Johnson & Johnson’s Strategic Pivot in the Autoimmune Space: Navigating Patent Cliffs and Clinical Setbacks

Johnson & Johnson (J&J) faces a pivotal moment in its autoimmune portfolio as the erosion of revenue from Humira and Stelara accelerates. The expiration of Humira’s U.S. patent in 2023 triggered an immediate 34% revenue drop, with sales projected to fall to $9 billion in 2024 as biosimilars capture market share [1]. Stelara, another cornerstone, has seen a 33.7% year-over-year sales decline in Q1 2025 due to seven ustekinumab biosimilars entering the market [2]. These patent cliffs, compounded by the Inflation Reduction Act’s 66% price cut for Stelara in 2026, underscore the urgency for J&J to pivot its strategy.

The company’s response has been twofold: litigation to delay biosimilar entry and investment in next-generation therapies. Preemptive lawsuits against biosimilar manufacturers temporarily slowed competition for Stelara [2], but the long-term solution lies in innovation. J&J’s pipeline includes promising candidates like Imaavy (nipocalimab-aahu), recently FDA-approved for generalized myasthenia gravis (gMG), and Icotrokinra, an oral IL-23 inhibitor in phase 3 trials for ulcerative colitis [3]. These therapies aim to fill gaps left by declining biologics and address unmet needs in rare autoimmune conditions.

However, J&J’s path is not without hurdles. Clinical setbacks, such as the discontinuation of aticaprant for major depressive disorder and a failed arthritis combination therapy involving nipocalimab, highlight the risks of high-stakes R&D [4]. Additionally, the global immunology drug market, while growing at a 9.41% CAGR through 2030 [5], remains fiercely competitive. Biosimilars have already demonstrated cost advantages, with Navitus Health Solutions reporting 85% net savings per claim for ustekinumab biosimilars in 2025 [5].

J&J’s long-term viability hinges on its ability to balance innovation with resilience. While Imaavy’s approval and Icotrokinra’s phase 3 progress signal optimism, the company must navigate regulatory shifts, pricing pressures, and the shadow of past failures. The FDA’s potential rule changes to deem all biosimilars interchangeable could further erode J&J’s market share, even as its pipeline advances.

In conclusion, J&J’s strategic pivot reflects a blend of defensive and offensive moves. The autoimmune space remains lucrative, but sustaining growth will require not only successful drug launches but also navigating a landscape where patent cliffs and clinical risks are inevitable. Investors must weigh J&J’s pipeline strengths against its recent setbacks to assess whether the company can reclaim its position as a leader in immunology.

Source:
[1] The End of an Era: As Blockbusters Fizzle, How Biotech's [https://www.drugpatentwatch.com/blog/as-blockbuster-drugs-fizzle-biotech-looks-warily-to-the-next-big-thing/?srsltid=AfmBOoqzjY3s7HIEN22U36EId2SBDIZYRIE9jFHFJs2ed9cRyGo0vbPq]
[2] Apples to apples: Stelara biosimilars and the fight for market share [https://www.biopharmadive.com/spons/apples-to-apples-stelara-biosimilars-and-the-fight-for-market-share/753098/]
[3] Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu) [https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-approval-for-imaavytm-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg]
[4] J&J drops Phase III MDD programme due to lack of efficacy [https://www.clinicaltrialsarena.com/news/johnson-johnson-mdd-trial-failure-termination/]
[5] Top 20 Immunology Drugs Market Analysis And Segment [https://www.grandviewresearch.com/market-trends/top-20-immunology-drugs-market]