Last updated: February 16, 2026
Overview of NDC 60505-4772
NDC 60505-4772 refers to a specific pharmaceutical product registered with the FDA, generally identified as Erelzi (etanercept-szzs). Erelzi is a biosimilar to Enbrel (etanercept) used for autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and Plaque Psoriasis.
Market Landscape
Product Classification:
Erelzi is a biosimilar biologic, approved by the FDA in August 2017. It entered the biologic marketplace competing directly with the original biologic Enbrel, which held dominant market share since 1998.
Market Size and Growth Drivers:
- The global biologics market was valued at approximately USD 300 billion in 2022.
- The biosimilar segment constitutes roughly 25% of the biologic market, expected to grow at compounded annual growth rate (CAGR) of about 27% through 2028 [1].
- The U.S. biosimilar market is projected to reach USD 25 billion by 2028, driven by policy changes and patent expirations.
Key Competitors in the Market:
| Product |
Manufacturer |
Approval Year |
Market Share (US, 2022) |
Indication Diescribed |
| Enbrel (etanercept) |
Amgen/Biogen |
1998 |
100% (original biologic) |
Rheumatoid arthritis |
| Erelzi |
Sandoz (Novartis) |
2017 |
Estimated 15-20% of biosimilar share |
Same indications |
| Other Biosimilars |
Multiple |
2018-2022 |
Increasing, total biosimilar share |
Rheumatoid, psoriatic conditions |
Market Entry Challenges:
- Patent litigations and exclusivity periods delayed biosimilar proliferation.
- Switch rates from the innovator biologic to biosimilars are still developing, impacting uptake.
Pricing Trends
Historical Pricing:
- When launched, Erelzi was priced approximately 15–20% lower than Enbrel's average wholesale price (AWP).
- Current average wholesale price (AWP): USD 2,500–USD 3,000 per month per patient, depending on dosing and region [2].
Market Discounts and Reimbursement:
- Insurers increasingly favor biosimilars; rebates and discounts for biosimilars can range from 20% to 40% off list prices.
- Medicaid and Medicare policies promote biosimilar utilization, further constraining prices.
Price Projections (Next 3-5 Years):
| Year |
Projected ASP (Average Selling Price) per month |
Notes |
| 2023 |
USD 2,300–USD 2,700 |
Slight decrease due to increased biosimilar entries |
| 2024 |
USD 2,100–USD 2,500 |
Competitive pressures intensify |
| 2025 |
USD 2,000–USD 2,400 |
Reimbursement policies favor biosimilars |
| 2026 |
USD 1,900–USD 2,300 |
Market stabilizes with multiple biosimilars |
| 2027 |
USD 1,800–USD 2,200 |
Further price reductions |
Note: Actual prices vary by payer, region, and negotiated rebates. The trend indicates prices will continue to decline through increased biosimilar competition and policy measures.
Regulatory and Policy Factors Impacting Prices
- FDA Biosimilar Pathway: Facilitates market entry but delays persist due to patent litigation.
- Interchangeability Designations: Not yet widespread, but could influence pricing if more biosimilars are deemed interchangeable with Enbrel.
- Reimbursement Trends: CMS (Centers for Medicare & Medicaid Services) policies increasingly promote biosimilar adoption, pressuring prices downward.
Investment and Commercialization Outlook
- Manufacturers expanding biosimilar portfolios are expected to introduce new competitors, intensifying price competition.
- Innovation in biosimilar manufacturing, such as production cost efficiencies, will influence pricing strategies.
Key Takeaways
- The drug identified by NDC 60505-4772 is a biosimilar to Enbrel, with growing market share since its 2017 approval.
- The U.S. biosimilar market is expanding rapidly, with prices gradually declining as competition increases.
- Current average prices range from USD 2,300 to USD 3,000 per month; projections suggest continued declines toward USD 1,800–USD 2,200 by 2027.
- Policy developments and patent litigations remain key hurdles and influencers for pricing.
- Manufacturers focusing on cost efficiencies could further accelerate price reductions, affecting profitability.
FAQs
1. How does the current market share of Erelzi compare to the original biologic Enbrel?
Erelzi holds approximately 15-20% of biosimilar market share since 2017, but Enbrel continues dominant in overall biologic usage.
2. What factors are driving the decline in biosimilar prices?
Increased competition, rebates, reimbursement policies favoring biosimilars, and manufacturing efficiencies push prices downward.
3. Are there regulatory hurdles impacting Erelzi’s market share growth?
Yes. Patent litigations and delays in designation as an interchangeable biosimilar impact market penetration.
4. How do biosimilar pricing trends differ globally?
Pricing reductions are more aggressive in regions with government price controls, such as Europe and parts of Asia. The U.S. trend is gradual due to market, regulatory, and payer dynamics.
5. What is the likelihood of additional biosimilar entrants into the Erelzi market?
High, as multiple manufacturers develop biosimilars for etanercept; approval and market entry could further compress prices starting from 2024 onward.
References
[1] Grand View Research, "Biosimilars Market Size & Trends," 2022.
[2] GoodRx, "Erelzi Price and discounts," 2023.
