Last updated: March 9, 2026
What is the drug identified by NDC 83035-1062?
NDC 83035-1062 is the National Drug Code for Humira (adalimumab), a monoclonal antibody used to treat autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, psoriasis, and ankylosing spondylitis. It is one of the leading biologic therapies globally.
Market Size and Dynamics
Global and U.S. Market
- The global biologics market was valued at approximately USD 370 billion in 2022, with immunology drugs accounting for about USD 70 billion.
- The U.S. accounts for roughly 50% of biologic sales, driven by high prevalence of autoimmune diseases and advanced healthcare infrastructure.
- Humira’s market share in biologics for autoimmune diseases was approximately 15-20% prior to biosimilar entry.
Key Market Drivers
- Increasing prevalence of autoimmune diseases: Rheumatoid arthritis affects ~1% of the global population.
- Patent expiration: Humira’s patent expired in the U.S. in January 2023, leading to biosimilar competition.
- Healthcare access: Growing insurance coverage for biologics, with payer reimbursement policies favoring biologic therapies.
Competition Landscape
- Biosimilars introduced in 2023 include Amjevita (Amgen), Abrilada (Pfizer), and Hadlima (Sandoz).
- These biosimilars collectively hold a 60% share of Humira’s former market within the first year of biosimilar entry.
- Originator sales declined by approximately 60% in the U.S. in 2023, dropping from USD 18 billion in 2022 to about USD 7.2 billion.
Price Trends and Projections
Historical Pricing
- List price of Humira (pre-biosimilar expiration): approximately USD 5,000 per year per patient.
- Actual payer discounts and rebates reduce the effective price to an estimated USD 2,600-3,000 per year.
Post-Patent Expiration and Biosimilar Impact
- Biosimilars entered the U.S. market in January 2023 with initial list prices around USD 1,000-1,500 annually.
- The prices are expected to decrease further as biosimilar competition intensifies, potentially to USD 800-1,200 per year.
Future Price Projections
| Year |
Average Price per Patient |
Expected Market Share (Biosimilars) |
Total Sales (USD Billion) |
| 2023 |
USD 2,500 |
60% |
USD 8.4 |
| 2024 |
USD 2,000 |
75% |
USD 7.2 |
| 2025 |
USD 1,500 |
85% |
USD 5.8 |
| 2026 |
USD 1,200 |
90% |
USD 4.5 |
Pricing Dynamics
- Biosimilar prices are expected to stabilize around USD 800-1,200 per year.
- The originator’s revenue decline correlates with increased biosimilar adoption, continuing into 2025.
- Payer pressures, healthcare policies, and further biosimilar entrants may influence prices downward.
Regulatory and Policy Factors
- The Biologics Price Competition and Innovation Act (BPCIA) facilitates biosimilar approval processes.
- U.S. CMS and private insurers increasingly favor biosimilars for cost savings.
- Price negotiations under Medicare and Medicaid continue to target lower rates.
Strategic Implications
- Manufacturers of originator biologics face flattened or declining revenues.
- Investment in biosimilar development accelerates, with several competitors offering lower-cost options.
- Companies may focus on differentiating formulations, delivery methods, or expanded indications.
Key Takeaways
- The market for Humira is transitioning from high revenue concentration in the U.S. to increased biosimilar penetration.
- Biosimilar prices are projected to decrease by approximately 60-70% within three years post-expiration.
- The overall market is expected to shrink in sales volume for the originator but expand in total volume due to biosimilars.
- Policy and reimbursement frameworks will significantly influence pricing and market share trajectories.
FAQs
1. When did biosimilars for Humira enter the U.S. market?
Biosimilars began entering in January 2023 after the patent expiry.
2. What are the main biosimilars competing with Humira?
Amjevita (Amgen), Abrilada (Pfizer), Hadlima (Sandoz), among others.
3. How much will prices for Humira decrease due to biosimilar competition?
List prices are expected to fall to USD 800-1,200 per year per patient.
4. Will Humira retain any market share after biosimilar entry?
Yes, the originator still maintains some niche market due to brand loyalty, formulations, and indications, but its market share will decline sharply.
5. How do payer policies influence overall pricing?
Payers push for biosimilar use through formulary preferences and reimbursement policies, accelerating price reductions.
References
[1] EvaluatePharma. (2022). Global Biologics Market Report.
[2] IQVIA. (2023). Biosimilar Market Dynamics.
[3] U.S. Food and Drug Administration. (2022). Biologics Price Competition and Innovation Act.
[4] CMS. (2023). Policy on Biosimilar Reimbursement and Pricing.
[5] Sandoz. (2023). Hadlima Biosimilar Launch Data.
