Last updated: September 8, 2026
Brodalumab is a commercially constrained IL-17 receptor A biologic for moderate-to-severe plaque psoriasis. Its clinical profile is competitive with other IL-17 inhibitors, but the product has remained a niche asset because of its early suicidality warning, restricted distribution history, limited label breadth, and stronger commercial execution by competitors such as Cosentyx, Taltz, Tremfya, Skyrizi and Bimzelx.
Brodalumab revenue is not separately disclosed by its principal commercial partners. Public filings indicate a small, non-core contribution relative to the leading psoriasis biologics. U.S. reference-product exclusivity is scheduled to run through February 2030 under the Biologics Price Competition and Innovation Act, based on the February 2017 FDA approval date. Commercial erosion risk is more likely to come from branded competition and formulary pressure before broad biosimilar substitution becomes material.
What is brodalumab and how is it positioned commercially?
Brodalumab is a fully human monoclonal antibody that blocks interleukin-17 receptor A, or IL-17RA. This mechanism inhibits signaling from several IL-17 cytokines, including IL-17A, IL-17F and IL-17C pathways.
| Attribute |
Brodalumab |
| U.S. brand |
Siliq |
| European brand |
Kyntheum |
| Japanese brand |
Lumicef |
| Active ingredient |
Brodalumab |
| Mechanism |
Selective IL-17 receptor A inhibition |
| U.S. sponsor |
Bausch Health / Ortho Dermatologics |
| European commercial partner |
LEO Pharma |
| Japanese commercial partner |
Kyowa Kirin |
| U.S. approval |
February 15, 2017 |
| U.S. indication |
Adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy |
| Dose |
210 mg subcutaneously at weeks 0, 1 and 2, then every two weeks |
| Administration |
Prefilled syringe |
| U.S. regulatory status |
Approved biologic with a boxed warning and postmarketing safety controls |
Brodalumab’s main clinical advantage is broad IL-17RA pathway inhibition and a rapid psoriasis response profile. Its commercial limitation is that the product competes in a crowded class where physicians have multiple alternatives without the same historical safety burden.
How did brodalumab reach the market?
Brodalumab was originally developed by Amgen and later advanced through an alliance with AstraZeneca. Amgen terminated its involvement in 2015 after reports of suicidal ideation and behavior in clinical-trial participants. AstraZeneca retained development rights and entered into a commercial arrangement with Valeant Pharmaceuticals, whose dermatology business later became part of Bausch Health.
The principal transactions were:
| Period |
Corporate event |
Commercial effect |
| Pre-2015 |
Amgen and AstraZeneca development collaboration |
Brodalumab advanced through late-stage psoriasis trials |
| 2015 |
Amgen exited the collaboration |
AstraZeneca retained the asset |
| 2015-2016 |
AstraZeneca and Valeant commercial arrangement |
Valeant obtained rights in the U.S. and Canada |
| 2016 |
AstraZeneca transferred European commercial rights to LEO Pharma |
LEO Pharma assumed European commercialization |
| 2017 |
FDA approved Siliq |
U.S. launch began under a restricted safety framework |
| 2017 onward |
Kyowa Kirin commercialized Lumicef in Japan |
Japan became a separate regional revenue stream |
Bausch Health subsequently marketed brodalumab through Ortho Dermatologics in the United States. AstraZeneca no longer reports brodalumab as a major commercial product.
What is the FDA regulatory status of Siliq?
The FDA approved Siliq in February 2017 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond to other systemic treatments.
The approval included a boxed warning for suicidal ideation and behavior. The FDA also required a Risk Evaluation and Mitigation Strategy, or REMS, that controlled prescribing and dispensing. The original commercial framework required prescribers and pharmacies to participate in the program and required patients to receive safety information.
The safety controls materially affected market adoption. Dermatologists had other IL-17 and IL-23 inhibitors available without the same prescribing restrictions, reducing the incentive to initiate brodalumab in patients who could receive alternative therapy.
The FDA later removed the Siliq REMS requirement after reviewing postmarketing safety data, while the boxed warning remained in the product labeling. The removal reduced administrative friction but did not fully eliminate the commercial effect of the warning.
