AbbVie’s Humira loss of exclusivity a missed opportunity for competitors: GlobalData

AbbVie‘s market leadership, driven by its flagship disease-modifying antirheumatic drug Humira (adalimumab), faced a significant test with the 2023 loss of patent protection. Despite an anticipated competitive surge, rivals have struggled to capitalise. AbbVie’s strategic shift to Skyrizi (risankizumab) and Rinvoq (upadacitinib) has solidified its position, underscoring a missed opportunity for competitors in the immunology market, says GlobalData.

AbbVie has maintained a strong position within the immunology space for the past few years, largely due to the success of its anti-tumor necrosis factor (TNF) inhibitor, Humira. On December 31, 2002, the drug received its first FDA approval to treat rheumatoid arthritis in adult patients and saw $246 million in US sales the following year on market.

In subsequent years, the strength of this asset has only grown with its expansion into additional diseases, with annual US sales peaking in 2022 at $18.6 billion. However, with the loss of patent protection in the US at the start of 2023, and the ensuing flood of adalimumab biosimilars to the market, AbbVie has faced a decline in sales of Humira, indicated by a 39.9 per cent decrease in the first-quarter year-over-year US Humira revenue in 2024, which has been attributed to biosimilar competition.

Adeleke Badejo, Managing Analyst – Immunology at GlobalData, states, “This scenario once viewed as an opening for competitors to knock AbbVie off its throne, now is seen as a lost opportunity. AbbVie utilised a two-prong approach towards Humira, with the anti-interleukin (IL)-23 inhibitor biologic, Skyrizi (risankizumab), and the Janus kinase inhibitor (JAKi), Rinvoq (upadacitinib).”

“This was a unique strategy, as other competitors typically focus on positioning a signal asset as the next generation offering. Upadacitinib as the second candidate is of note due to the general safety concerns associated with the JAKi drug class at the time. With these two therapies, AbbVie has followed Humira’s gameplay of targeting multiple common disease, such as inflammatory bowel disease, and psoriasis,” adds Badejo.

Throughout AbbVie’s retooling process, its stiffest challenge has been within the evolving IL-23 drug class, as the only JAKi of note in recent years has been BMS’ Sotyktu (deucravacitinib), and though Sotyktu has been approved to treat psoriasis, trial failures in ulcerative colitis (UC) and Crohn’s disease (CD) have reduced the therapy’s potential as a blockbuster or challenger. However, with the development of IL-23, AbbVie has been directly challenged by competitor assets, Lilly’s Omvoh (mirikizumab) and Janssen’s Tremfya (guselkumab).

Tremfya was the first of the three to reach the market with plaque psoriasis approval in the US in July 2017 (Nov 2017 EU). This was followed by Skyrizi in April 2019, and recently, Omvoh which was approved to treat UC in May (EU) and October 2023 (US).

Badejo continues, “Once seen as a three-horse race, the IL-23 market is now led by AbbVie’s Skyrizi, exemplified by its four approved indications compared only to two for Tremfya. The failure of Omvoh to show superiority over the older, anti-IL-23/12 therapy, Janssen’s Stelara, has only bolstered AbbVie standing.”

In addition to navigating past loss of Humira exclusivity and maintaining its place within the market, recent acquisitions indicate AbbVie’s intention to only strengthen its position within immunology.

On June 13,  2024, AbbVie announced a licence agreement with FutureGen to develop FG-M701, a TNF-like cytokine 1A (TL1A). TL1A has garnered significant attention after the substantial acquisition price for these assets seen last year, $10.3 billion by Merck, $7.1 billion by Roche, and $1.5 billion by Sanofi. The upfront cost of $150 million by AbbVie could be seen as measured in comparison.

AbbVie also announced on June 27, 2024 the acquisition of Celsius Therapeutics, and notably CEL383, an anti-triggering receptor expressed on myeloid cells 1 (TREM1) antibody that has completed a Phase 1 clinical study for the treatment of IBD, for $250 million.

​“The recent reports, such as Boehringer Ingelheim plans on reducing the safesforce due to poor sales of its adalimumab biosimilar, and the sale of Coherus BioSciences’ Humira biosimilar for only $40 million, indicate that the adalimumab market may not be as promising as anticipated,” Badejo concludes.