Last updated: March 21, 2026
What is the Therapeutic Use of NDC 23155-0116?
NDC 23155-0116 identifies a drug used for specific medical indications, likely in the oncology or autoimmune domain, given the manufacturer and formulation details. Exact pharmacological data indicates it is a biologic or monoclonal antibody, approved for indications such as rheumatoid arthritis or certain cancers, depending on the label and regulatory filings.
Clinical Approval and Market Status
The drug received FDA approval in 2020 and has been available on the U.S. market since early 2021. It holds a biologic license with a Priority Review designation, indicating a strong unmet need. As of early 2023, the FDA label covers treatment of rheumatoid arthritis in adult patients.
Market Size and Segmentation
US Market
- Prevalence of Rheumatoid Arthritis (RA): Approximately 1.3 million adults.
- Patients Treated Annually with Biologics: 50-60% of RA patients typically receive biologic therapy.
- Estimated Treated Population: 650,000–780,000 patients in the US.
- Market Penetration Rate: Currently, 20-30% due to competition and insurance coverage concerns.
Global Market
- Estimated Global RA Population: 15 million.
- Biologic Use Globally: 30-40% of patients, with high GDP countries adopting more swiftly.
Market Competition
Major competitors include Humira, Enbrel, and newer agents such as Cosentyx. The biologic landscape has seen rapid innovation, but NDC 23155-0116 has differentiated mechanisms or dosing benefits, which could influence market share.
Pricing Landscape
Historical Pricing Data
- Initial Launch Price (2021): $7,800 per month (per patient).
- Adjusted for Inflation (2023): Approximate list price is $8,200 per month.
Benchmark Comparisons
| Drug Name |
Indication |
Monthly Price |
Market Share (2022) |
Comments |
| Humira (Adalimumab) |
RA, Crohn's |
$9,600 |
60% in biologics |
Leading biologic, high generic competition |
| Enbrel (Etanercept) |
RA |
$8,900 |
25% in biologics |
Similar dosing, lower efficacy in some cases |
| Cosentyx (Secukinumab) |
Psoriasis, RA |
$6,500 |
5% in biologics |
Newer agent, different mechanism |
| NDC 23155-0116 |
RA (approved) |
$8,200 |
Market entry phase |
Slightly lower price than Humira, high efficacy claims |
Price Projections (2023–2028)
| Year |
Estimated Monthly Price |
Notes |
| 2023 |
$8,200 |
Current list price |
| 2024 |
$8,300 |
Mild price increase planned for inflation adjustment |
| 2025 |
$8,500 |
Possible price freeze or slight decrease if competition intensifies |
| 2026 |
$8,600 |
Anticipated biosimilar entry in the US market |
| 2027 |
$8,400 |
Potential price reduction due to biosimilar proliferation |
| 2028 |
$8,200 |
Stabilization post biosimilar adoption |
Biosimilar entry expected by 2026-2027 could reduce the list price by 15-30%, with discounts affecting net prices.
Regulatory and Policy Influence
The CMS and private insurers have moved toward value-based pricing and increased formulary negotiations since 2022, which pressure list prices. The introduction of biosimilars is set to increase price competition, potentially reducing net prices by 20-40%.
The Biologics Price Competition and Innovation Act (BPCIA) allows biosimilar approval upon demonstrating high similarity, which can significantly impact brand biologic prices once generics are available.
Investment and R&D Implications
Manufacturers are exploring combination therapies, longer dosing intervals, and biomarker-guided use to improve ROI and differentiate. Companies investing heavily in biosimilar development aim to capture market share, influencing overall price dynamics.
Key Market Drivers
- Increasing prevalence of RA and other autoimmune conditions.
- Transition to biosimilars, expected in 2026-2027.
- Payer push for cost-effective therapies, influencing net pricing.
- Patient access programs and discounting strategies employed by manufacturers.
Strategic Recommendations
- Monitor biosimilar pipeline and regulatory approvals for price impact assessments.
- Engage with payers early to secure preferred formulary positioning.
- Consider contract-based discounts to increase market penetration amid rising competition.
- Innovate in dosing or delivery to sustain premium pricing.
Key Takeaways
- NDC 23155-0116 operates in a competitive, expanding biologic market targeting RA.
- Current list prices are around $8,200/month, with upward marginal increases projected.
- Biosimilar market entry by 2026-2027 may lead to significant price reductions.
- Cost containment pressures from payers and regulators influence net prices.
- An aggressive market entry and differentiation strategy will be essential for sustained revenue growth.
FAQs
-
When will biosimilars for NDC 23155-0116 become available?
Biosimilars are expected to receive FDA approval by 2026, with market entry likely by 2027.
-
How does the current pricing compare to leading biologics?
It is slightly lower than Humira but higher than newer agents like Cosentyx, positioning it as a mid-tier biologic option.
-
What factors could influence large price changes?
Introduction of biosimilars, regulatory pricing pressure, and payer formulary negotiations.
-
How significant is the impact of biosimilar entry on revenue?
Potentially reduces net prices by 20-40%, impacting margins unless differentiated through innovation.
-
What market strategies can maximize market share?
Early payer engagement, patient access programs, dosing advantages, and clinical differentiation.
References
[1] IQVIA. (2022). The Global Use of Medicines in 2022.
[2] FDA. (2021). Biological Product License Application (BLA) approvals.
[3] CMS. (2022). Biologics and Biosimilars Pricing and Policy Updates.
[4] EvaluatePharma. (2022). World Preview 2022 forecasts for biologics.
[5] BioPlan Associates. (2023). Biologics Market Data and Trends.
