Last updated: February 14, 2026
What Is NDC 00904-6583?
NDC 00904-6583 refers to Avelumab (800 mg), marketed under the brand name Bavencio. It is a programmed death-ligand 1 (PD-L1) inhibitor approved for several oncology indications, notably metastatic Merkel cell carcinoma and urothelial carcinoma. Developed by Pfizer, it received FDA approval in 2017.
Market Landscape Overview
Approved Indications:
- Merkel cell carcinoma (metastatic/unresectable)
- Urothelial carcinoma (including treatment-naïve and previously treated)
Market Size & Growth Drivers:
- The global oncology immunotherapy market was valued at $51.4 billion in 2022.
- Expected to grow at a CAGR of around 10% (2023-2030), driven by expanding indications and increasing cancer incidence.
- Merkel cell carcinoma incidence in the U.S.: approximately 1,000 cases annually, but market potential is limited; urothelial carcinoma has higher incidence, with over 81,000 new cases in the U.S. annually [1].
Key Competitors:
- Atezolizumab (Tecentriq)
- Durvalumab (Imfinzi)
- Pembrolizumab (Keytruda)
- Nivolumab (Opdivo)
Market Dynamics:
- Avelumab’s unique positioning in Merkel cell carcinoma provides limited but potent niche market share.
- In urothelial carcinoma, it faces competition from pembrolizumab and atezolizumab, which have broader indications and higher market penetration.
- Pricing significantly influences market share, with immunotherapies typically priced between $10,000 and $15,000 per infusion in the U.S.
Pricing Analysis
Current U.S. Market Price:
- The wholesale acquisition cost (WAC) for Bavencio (800 mg dose) approximates $7,000 to $8,000 per dose.
- Treatment regimens often involve multiple doses: typically every 2 or 4 weeks, totaling $28,000 to $112,000 per patient annually depending on the indication and treatment duration.
Pricing benchmarks compare:
| Drug |
Price per Dose |
Doses per Treatment Cycle |
Approximate Annual Cost |
| Bavencio (Avelumab) |
$7,500 |
8 |
$60,000 |
| Keytruda (Pembrolizumab) |
$7,500 |
8 |
$60,000 |
| Tecentriq (Atezolizumab) |
$7,000 |
8 |
$56,000 |
Note: Manufacturer discounts, payer negotiations, and patient assistance programs typically reduce net prices.
Price Trends and Projections
Factors Influencing Future Pricing:
- Entry of biosimilars, though limited for PD-L1 inhibitors due to patent protections.
- Competitive pressure from expanding indications and combination therapies.
- Price regulation policies, particularly in Europe and other markets.
Market Entry of Biosimilars:
- As of 2023, biosimilar PD-L1 inhibitors are in early development stages, with limited approval in select markets.
- Patent expiry for Bavencio's base formulation expected post-2025, possibly opening pathways for biosimilar competition.
Projected Price Trajectory (Next 5 Years):
| Year |
Estimated Price Range (U.S.) |
Notes |
| 2023 |
$7,000 – $8,000 |
Current prices remain stable amid limited competition. |
| 2025 |
$6,500 – $7,500 |
Potential slight decline due to market maturation and biosimilar approvals. |
| 2030 |
$6,000 – $7,000 |
Possible further reductions, especially if biosimilars gain market share or reimbursement policies tighten. |
Implications for Companies & Investors
- The high cost of avelumab limits expansion in lower-income markets, but the rising adoption in the U.S. and European markets maintains a profitable niche.
- Patent expiration and biosimilar development remain critical to long-term price erosion.
- The clinical development pipeline for combination therapies and new indications could influence future pricing dynamics.
Summary of Critical Data
- Avelumab is priced at approximately $7,500 per 800 mg dose.
- Annual treatment costs are approximately $60,000, though variations exist.
- Market is highly competitive with key alternatives, with modest niche opportunities in Merkel cell carcinoma.
- Prices projected to decline slightly over the next 5 years due to biosimilar pressures and market saturation.
Key Takeaways
- NDC 00904-6583 (Avelumab) holds a niche but important share in oncology immunotherapy.
- Current U.S. pricing approximates $7,500 per dose, with annual costs around $60,000.
- Market growth driven by expanding indications and combination therapies; competition affects pricing.
- Price trajectory suggests slight declines by 2030, contingent on biosimilar development and market penetration.
- Investors should monitor patent timelines, biosimilar developments, and regulatory policies influencing future pricing.
FAQs
1. How does Bavencio's pricing compare to other PD-L1 inhibitors?
The price per dose is similar among PD-L1 inhibitors like Tecentriq, Imfinzi, and Keytruda, with standalone costs around $7,000 to $7,500. Differences typically arise from dosing schedules and negotiated discounts.
2. What factors could accelerate a price decline for avelumab?
Patent expiry, biosimilar approvals, increased competition, and regulatory pressure could lower prices.
3. Are biosimilars for avelumab approved globally?
As of 2023, biosimilars are in development, with limited approvals mainly outside the U.S. and Europe.
4. What is the primary driver of avelumab's revenue?
The urothelial carcinoma indication accounts for most revenue due to higher incidence rates. Merkel cell carcinoma's niche status provides limited contribution.
5. How might new indications impact pricing?
Additional approved uses, especially in earlier-line settings, could sustain or increase prices due to expanded market share.
References
- American Cancer Society. Cancer Facts & Figures 2022.
- EvaluatePharma. Oncology Market Report 2022.
- FDA. Bavencio (Avelumab) Approval Announcements.
- GoodRx. Average U.S. drug prices 2023.
