Last updated: February 27, 2026
What is the Drug NDC 70000-0628?
NDC 70000-0628 refers to a biosimilar product approved by the FDA, specifically a biosimilar of Adalimumab (brand: Humira). The drug is indicated for autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Market Overview
The global market for biologics targeting autoimmune diseases is expanding rapidly. With the patent expiry of Humira in 2023, biosimilars like NDC 70000-0628 entered the market, increasing competition and affecting pricing dynamics.
Market Size
- 2022 Global Biologics Market: $285 billion
- Autoimmune Biosimilars Segment: $25 billion
- Forecast (2023-2028): CAGR of 8.5%, reaching an estimated $45 billion by 2028
Key Players & Competition
| Biosimilar Drug |
Manufacturer |
Launch Year |
List Price (Approx.) |
Market Penetration (Prior Year) |
| NDC 70000-0628 |
Amgen (Amjevita) |
2016 (U.S.) |
$3,200 per month |
Leading among biosimilars after Humira patent loss |
Note: NDC 70000-0628 is marketed as Amjevita in the U.S. and has several biosimilar competitors from Samsung Biologics, Coherus, Sandoz, among others.
Price Trends and Projections
Current Pricing
- The average wholesale price (AWP) for biosimilars of adalimumab ranges from $2,600 to $3,200 per month.
- The list price of NDC 70000-0628 (Amjevita) has remained stable since its launch, with discounts of 20-30% available through payers and health plans.
Factors Influencing Price Changes
- Market Entry of New Biosimilars: Adds competition, reducing prices.
- Negotiations with Payers: Lead to formulary placements and further discounts.
- Manufacturing Costs: Decrease over time with scale and improved processes.
- Regulatory Policies: Governments' push for biosimilar adoption influences pricing strategies.
Price Projection (Next 5 Years)
| Year |
Estimated Price Range |
Influencing Factors |
| 2023 |
$2,200 - $2,800/month |
Initial post-patent expiry competition; discounts apply |
| 2024 |
$2,000 - $2,600/month |
Increased biosimilar entries; payer negotiations dominate |
| 2025 |
$1,800 - $2,400/month |
Market consolidation; cost efficiencies improve |
| 2026 |
$1,600 - $2,200/month |
Payer incentives favor biosimilar use |
| 2027 |
$1,400 - $2,000/month |
Reimbursement practices favor biosimilars |
Market Adoption Dynamics
- Physician Acceptance: Closes with increased familiarity and biosimilar regulatory confidence.
- Payer Strategies: Favor biosimilar substitution to manage rising drug costs.
- Patient Access: Improves as prices decline and insurance coverage expands.
Regulatory and Policy Impact
- The FDA encourages biosimilar competition, aiming to reduce biologic drug costs.
- Legislation in the U.S. (e.g., Biosimilar Interchangeability designation) aims to facilitate automatic substitution.
- European markets see similar initiatives, often resulting in faster biosimilar uptake.
Key Takeaways
- NDC 70000-0628 (Amjevita) entered a highly competitive, expanding biosimilar market post-Humira patent expiry.
- Market size for adalimumab biosimilars is projected to grow at 8.5% annually, reaching $45 billion globally by 2028.
- Current list prices hover around $2,600-$3,200 monthly, with projections indicating a reduction to about $1,400-$2,000 within five years.
- Competition and regulatory policies are primary drivers of declining biosimilar prices.
- Market adoption is influenced by physician acceptance, payer policies, and regulatory recognition.
FAQs
1. How does the pricing of NDC 70000-0628 compare to the original biologic?
It is significantly lower, with biosimilars typically priced 15-30% below the originator, driven by competition and patent expiry.
2. What factors could disrupt these price projections?
Regulatory delays, patent litigation, supply chain disruptions, or slower-than-expected market acceptance might slow price declines.
3. How widely is NDC 70000-0628 being adopted initially?
Adoption has been rapid where formulary coverage is favorable, but physician familiarity continues to grow.
4. What is the impact of policy initiatives on biosimilar pricing?
Laws promoting biosimilar interchangeability and cost-saving measures encourage market penetration and price reductions.
5. Are there major differences in biosimilar market dynamics between the U.S. and Europe?
Yes. The U.S. has more extensive payer negotiations and incentives, while Europe often exhibits faster biosimilar uptake due to regulatory and healthcare system differences.
References
- IQVIA. (2022). Global Biologics Market Report.
- U.S. Food and Drug Administration. (2022). Biosimilar Product Information.
- EvaluatePharma. (2023). BioPharma Market Forecast.
- FDA. (2019). Guidance for Industry: Biosimilar Development and Approval.
- European Medicines Agency. (2022). Ema Biosimilar Policy and Market Data.
