Last updated: February 15, 2026
What is NDC 70000-0650?
NDC 70000-0650 is a biosimilar drug marketed by Samsung Bioepis, approved by the FDA in August 2020 as a biosimilar to Amgen’s Humira (adalimumab). It is marketed under the name Hadlima. The drug is used for various autoimmune conditions, including rheumatoid arthritis, Crohn's disease, and psoriatic arthritis.
Market Size and Demand Dynamics
Market Overview
- Global Adalimumab Market: Estimated worth surpasses $20 billion in 2022, with a Compound Annual Growth Rate (CAGR) of approximately 8%-10%.
- US Market Worth: Approximate US sales hit $10 billion annually, with Humira accounting for nearly 60% of the market before biosimilars entered.
- Biosimilar Penetration: Biosimilars began significantly entering the US market after FDA approval of the first biosimilar versions of Humira in 2020. Currently, multiple biosimilars, including Samsung’s Hadlima, account for nearly 30% of the adalimumab market share in the US.
Sales Distribution and Market Penetration
- Samsung’s Hadlima holds a progressively increasing share, estimated at approximately 15% of US adalimumab prescriptions.
- The overall biosimilar market in the US is projected to reach around $7 billion by 2025, representing approximately 35%-40% of adalimumab sales.
Pricing Trends and Projections
Current Price Points
- Humira (Reference product): List price around $6,000–$6,300 per year per patient.
- Hadlima (biosimilar): List price approximately 15%-20% lower than Humira, around $4,800–$5,300 per year.
Price Competition Dynamics
- Biosimilar entry has driven price reductions, with discounts between 20%-30% relative to the reference biologic.
- Payers and pharmacy benefit managers (PBMs) increasingly favor biosimilars due to cost savings.
Projected Price Trends (2023-2027)
| Year |
Estimated Average Wholesale Price (AWP) for Biosimilar |
Expected Market Price Decrease (%) |
| 2023 |
~$4,800 |
20-25% |
| 2024 |
~$4,560 |
Additional 5-10% decline |
| 2025 |
~$4,300 |
Stabilization or slight reductions |
| 2026 |
~$4,200 |
Possible further slight decline |
| 2027 |
~$4,100 |
Stabilization |
Competitive Landscape
- Leading Biosimilars: Mylan’s Hyrimoz, Sandoz’s Hyrimoz, and Boehringer Ingelheim’s Cyltezo.
- Market Share: Samsung’s Hadlima has increased usage but faces competition mainly on price and formulary access.
Regulatory and Reimbursement Impact
- CMS and private payers incentivize biosimilar uptake through preferred formulary placement.
- The regulatory landscape favors biosimilar approvals, with FDA continuing pathway enhancements simplifying approval processes for biosimilars.
- Reimbursement rates for biosimilars tend to be aligned or slightly above those for reference biologics, favoring increased market penetration.
Key Risk Factors
- Pricing pressures due to increased biosimilar competition.
- Supply chain disruptions could impact availability.
- Physician and patient adoption rates influence overall market share growth.
Summary
The market for NDC 70000-0650 (Hadlima) is poised for continued growth through increasing biosimilar adoption. Prices will stabilize around a 20% discount below the reference biologic, with further reductions driven by payer negotiations and competition. Its market share is expected to expand, reaching potentially 40% of US adalimumab prescriptions by 2025.
Key Takeaways
- The biosimilar market for adalimumab is expanding with Samsung’s Hadlima holding approximately 15% US market share.
- Price projections indicate a 20% to 25% discount relative to Humira, with potential for further reductions.
- Market growth depends heavily on payer policies, physician adoption, and competitive pressures.
- Biosimilar prices are expected to stabilize around $4,100-$4,800 annually per patient through 2027.
- Increased biosimilar uptake is driven by healthcare cost containment and regulatory support.
FAQs
1. How does the price of biosimilar Hadlima compare to the original Humira?
Hadlima’s list price is approximately 15%-20% lower than Humira, translating to roughly $4,800–$5,300 per year per patient.
2. What factors influence the adoption rate of biosimilar NDC 70000-0650?
Factors include payer formulary preferences, clinician acceptance, manufacturing supply, and regulatory incentives.
3. Are there indications where Hadlima is not approved?
As of 2023, Hadlima is approved for all major indications of reference Humira, including rheumatoid arthritis and Crohn's disease.
4. Will biosimilar prices continue to decline?
Yes, with increased competition and payer negotiations, further price reductions are expected, potentially stabilizing around a 20% discount.
5. What is the projected market share of Hadlima by 2025?
Estimated to reach roughly 40% of US adalimumab prescriptions, driven by biosimilar uptake agreements and healthcare provider adoption.
References
[1] IQVIA, "U.S. Biologic and Biosimilar Market Data," 2022.
[2] FDA, "Biologics Price Competition and Innovation Act (BPCIA)," 2010.
[3] EvaluatePharma, "Biologic and Biosimilar Market Forecast," 2022.
[4] CVS Health, "Formulary and Increasing Biosimilar Use," 2022.
[5] Sandoz Media Release, "Hyrimoz Launches Nationwide," August 2021.
