List of Excipients in Branded Drug YUSIMRY

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YUSIMRY Excipient Strategy and Commercial Opportunities

Last updated: October 18, 2026

YUSIMRY (adalimumab-aqvh) is Coherus BioSciences’ biosimilar to Humira (adalimumab). Its commercial position depends less on novel excipient intellectual property than on formulation reliability, supply economics, device usability, payer access and contracting. YUSIMRY is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriasis and hidradenitis suppurativa. It was approved in October 2022 and launched in the United States in 2023. [1][2]

The formulation uses a conventional protein-stabilization system centered on mannitol and polysorbate 80 in water for injection. This profile supports a relatively simple excipient supply chain, but it limits opportunities to claim composition-of-matter protection. The stronger commercial opportunities are in high-concentration reformulation, citrate-free or low-volume delivery, autoinjectors, pediatric presentations, regional licensing and manufacturing-cost reduction.

What excipients are used in YUSIMRY?

YUSIMRY is supplied as a sterile, preservative-free solution of adalimumab-aqvh for subcutaneous injection. The FDA prescribing information identifies mannitol, polysorbate 80 and water for injection as inactive ingredients. [1]

Component	Function in YUSIMRY	Commercial relevance
Mannitol	Tonicity adjustment and protein-stability support	Widely available, low-cost excipient with established parenteral use
Polysorbate 80	Limits protein adsorption and aggregation at air-liquid and container surfaces	Critical quality attribute; oxidation and degradation must be controlled
Water for injection	Vehicle	Standard sterile injectable component
Adalimumab-aqvh	Active monoclonal antibody	Requires control of aggregation, particulates, potency and immunogenicity

YUSIMRY is a 40 mg/0.8 mL presentation, corresponding to a 50 mg/mL concentration. The product is supplied in a single-dose prefilled syringe. [1] The lower concentration and larger injection volume distinguish it from the high-concentration 40 mg/0.4 mL Humira presentation.

Does YUSIMRY contain citrate?

The FDA label identifies mannitol and polysorbate 80 among YUSIMRY’s inactive ingredients and does not list citrate as an inactive ingredient. [1] This is commercially relevant because citrate-containing adalimumab formulations were associated with injection-site discomfort, while later Humira formulations were marketed as citrate-free. YUSIMRY’s excipient profile can therefore support a patient-comfort message, although the product is not automatically interchangeable with every citrate-free adalimumab presentation.

How does the YUSIMRY formulation compare with Humira?

YUSIMRY was developed to be highly similar to Humira, but biosimilarity does not require identical inactive ingredients. FDA approval was based on analytical, nonclinical and clinical evidence showing no clinically meaningful differences from the reference product. [1][3]

Attribute	YUSIMRY	Humira high-concentration presentation
Active ingredient	Adalimumab-aqvh	Adalimumab
FDA pathway	Biosimilar	Reference biologic
Typical strength	40 mg/0.8 mL, 50 mg/mL	40 mg/0.4 mL, 100 mg/mL
Primary excipient strategy	Mannitol and polysorbate 80 in water for injection	Formulation varies by presentation and manufacturing version
Delivery	Single-dose prefilled syringe	Prefilled syringe, pen and other presentations
Interchangeability	Not designated interchangeable by FDA	Reference product
Patent status	No Orange Book listing	Humira patent estate and settlement history affected launch timing

The practical difference is injection volume. YUSIMRY’s 0.8 mL dose is twice the volume of Humira’s 0.4 mL high-concentration dose. That can affect patient preference, device development and competitive positioning. A future YUSIMRY reformulation at 100 mg/mL could reduce this disadvantage, but it would require additional analytical, stability, device and regulatory work.

What formulation opportunities exist for YUSIMRY?

The most valuable formulation opportunities are not likely to arise from adding a novel excipient. They are more likely to come from improving the interaction between the antibody, excipient system and delivery device.

High-concentration adalimumab

A high-concentration YUSIMRY formulation could provide:

• A 40 mg dose in approximately 0.4 mL.
• Reduced injection burden.
• Better positioning against Humira citrate-free 100 mg/mL products.
• Greater suitability for autoinjector delivery.
• Potential differentiation in specialty-pharmacy formularies.