What does the Siliq label limit?
Siliq is approved only for adult plaque psoriasis. It is not broadly positioned across psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa or inflammatory bowel disease.
The label includes:
- A boxed warning for suicidal ideation and behavior.
- A requirement to assess patients for depression and suicidal thoughts.
- A contraindication in patients with Crohn’s disease.
- Infection warnings associated with IL-17 pathway inhibition.
- A requirement for tuberculosis evaluation before treatment.
- Restrictions related to inflammatory bowel disease risk.
The narrow label contrasts with competitors that have expanded into psoriatic arthritis, ankylosing spondylitis, Crohn’s disease or other immune-mediated disorders.
How large is the brodalumab market?
Brodalumab operates in a global plaque-psoriasis biologic market dominated by IL-23 and established IL-17 therapies. The U.S. market has shifted toward products with durable dosing, strong payer positioning and multiple approved indications.
Competitive comparison
| Product |
Mechanism |
Principal sponsor |
Commercial position |
| Siliq |
IL-17RA inhibitor |
Bausch Health |
Niche psoriasis product |
| Cosentyx |
IL-17A inhibitor |
Novartis |
Large multi-indication franchise |
| Taltz |
IL-17A inhibitor |
Eli Lilly |
Large psoriasis and rheumatology franchise |
| Tremfya |
IL-23 inhibitor |
Johnson & Johnson |
Strong psoriasis and psoriatic arthritis growth |
| Skyrizi |
IL-23 inhibitor |
AbbVie |
Large multi-indication immunology franchise |
| Bimzelx |
IL-17A and IL-17F inhibitor |
UCB |
Newer high-efficacy competitor |
| Ilumya |
IL-23 inhibitor |
Sun Pharma |
Longer-interval psoriasis therapy |
| Otezla |
PDE-4 inhibitor |
Amgen |
Oral, non-biologic alternative |
Brodalumab’s clinical efficacy is not sufficient by itself to overcome the commercial disadvantages created by the warning history and limited indications. IL-23 inhibitors also offer less frequent maintenance dosing, which is attractive to patients, physicians and payers.
What is the financial trajectory of brodalumab?
Brodalumab’s financial trajectory is best characterized as a low-scale, stable-to-modest-growth dermatology asset rather than a major biologics franchise.
Bausch Health does not consistently report Siliq revenue as a standalone line item in public financial statements. It reports broader product categories and operating segments, which prevents a reliable company-confirmed annual sales series for Siliq. LEO Pharma and Kyowa Kirin also do not provide a complete, consistently comparable global brodalumab revenue disclosure.
The commercial trajectory has four phases:
| Phase |
Period |
Financial profile |
| Pre-launch |
2015-2016 |
Development value reduced by safety concerns and Amgen’s withdrawal |
| U.S. launch |
2017-2019 |
Slow uptake under boxed warning and REMS restrictions |
| Stabilization |
2020-2022 |
Continued niche use through specialty dermatology channels |
| Mature asset phase |
2023 onward |
Limited upside, with competition and future biologic substitution constraining growth |
Brodalumab’s revenue exposure is concentrated in specialty dermatology and is not strategically material to AstraZeneca. For Bausch Health, the product has greater portfolio relevance because it sits within the Ortho Dermatologics franchise, but it remains smaller than the company’s largest pharmaceutical businesses.
What factors could improve revenue?
Potential commercial supports include:
- Increased prescribing after REMS removal.
- Greater use in patients who fail or lose response to other biologics.
- Contracting that improves access relative to IL-17 and IL-23 competitors.
- Increased awareness of IL-17RA pathway coverage.
- Expansion into additional inflammatory diseases, if supported by clinical and regulatory data.
The strongest limitation is label breadth. Brodalumab lacks the multi-indication revenue base that allows leading biologics to absorb psoriasis pricing pressure.
When does brodalumab lose exclusivity?
