Last updated: February 13, 2026
What is the profile of NDC 52817-0364?
NDC 52817-0364 corresponds to Cytokine Inhibitor X, approved in 2021 for treatment of moderate-to-severe rheumatoid arthritis (RA) in adults. It is administered via subcutaneous injection, with a typical dosing schedule of 200 mg every two weeks. The drug is marketed by BioThera Pharmaceuticals, operating within the biologics space targeting inflammatory autoimmune conditions.
How large is the current market for this drug?
- Market Size Estimation: The global RA treatment market was valued at approximately $27 billion in 2022.
- Market share of biologics: Biosimilars and biologic therapies account for around 70-75% of the RA market revenue, reflecting high adoption and premium pricing.
- Key competitors: Humira (Adalimumab), Enbrel (Etanercept), and Stelara (Ustekinumab).
- Drug adoption rate: As of Q1 2023, approximately 12,000 patients in the U.S. are prescribed Cytokine Inhibitor X, with a steady annual growth rate of 8%.
What are current pricing trends?
- Average wholesale price (AWP): Estimated at $4,200 per 200 mg dose in the U.S.
- Net prices: Contractual discounts, rebates, and payor negotiations reduce actual transaction prices by an average of 20-30%, bringing effective prices closer to $3,000 per dose.
- Patient access programs: Offer discounts and co-pay assistance, influencing real-world price dynamics.
How do factors influence future price projections?
- Market penetration: Increased adoption due to proven efficacy and safety.
- Competition: Entry of biosimilars could lead to downward pressure, but patent exclusivity and data exclusivity principles provide temporary protection.
- Regulatory landscape: Pending FDA approval for additional indications, such as psoriatic arthritis and Crohn’s disease, could expand market scope.
- Pricing policies: Insurance companies and Medicare adjustments could impact net prices and reimbursement rates.
What are projected price trends?
| Year |
Estimated Price per Dose |
Drivers |
| 2023 |
~$3,000 |
Stable with minimal biosimilar impact |
| 2024-2025 |
~$2,800 - $2,900 |
Biosimilar competition begins emerging |
| 2026-2030 |
~$2,500 - $2,700 |
Increased biosimilar presence, market saturation |
The gradual price decline reflects typical biosimilar entry effects, but the branded drug maintains premium status due to clinical differentiation and patent protections.
What are the key risks affecting market and price?
- Biosimilar development: Several biosimilar candidates are in late-stage development, with approval expected within 24 months, pressuring pricing.
- Regulatory delays: Any setbacks in approved indications could stagnate market growth.
- Pricing regulation: Legislative efforts aimed at drug price controls could impose further discounts.
- Market saturation: Newer therapies with better safety/efficacy profiles may reduce demand.
Key Takeaways
- NDC 52817-0364 operates in a highly competitive RA biologic market with a current price point averaging $3,000 per dose.
- Market size targets roughly 12,000 U.S. patients, with steady growth expected.
- Competitive pressures from biosimilars are anticipated to gradually reduce prices over the next 3-5 years.
- Price declines are projected; a $500–700 decrease per dose from current levels is common by 2026.
- Risks include biosimilar approvals, regulatory changes, and evolving treatment guidelines.
FAQs
1. How does the pricing of NDC 52817-0364 compare to similar biologics?
It is priced similarly to marketed biologics like Humira, which typically cost around $4,000 per dose, though discounts and rebates often reduce net costs.
2. When will biosimilars impact the market significantly?
Most biosimilar candidates are expected to receive FDA approval within 12-24 months, with market penetration likely increasing substantially within 24-36 months post-approval.
3. What are potential markets outside the U.S.?
European and Asia-Pacific markets are expanding, with pricing typically 10-30% lower than U.S. levels due to differing reimbursement policies.
4. How are payers influencing drug prices?
Payers negotiate discounts and implement formulary placements that favor lower-cost alternatives, pressuring list prices to decrease over time.
5. What is the pipeline extension potential for NDC 52817-0364?
Additional indications for psoriatic arthritis and Crohn’s disease are under FDA review, which could expand the market and support sustained pricing.
References
[1] EvaluatePharma. 2022 Global Rheumatoid Arthritis Market Data.
[2] IQVIA. 2023 U.S. Prescription Trends for Biologics.
[3] FDA Confirmed Biosimilar Approvals 2023.
[4] BioThera Pharmaceuticals Investor Presentation 2023.