The technical challenge is maintaining protein stability at higher concentration. Increasing antibody concentration can raise viscosity, aggregation risk, opalescence and injection force. Changes in mannitol or surfactant levels may affect osmolality, subvisible particles and long-term stability. A new strength could also require a supplemental FDA submission and device-specific human-factors work.

Alternative surfactant systems

Polysorbate 80 is established and inexpensive, but it has known degradation pathways, including hydrolysis and oxidation. Degradation can generate fatty acids, increase particles and affect protein stability. [4] Commercial development could evaluate:

• Polysorbate 20.
• Poloxamers.
• Low-peroxide surfactant grades.
• Stabilized or tightly controlled polysorbate 80.
• Surfactant-free formulations where feasible.

The business value would depend on measurable gains in shelf life, shipping robustness, particulate control or compatibility with a high-concentration formulation. A surfactant substitution without a patient or manufacturing benefit would have limited commercial value.

Buffer and pH optimization

YUSIMRY’s current inactive-ingredient disclosure does not identify a conventional buffer as a principal excipient. A future formulation could evaluate histidine, phosphate, acetate or other buffering systems. Buffer changes can affect:

• Deamidation and oxidation.
• Aggregation.
• Injection-site tolerability.
• Container closure compatibility.
• Freeze-thaw and temperature-excursion stability.

The strongest patent strategy would claim a defined combination of adalimumab concentration, pH range, excipient concentration, container and stability performance. A broad claim to mannitol plus polysorbate 80 would face significant prior-art and obviousness exposure.

Lyophilized or alternative dosage forms

A lyophilized YUSIMRY presentation could improve storage stability but would add reconstitution steps, manufacturing cost and administration complexity. It would be less competitive with ready-to-use prefilled syringes and autoinjectors.

Other possibilities include:

• Wearable or on-body delivery for larger-volume doses.
• Dual-chamber systems.
• Prefilled cartridges.
• Room-temperature-stable products.
• Pediatric low-dose presentations.

The commercial priority is likely a ready-to-use, low-volume, high-concentration product rather than a lyophilized product.

What patents protect YUSIMRY’s excipient strategy?

YUSIMRY’s core commercial protection does not come from an Orange Book patent estate. Biologics are recorded in the FDA Purple Book rather than the Orange Book, and YUSIMRY is not an FDA-designated interchangeable biosimilar. [3][5]

The relevant intellectual-property categories are:

IP category	Relevance to YUSIMRY	Likely strength
Adalimumab composition patents	Primarily held by the Humira reference-product owner; generally expired or commercially exhausted in the U.S. before YUSIMRY launch	Low for YUSIMRY
Biosimilar manufacturing patents	Cell line, culture, purification and process-control claims	Potentially moderate to strong if narrowly enabled
Formulation patents	Concentration, pH, surfactant, stabilizer and stability claims	Moderate if supported by unexpected performance
Device patents	Syringe, autoinjector, needle shield and delivery mechanics	Moderate to strong depending on ownership
Use patents	Indications and dosing regimens	Relevant to labeling and litigation
Trade secrets	Cell culture parameters, purification conditions and analytical controls	Potentially strong but not publicly visible

A formulation patent covering standard mannitol and polysorbate 80 concentrations would face prior-art risk because those excipients are common in antibody formulations. A more defensible claim would combine specific concentration ranges with demonstrated technical effects, such as reduced aggregation after thermal stress, improved syringe stability or lower injection force.

What is the FDA regulatory status of YUSIMRY?

YUSIMRY received FDA approval under the biosimilar pathway in section 351(k) of the Public Health Service Act. [1] The approved product is indicated for:

• Rheumatoid arthritis.
• Juvenile idiopathic arthritis.
• Psoriatic arthritis.
• Ankylosing spondylitis.
• Crohn’s disease.
• Ulcerative colitis.
• Plaque psoriasis.
• Hidradenitis suppurativa.
• Uveitis.

The product was approved as biosimilar to Humira but not as interchangeable. Under U.S. law, non-interchangeable biosimilars may still be prescribed and dispensed according to state substitution rules, but they do not receive the same automatic-substitution designation as an interchangeable product.

Does YUSIMRY have an Orange Book listing?

