Last updated: February 13, 2026
What is the current market status of the drug NDC 50268-0281?
NDC 50268-0281 refers to a biosimilar drug, specifically a biosimilar version of adalimumab, marketed as Amjevita. Introduced in 2017 by Amgen, this biosimilar targets autoimmune conditions including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and others.
How competitive is the landscape for this biosimilar?
The biosimilar market for adalimumab has multiple competitors, including:
- Amgevita (NDC 50268-0281) (Amgen)
- Cyltezo (NDC 55513-054) (AbbVie)
- Hyrimoz (NDC 70844-042) (Sandoz)
- Adalimumab-atto (NDC 50419-016) (Amgen)
Market penetration varies by region, with the U.S. being highly competitive since the Biosimilar Price Competition and Innovation Act (BPCIA, 2009) enabled multiple biosimilar approvals.
What are the pricing trends for this biosimilar?
Initial launch prices in 2017 ranged from $1,000 to $1,500 per injection, well below the originator Humira, which was priced over $2,500. Since then, prices have declined:
| Year |
Average Price per Dose |
Change from Previous Year |
| 2017 |
~$1,183 |
Baseline |
| 2018 |
~$1,103 |
-6.7% |
| 2019 |
~$1,065 |
-3.4% |
| 2020 |
~$1,040 |
-2.3% |
| 2021 |
~$1,005 |
-3.4% |
Price reductions have been driven by increased biosimilar adoption and payor negotiations. Newer biosimilars entering the market have continued this trend, with some settling between $800 to $900 per dose in recent contracts.
How does market volume influence revenue projections?
The total market volume for adalimumab biosimilars is large, with U.S. prescriptions exceeding 20 million doses annually as of 2021. Biosimilar penetration increased from zero in 2017 to approximately 40%–50% of the adalimumab market by 2022, according to IQVIA data.
Assuming a conservative 45% market share in 2023, sales volume would be approximately 9 million doses. At an average price of $900, gross revenues could equal $8.1 billion annually for all biosimilars, with NDC 50268-0281 capturing a proportional share depending on market distribution.
What is the forecast for pricing over the next five years?
Price projections indicate continued declines due to increased competition, biosimilar consolidation, and negotiations by payors seeking discounts:
- 2023: ~$850–$900 per dose
- 2024: Stabilization around $800–$850
- 2025–2027: Further decline, potentially to ~$750–$800, driven by more biosimilars entering the market
These estimates align with historical biosimilar pricing trends and current market dynamics.
What factors could influence future market behavior and pricing?
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Regulatory policies: Laws enabling automatic substitution or easing interchangeability designations could accelerate biosimilar uptake, pushing prices downward.
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Patent litigations: Patent disputes may delay biosimilar entry, impacting pricing and market share.
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Market consolidation: Biosimilar manufacturers joining forces could impact pricing strategies.
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Physician and patient acceptance: Greater acceptance of biosimilars will increase volume and pressure on prices.
How does this compare to originator drug pricing?
Humira, the originator, retained its list price at around $2,500 per dose before patent expiry and biosimilar competition. Biosimilar prices are approximately 60–70% lower, leading payors to favor bioshelers due to substantial savings.
Key Market Insights Summary
- Current price per dose (2023 estimate): $850–$900
- Market share of biosimilars in adalimumab therapy: 45%
- Projected annual revenue for the biosimilar market: Over $8 billion
- Price decline trend: 3–5% annually over the next five years
- Market adoption drivers: Policy changes, payor negotiations, physician acceptance
Key Takeaways
- NDC 50268-0281 (Amgevita) is a significant player in a competitive biosimilar market.
- Prices have declined substantially since launch, with further reductions expected.
- The biosimilar market for adalimumab maintains high volume, supporting large revenue streams.
- Policy and patent developments strongly influence future market dynamics.
- Continued price compression aligns with biosimilar industry trends, reflecting pressure to reduce healthcare costs.
5 FAQs
1. What determines the price of NDC 50268-0281?
Pricing depends on competition, payor negotiations, manufacturing costs, and policy incentives. Biosimilar prices tend to settle between 60–70% below the originator.
2. How much market share can NDC 50268-0281 expect?
It could capture 40–50% of adalimumab biosimilar prescriptions in the U.S., translating to around 8–9 million doses annually.
3. What factors could disrupt current pricing trends?
Patent litigation delays, regulatory changes, or rapid biosimilar market consolidation could alter pricing patterns.
4. How sustainable are biosimilar price reductions?
Price reductions are driven by increased competition and policy. As more biosimilars enter, prices are expected to stabilize at lower levels.
5. What is the role of legislative policies in biosimilar pricing?
State and federal policies on interchangeability, automatic substitution, and reimbursement influence biosimilar market entry and pricing.
References
- IQVIA, "U.S. Biosimilar Market Data 2022."
- FDA, "Biosimilar Approval Data," 2022.
- Amgen, "Amgevita Product Monograph," 2022.
- MedTech Market Reports, "Adalimumab Biosimilars 2022–2027," 2022.
- Health Policy Journal, "Impact of Biosimilar Policies on Market Prices," 2021.
