MNC Autoimmune Race Heats Up: Lilly Challenges Dupilumab with Lebrikizumab as J&J Counters Stelara Patent Cliff with Tremfya

Since its launch in September 2009, Stelara has been approved for multiple indications, including moderate to severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderate to severe Crohn's disease (CD), and moderately to severely active ulcerative colitis (UC) in adult patients. As a core product of Johnson & Johnson in the field of autoimmune diseases, this drug generated nearly 10 billion US dollars in sales in 2021 and 2022, and exceeded the 10-billion-dollar mark in 2023, becoming the strongest product in Johnson & Johnson’s sales portfolio.

WithStelaraThe patent will expire in 2023, as of now.Global Layout of 18 Stelara Biosimilars, Six ApprovedAmong them, Samsung Bioepis' biosimilar Pyzchiva, which received regulatory approval in April, will fully compete with Stelara in psoriatic arthritis, Crohn's disease, and ulcerative colitis. Additionally, Amgen plans to launch a series of Stelara biosimilars in 2025. Following this, the price discounts under the Inflation Reduction Act (IRA) will take effect. Stelara has been selected as one of the ten drugs eligible for Medicare price negotiations and will face price reductions in 2026.

Intense competition soon reflected in the financial report data, with Stelara's sales reaching nearly $2.7 billion in the third quarter of this year, marking a 6.6% decrease compared to the same period in 2023.

And subsequent innovator drug challengers have also stepped up their efforts: Recently, Eli Lilly announced the results of its monoclonal antibody Omvoh in a Phase 3 trial named VIVID-1. During the 52-week follow-up, more patients using Eli Lilly's Omvoh showed histological response, and the one-year histological response in Crohn's disease patients was superior to Johnson & Johnson's blockbuster drug Stelara.

Johnson & Johnson's head of innovative medicines, Jennifer Taubert, said in a conference call that Tremfya would be positioned as the successor product to "outperform Stelara."

And in just the past September, Johnson & Johnson announced that the FDA had approved Tremfya (Guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), becomingThe First and OnlyDual-mechanism interleukin-23 (IL-23) inhibitor approved for the treatment of active ulcerative colitis. This approval by the U.S. FDA marks the third indication for Tremfya.

• Tremfya was first approved by the FDA in July 2017 for the treatment of adult patients with moderate to severe plaque psoriasis.

• Approved in July 2020 for the treatment of adult patients with active psoriatic arthritis.

Since its launch, Tremfya's sales have continued to grow, reaching $3.146 billion in 2023 (+18%), with sales in the first three quarters of this year amounting to $2.721 billion (+21.6%). Meanwhile, according to Johnson & Johnson CEO Joaquin Duato during the company’s Q1 earnings call in April,Tremfya’s sales in its approved indications of plaque psoriasis and psoriatic arthritis have now surpassed those of Stelara.

Whether Tremfya can become a new pillar in Johnson & Johnson's autoimmune field in the future, Pharma Hunters will continue to follow.

According to Lilly's disclosure, Ebglyss™ (lebrikizumab-lbkz) in the Phase 3b ADapt studyShow improvement in skin (including hands and face) and itching symptoms in patients with moderate to severe atopic dermatitis (eczema) who had previously been treated with Regeneron and Sanofi's immunology blockbuster drug Dupilumab (Dupixent).

At week 16, 57% of patients who had previously received dupilumab and were using EBGLYSS achieved EASI-75. By week 24, this proportion increased to 60%.. These results are similar to those observed in the EBGLYSS Phase 3 monotherapy trials (ADvocate 1 and ADvocate 2) conducted in patients who had not previously been exposed to dupilumab. Additionally, 46% of patients who had an inadequate response to dupilumab achieved an EASI-75 response by week 16 after using EBGLYSS.

Mark Genovese, M.D., Senior Vice President of Immunology Development at Eli Lilly, stated: "This trial demonstrates that healthcare providers can confidently prescribe EBGLYSS as a first-line biologic treatment for moderate-to-severe atopic dermatitis, and EBGLYSS offers meaningful benefits for individuals whose disease has been difficult to treat despite trying another biologic therapy such as dupilumab."

And just in September, the U.S. FDA approved the IL-13 inhibitor Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older, weighing at least 40 kg) with moderate to severe atopic dermatitis (AD) whose condition is not adequately controlled despite the use of topical medications.

Notably, in 2022, Eli Lilly received a Complete Response Letter from the FDA. The reason was not related to the drug's safety or labeling issues but rather due to compliance concerns involving a third-party manufacturer. After a year of corrective actions, Eli Lilly successfully resolved the manufacturing issues and eventually obtained formal approval from the FDA.

Ebglyss Launches a New Treatment Option for Moderate to Severe Eczema Patients

In addition, Ebglyss, as the new star among Eli Lilly's four launched autoimmune products, will directly compete with the leading product Dupixent in a highly competitive market.

Dupixent, a monoclonal antibody targeting the shared receptor subunit alpha (IL-4Rα) of interleukin-4 (IL-4) and interleukin-13 (IL-13), was co-developed by Sanofi and Regeneron. Since its approval by the U.S. FDA on March 28, 2017, Dupixent has been authorized for use in numerous countries worldwide to treat: 1) Moderate-to-severe atopic dermatitis (AD): Suitable for patients aged 6 months and older, especially when topical therapies fail to adequately control symptoms or are not applicable; 2) Moderate-to-severe prurigo nodularis (PN): Applicable to adult patients, particularly those requiring systemic treatment; 3) Asthma: Indicated for adolescents aged 12 years and older as well as adults, especially those with poorly controlled asthma despite the use of medium-to-high doses of inhaled corticosteroids (ICS) and other asthma control medications, and those dependent on oral corticosteroids.

Dupixent's sales reached $11.57 billion in 2023, and it is expected to reach €13 billion (approximately $14 billion) in 2024.

References

Company Official Website, Orient Securities, Antibody Key

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