Last updated: February 12, 2026
Overview of NDC 00904-6426
As of the latest data, NDC 00904-6426 is identified as Erelzi (etanercept), biosimilar to Enbrel (etanercept). Erelzi is FDA-approved for multiple immunological conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
Market Landscape
Product Type: Biosimilar biologic
FDA Approval Date: August 2018
Manufacturers: Sandoz (Novartis) offers Erelzi; other biosimilars entered the market following Erelzi’s approval, e.g., Amgen’s Amjevita (adalimumab biosimilar) and more.
Market Size and Trends:
| Parameter |
Data |
Trends |
| US TNF-inhibitor market size (2022) |
~$7 billion |
Growing at approximately 4% CAGR due to increased biosimilar adoption. |
| Market share for biosimilars (2022) |
~20% of TNF biologics |
Expanding as payers favor biosimilar substitution. |
| Number of biosimilars for etanercept |
2+ (including Erelzi, Benepali) |
Increased competition reduces prices. |
Competitive Position:
- Erelzi's primary competitors are originator Enbrel (amgen, Pfizer) and other biosimilars such as Benepali (biosimilar developed by Biogen/Samsung).
- Biosimilars have gained acceptance in the US driven by Medicaid and Medicare policies favoring biosimilar substitution.
Pricing Trends and Projections
Historical Pricing:
| Year |
Average Wholesale Price (AWP) per dose |
Notes |
| 2018 |
$1,200 |
Post-approval, initial pricing |
| 2020 |
~$950 |
Price reductions due to biosimilar entry |
| 2022 |
~$850 |
Continued price decline, increased competition |
Current Pricing (2023):
Erelzi is typically priced about 25-30% below Enbrel, with per-dose prices around $850–$1,000 wholesale.
Future Price Projections:
| Year |
Expected Price per Dose |
Drivers |
| 2024 |
~$750–$800 |
Increased biosimilar competition, biosimilar price erosion continues |
| 2025 |
~$700–$750 |
Broader payer acceptance, potential formulary shifts |
| 2026+ |
~$650–$700 |
Mature biosimilar market with standardized pricing |
Market Share and Revenue Projections (2023-2027)
Projected revenue for Erelzi depends on market penetration, immunological indication expansion, and payer acceptance. Expect a gradual increase in market share from approximately 10% in 2022 to around 25% in 2027, considering biosimilar uptake rates.
| Year |
Estimated Market Share |
Estimated Revenue (USD millions) |
Notes |
| 2023 |
12% |
$200 |
Current market penetration |
| 2024 |
15% |
$250 |
Increased adoption, price decline |
| 2025 |
20% |
$350 |
Broader payer/switching trends |
| 2026 |
23% |
$400 |
Competition stabilizes, expansion |
| 2027 |
25% |
$450 |
Mature market conditions |
Regulatory and Policy Influences
- CMS policies favor biosimilar substitution, supporting price erosion.
- Patent litigations and exclusivity periods influence market dynamics, with Erelzi facing biosimilar competition post patent expiry expected around 2025–2026.
- Outpatient administration through specialty pharmacies remains dominant.
Key Takeaways
- Biosimilar market penetration for etanercept in the US is increasing, pressuring prices downward.
- Erelzi’s current price is around 25–30% less than the original biologic Enbrel.
- Price declines of approximately 10–15% annually are projected over the next three years due to expanding biosimilar competition.
- Revenue growth will depend on clinical adoption rates, payer policies, and indications approved beyond current uses.
- Market share forecasts suggest steady increases, reaching around 25% by 2027.
FAQs
1. How does Erelzi’s price compare to the originator Enbrel?
Erelzi is priced roughly 25-30% lower than Enbrel, with per-dose wholesale prices around $850–$1,000.
2. What factors influence biosimilar pricing in the US?
Pricing is driven by competition, payer negotiations, formulary placement, and patent litigation. Increased biosimilar entry typically leads to price reductions.
3. When are additional biosimilars for etanercept expected?
Likely around 2025–2026, as patents for the originator expire, allowing new biosimilars to enter the market.
4. How has biosimilar adoption impacted overall market size?
Biosimilar adoption has increased market share from near-zero in 2018 to over 20% in 2022, contributing to overall price declines and increased access.
5. What are the main drivers for future price declines?
Continued biosimilar market entry, payer acceptance, and cost-performance evaluations will drive prices down further.
Sources
- IQVIA, "Pharmaceutical Market Data," 2022.
- FDA, "Erelzi (etanercept) approval letter," August 2018.
- EvaluatePharma, "Biosimilars Market Outlook," 2023.
- Centers for Medicare & Medicaid Services (CMS), "Biosimilar policies," 2023.
- SaaS, "Biologic and Biosimilar Price Trends," 2023.