The FDA approved Siliq on February 15, 2017. Under the BPCIA, an approved reference biologic receives 12 years of reference-product exclusivity, placing the statutory exclusivity endpoint in February 2029. A six-month pediatric extension does not appear to be a central commercial factor for Siliq because the product’s approved U.S. label is adult-focused.
A practical U.S. biosimilar launch date may occur after February 2029, subject to:
- Biosimilar approval timing.
- Patent litigation under the BPCIA.
- Any enforceable patent term extending beyond reference-product exclusivity.
- Commercial development decisions by biosimilar manufacturers.
- Interchangeability and payer adoption.
Reference-product exclusivity and patent expiry are separate concepts. Expiration of the 12-year statutory period does not automatically authorize a biosimilar to launch if enforceable patents remain.
What patents protect brodalumab?
Brodalumab is a biologic, so its U.S. patent position is not presented through the Orange Book in the same manner as small-molecule drugs. Biologic patent disputes generally rely on the BPCIA patent-exchange process and federal district-court litigation rather than the conventional Orange Book Paragraph IV framework.
Publicly identifiable brodalumab patent families cover:
- Anti-IL-17 receptor antibodies.
- Antibody sequence and binding characteristics.
- Use of brodalumab for psoriasis.
- Dosing and treatment methods.
- Production and cell-culture methods.
Representative U.S. patent families associated with brodalumab development include U.S. Patent Nos. 8,349,320 and 9,266,951, among other continuation and related family members. Publicly reported expiration windows for core antibody and use claims extend into the late 2020s and, for some family members, around 2030. Exact enforceability depends on claim scope, terminal disclaimers, patent-term adjustment and the relevant patent family member.
Does Siliq have Orange Book listings?
Siliq is approved under a biologics license application rather than a conventional new drug application. It therefore does not have a conventional Orange Book patent-listing profile comparable to a small-molecule product.
The relevant competitive-exclusivity sources are:
- BPCIA reference-product exclusivity.
- Patent families covering the antibody and its uses.
- Potential manufacturing and process patents.
- Litigation settlements or license agreements with biosimilar applicants.
Are there Paragraph IV challenges or biosimilar threats?
A conventional Paragraph IV challenge is not the standard pathway for brodalumab because Siliq is a biologic. A biosimilar applicant would generally proceed under the BPCIA, not through an ANDA Paragraph IV certification.
No major publicly reported U.S. brodalumab biosimilar launch or commercial challenge had materially altered the market through 2024. The near-term threat is therefore branded therapeutic substitution rather than immediate biosimilar erosion.
Potential biosimilar entrants would face a relatively small market opportunity. That reduces the incentive to incur development, manufacturing and litigation costs unless a sponsor can offer a substantial price discount or obtain a favorable interchangeability position.
What patent litigation and settlements affect brodalumab?
No major public U.S. patent litigation or settlement involving a commercial brodalumab biosimilar had become a defining market event through 2024.
This does not mean the product is litigation-free. Future disputes could involve:
- Antibody sequence claims.
- IL-17RA binding claims.
- Psoriasis treatment methods.
- Dosing schedules.
- Manufacturing processes.
- Patent-term calculations.
The limited revenue pool reduces the likelihood that brodalumab will attract the same volume of biosimilar litigation as high-revenue biologics such as Humira, Stelara or Enbrel.
What generic launch scenarios exist for brodalumab?
Three launch scenarios are commercially plausible.
Scenario 1: Delayed biosimilar entry
A biosimilar launches after February 2029 but remains limited because Siliq has modest market share and physicians continue to prefer larger franchises. Price erosion is gradual.
Scenario 2: One discounted biosimilar entrant
A single biosimilar uses a meaningful discount to win payer access. Siliq retains patients with established clinical response, but new-start volume shifts toward the lower-cost product.
Scenario 3: Multiple biosimilar entrants
Several manufacturers enter after regulatory and patent barriers clear. Net price declines accelerate, and Siliq becomes a retention-focused product with declining specialty-pharmacy volume.
The third scenario is less likely than for blockbuster biologics because the addressable commercial opportunity is smaller.
How does brodalumab compare with competing IL-17 drugs?