No. YUSIMRY is a biologic and is tracked through FDA’s Purple Book rather than the Orange Book. The Orange Book is principally used for approved small-molecule drugs and related patent and exclusivity information. Biosimilar reference-product disputes are handled through the Biologics Price Competition and Innovation Act framework, including patent-information exchanges and litigation under the patent-dispute process. [3][5]

When did YUSIMRY lose exclusivity, and when can generics launch?

YUSIMRY does not have traditional small-molecule generic exclusivity. Its market entry was governed by the Humira patent settlement landscape and the statutory biosimilar framework.

Milestone	Date or status
Humira U.S. approval	2002
YUSIMRY FDA approval	October 2022
U.S. commercial launch	2023
Biosimilar designation	Yes
Interchangeable designation	No
Small-molecule generic exclusivity	Not applicable
Biosimilar substitution	Governed by FDA designation and state law
Humira patent litigation	Resolved through manufacturer-specific settlements and launch licenses

YUSIMRY entered after the U.S. launch date permitted under Coherus’ settlement arrangements with AbbVie. AbbVie reached separate settlement agreements with multiple adalimumab biosimilar developers, producing staggered launch dates during 2023. [6][7]

Which companies compete with YUSIMRY?

YUSIMRY competes in a crowded U.S. adalimumab biosimilar market. Major competitors include:

• Amjevita, marketed by Amgen.
• Cyltezo, marketed by Boehringer Ingelheim.
• Hyrimoz, marketed by Sandoz.
• Hadlima, marketed by Organon and Samsung Bioepis.
• Abrilada, marketed by Pfizer.
• Simlandi, marketed by Teva and Alvotech.
• Idacio, marketed by Fresenius Kabi.
• Hulio, marketed by Biocon Biologics.
• Adalimumab-adbm and other approved products.

The competitive variable is not only price. Products compete on:

• WAC and net price.
• Interchangeability.
• High-concentration dosing.
• Autoinjector design.
• Payer formulary placement.
• Specialty-pharmacy distribution.
• Patient-support services.
• Manufacturing reliability.
• Indication breadth.
• Contracting with integrated delivery networks.

Cyltezo received FDA interchangeable designation, giving it a regulatory distinction that YUSIMRY does not currently have. [8] That distinction can affect pharmacy substitution and payer policy, particularly where formularies favor automatic substitution.

What commercial opportunities exist for YUSIMRY excipients?

Can excipient suppliers create value?

Yes, but the opportunity is primarily operational and formulation-driven. Potential supplier value includes:

1. Low-peroxide polysorbate 80 grades with tighter oxidation controls.
2. Pharmaceutical-grade mannitol with controlled particle and endotoxin profiles.
3. Excipient packages qualified for high-concentration monoclonal antibodies.
4. Single-use manufacturing components with lower leachable risk.
5. Stabilizer systems that support longer room-temperature excursions.
6. Analytical methods for surfactant degradation and particulate monitoring.

The supplier with the strongest position will not necessarily offer the lowest unit price. Qualification history, global regulatory documentation, lot consistency and supply continuity are important because switching excipients in a commercial biologic can require comparability work and regulatory review.

What licensing opportunities exist?

Potential licensing targets include:

• High-concentration adalimumab formulations.
• Autoinjector and wearable delivery systems.
• Interchangeable biosimilar development rights.
• Regional commercialization rights.
• Contract manufacturing in Europe, Asia or Latin America.
• Pediatric and low-dose presentations.
• Room-temperature-stable formulations.
• Formulation analytics and comparability platforms.

Coherus has used commercial partnerships and channel arrangements to expand access to its biosimilar portfolio. Its partnership with Mark Cuban Cost Plus Drug Company placed YUSIMRY within a low-cost distribution model, demonstrating that distribution economics can be as important as excipient differentiation. [9]

What manufacturing and IP barriers affect YUSIMRY?

The main barriers are not the cost of mannitol or polysorbate 80. They are:

• Mammalian cell-culture productivity.
• Viral clearance validation.
• Aggregate and particle control.
• Batch-to-batch similarity.
• Cold-chain distribution.
• Device assembly.
• Fill-finish capacity.
• Biosimilarity analytics.
• Immunogenicity monitoring.
• Regulatory comparability for formulation changes.

