but so far the discounts seen on launched biosimilars in the U.S. has been modest at best.
Finding success with upadacitinib and risankizumab — with regulatory submission planned next year for the former — will enable AbbVie to cover more patients and compete even in a tightening marketplace, Gonzalez said. Analysts voiced some concern about upadacitinib's safety profile given Eli Lilly's struggles with a drug of the same JAK1 class, baricitinib. However, AbbVie executives said they reviewed upadacitnib's data in light of the FDA's rejection of baricitinib and found no increased signal of deep vein thrombosis or pulmonary embolism — the two apparent concerns with baricitinib.
Strong performance from top cancer drug Imbruvica further boosted overall revenue growth, helping to offset a sharp 46% decline from AbbVie's hepatitis C treatment Viekira. AbbVie hopes expected data read outs from trials testing Venclexta (venetoclax) and its experimental lung cancer drug rova-T will add further momentum behind its oncology business.
A leading immunology portfolio and growing oncology business has AbbVie feeling confident it won't need major M&A to drive future growth. Gonzalez said Friday he doesn't see a lot of opportunities that fit the company's strategic objectives and will look more for individual assets to fill out portfolios rather than major platform adds.