Brodalumab is differentiated pharmacologically through IL-17RA blockade, but its commercial position is weaker than products with broader labels and stronger safety familiarity.
| Factor |
Brodalumab |
Leading IL-17 or IL-23 competitors |
| Psoriasis efficacy |
Strong |
Strong |
| Dosing |
Every two weeks after loading |
Often every four to 12 weeks after loading |
| Label breadth |
Narrow |
Often includes psoriatic arthritis and other diseases |
| Safety perception |
Weighed down by suicidality warning |
Generally more familiar to prescribers |
| Distribution history |
REMS burden historically applied |
Usually simpler |
| Revenue scale |
Niche |
Several blockbuster franchises |
| Biosimilar exposure |
Later-stage risk |
Varies by product and patent estate |
The primary economic problem is not lack of efficacy. It is the lower expected lifetime value per patient relative to competitors that can retain patients across multiple indications.
What is the outlook for brodalumab revenue?
The base-case outlook is low growth followed by gradual erosion as the psoriasis market continues shifting toward IL-23 inhibitors and newer IL-17 products. Revenue can remain durable in patients who respond well, require an alternative mechanism, or face coverage restrictions for competing brands.
A material upward revision would require one of three developments:
- Label expansion into a large inflammatory disease.
- A major improvement in payer access.
- Evidence that changes physician perception of the historical suicidality concern.
Without one of those events, brodalumab is more likely to remain a defensible niche asset than become a high-growth immunology franchise.
Key Takeaways
- Brodalumab is marketed as Siliq in the U.S., Kyntheum in Europe and Lumicef in Japan.
- Bausch Health, LEO Pharma and Kyowa Kirin are the principal commercial organizations by region.
- The product’s U.S. approval date was February 15, 2017.
- BPCIA reference-product exclusivity runs to approximately February 2029.
- The product has no conventional Orange Book patent profile because it is a biologic.
- Publicly identified patents cover antibody structure, binding, treatment methods and manufacturing.
- No major publicly reported brodalumab biosimilar litigation or commercial launch had materially changed the market through 2024.
- Siliq revenue is not separately disclosed in a consistent public series.
- The commercial trajectory is niche and mature, with limited probability of major growth without label expansion.
- Competitive pressure from IL-23 biologics and newer IL-17 products is greater than near-term biosimilar pressure.
FAQs
Is brodalumab still commercially available?
Yes. Brodalumab remains marketed as Siliq in the United States, although its commercial scale is substantially smaller than leading psoriasis biologics.
Is Siliq a biosimilar or a reference biologic?
Siliq is the reference biologic approved by the FDA in 2017. It is not a biosimilar.
What is the main commercial risk for Siliq?
The main risk is therapeutic substitution by IL-23 and IL-17 competitors with broader labels, longer dosing intervals and fewer historical prescribing restrictions.
Does brodalumab have a patent beyond 2029?
Some patent-family members may extend into or beyond the late 2020s, but the effective launch date for a biosimilar depends on the specific claims, patent-term adjustments, litigation and settlement terms.
Who owns brodalumab?
No single company controls all global commercial rights. Bausch Health markets Siliq in the United States, LEO Pharma commercializes Kyntheum in Europe, and Kyowa Kirin markets Lumicef in Japan. AstraZeneca retains historical development relevance but is no longer the principal commercial operator.
References
-
AstraZeneca. (2016). AstraZeneca completes transaction with LEO Pharma for brodalumab rights in Europe. Company announcement.
-
Bausch Health Companies Inc. (2023). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.
-
Food and Drug Administration. (2017). FDA approves new treatment for moderate-to-severe plaque psoriasis. U.S. Department of Health and Human Services.
-
Food and Drug Administration. (2024). Siliq prescribing information. U.S. Department of Health and Human Services.
-
Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. U.S. Department of Health and Human Services.
-
LEO Pharma. (2016). LEO Pharma acquires European rights to brodalumab. Company announcement.
-
U.S. Congress. (2010). Patient Protection and Affordable Care Act, Title VII, Section 7002: Price competition for certain biological products. 42 U.S.C. § 262.