A reformulation can create a new patent opportunity but also introduce regulatory risk. Changes to concentration, excipient grade, surfactant level, container closure or delivery device may require new comparability studies. The commercial case must show that the change improves price realization, adherence, substitution, shelf life or manufacturing cost.

How strong is the YUSIMRY patent estate?

YUSIMRY’s excipient patent estate is likely weaker than its manufacturing know-how and commercial contracting position. Standard excipients are difficult to protect broadly. The strongest defensible assets would be:

• A high-concentration formulation with demonstrated stability.
• A low-volume delivery system.
• A formulation-device combination.
• A process that improves yield or reduces aggregate formation.
• A manufacturing method with measurable cost or quality benefits.
• A stability package that supports less restrictive distribution.

The weakest strategy would be a narrow patent directed only to conventional mannitol and polysorbate 80 use without unexpected results.

What generic launch risks exist for YUSIMRY?

YUSIMRY faces biosimilar competition rather than traditional generic competition. Key risks include:

Risk	Impact
Interchangeable competitors	May reduce prescribing friction and improve automatic substitution
High-concentration competitors	May make YUSIMRY’s 0.8 mL presentation less attractive
Payer consolidation	Can compress net price and favor a limited number of suppliers
Price erosion	Reduces return on formulation and manufacturing investment
Supply disruptions	Can cause formulary displacement
Device differentiation	Can shift prescriber and patient preference
New indications or label changes	Can alter contracting value across specialties
International price controls	Limit regional licensing returns

Key Takeaways

• YUSIMRY is a 50 mg/mL adalimumab biosimilar supplied as 40 mg/0.8 mL.
• Its listed excipients are mannitol, polysorbate 80 and water for injection.
• The formulation is commercially practical but offers limited broad composition-of-matter patent potential.
• The largest formulation opportunity is a 100 mg/mL, low-volume, patient-friendly presentation.
• Polysorbate degradation, aggregation, viscosity and injection force are the main technical issues for reformulation.
• YUSIMRY is tracked in the Purple Book, not the Orange Book.
• It is FDA-approved as a biosimilar but not designated interchangeable.
• Commercial performance depends on payer contracts, price, supply continuity, device usability and distribution.
• Manufacturing know-how and device rights may be more valuable than conventional excipient patents.
• Formulation licensing, high-concentration development and low-cost regional manufacturing are the most credible commercial opportunities.

FAQs

Is YUSIMRY citrate-free?

The FDA label identifies mannitol and polysorbate 80 as inactive ingredients and does not list citrate. [1]

Can YUSIMRY be automatically substituted for Humira?

YUSIMRY is not FDA-designated interchangeable. Substitution depends on state law, payer policy and pharmacy practice.

Is YUSIMRY a generic drug?

No. YUSIMRY is a biologic biosimilar, not a traditional small-molecule generic.

Could YUSIMRY be reformulated at 100 mg/mL?

Yes, but the program would require formulation, stability, device, comparability and regulatory work. Higher concentration can increase viscosity, aggregation and injection force.

Which excipient is the largest technical risk in YUSIMRY?

Polysorbate 80 is the principal excipient risk because oxidation and hydrolysis can produce degradation products and contribute to particle formation. Mannitol is generally lower risk but still requires control of grade, purity and tonicity.

References

1. U.S. Food and Drug Administration. (2022). YUSIMRY (adalimumab-aqvh) injection, prescribing information.
2. Coherus BioSciences, Inc. (2023). Coherus announces U.S. launch of YUSIMRY, an interchangeable? [Commercial release concerning YUSIMRY launch].
3. U.S. Food and Drug Administration. (2023). Purple Book: Lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations.
4. Kerwin, B. A. (2008). Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: Structure and degradation pathways. Journal of Pharmaceutical Sciences, 97(8), 2924-2935.
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
6. AbbVie Inc. (2023). Humira patent settlement and biosimilar launch agreements.
7. U.S. Food and Drug Administration. (2023). FDA-approved adalimumab biosimilar products.
8. U.S. Food and Drug Administration. (2019). Cyltezo (adalimumab-adbm) approval and interchangeability designation.
9. Mark Cuban Cost Plus Drug Company. (2023). YUSIMRY distribution and pricing announcement.