Last updated: March 11, 2026
What Is NDC 69238-1729?
NDC 69238-1729 is a biosimilar drug marketed as a lower-cost alternative to a reference biologic medication. Specifically, it is a biosimilar version of infliximab, used primarily to treat autoimmune disorders such as rheumatoid arthritis, Crohn’s disease, and psoriasis. It received FDA approval in 2021.
Market Overview
Product Description
- Generic Name: Infliximab biosimilar
- Brand: Prescribed under various brand or generic labels (depending on manufacturer)
- Therapeutic Area: Autoimmune diseases
- Approval Year: 2021
Key Competitors
| Product Name |
Manufacturer |
Approval Year |
Price Range (per vial) |
Market Share (2022) |
| Remicade (reference biologic) |
Janssen |
1998 |
$1,200 - $2,000 |
75% |
| Inflectra |
Cellset (Pfizer) |
2016 |
$700 - $1,200 |
15% |
| Renflexis |
Samsung Bioepis |
2017 |
$700 - $1,100 |
5% |
| Nucala (non-biosimilar) |
GlaxoSmithKline |
N/A |
N/A |
N/A |
| NDC 69238-1729 (biosimilar) |
Various manufacturers |
2021 |
$600 - $1,000 |
Emerging |
Market Size and Growth Trends
The infliximab biosimilar market has expanded significantly in the last five years, driven by high drug prices and formulary preferences. Total U.S. biosimilar infliximab sales surpassed $2 billion in 2022, representing over 10% growth from 2021.
Regulatory and Reimbursement Landscape
- Manufacturers face reimbursement hurdles due to longstanding payer contracts with originators.
- CMS expanded biosimilar coverage in multiple pathways.
- State legislation encourages biosimilar substitution, although substitution laws vary by state.
Price Projections
Historical Pricing Trends
| Year |
Average Price per Vial |
Market Share of Biosimilars |
Key Influencers |
| 2020 |
$1,200 - $1,500 |
10% |
Patent expirations, biosimilar approvals |
| 2021 |
$900 - $1,200 |
15% |
Market entry of biosimilars, payer formulary changes |
| 2022 |
$700 - $1,000 |
25% |
Increased biosimilar utilization, discounting strategies |
Projected Price Trajectory (2023-2027)
| Year |
Estimated Price Range per Vial |
Price Drivers |
| 2023 |
$600 - $900 |
Increased biosimilar adoption |
| 2024 |
$550 - $850 |
Market saturation, price competition |
| 2025 |
$500 - $800 |
Streamlined manufacturing, competitive pricing |
| 2026 |
$450 - $750 |
Payer negotiations, patent challenges |
| 2027 |
$400 - $700 |
Elevated biosimilar market share |
Key Factors Influencing Price Decline
- Entry of additional biosimilar competitors.
- Payer pressure to substitute originators with biosimilars.
- Manufacturing efficiencies reducing production costs.
- Increased market volume leading to economies of scale.
Market Opportunities and Risks
Opportunities
- Growing acceptance of biosimilars in clinical practice.
- Expiring patents of reference biologics.
- Favorable pricing trends post-patent expiration.
Risks
- Patent litigation delays for new biosimilars.
- Resistance from providers accustomed to originator biologics.
- Variability in reimbursement policies across jurisdictions.
Key Takeaways
- NDC 69238-1729 entered a rapidly growing biosimilar market for infliximab in 2021.
- Average prices have declined approximately 50% since 2020 and are projected to decrease further over the next five years.
- Market share expansion hinges on biosimilar manufacturers' ability to negotiate payers and demonstrate value.
- Price competition will intensify as manufacturers introduce additional biosimilars and manufacturing costs decrease.
FAQs
Q1: Will the price of NDC 69238-1729 fall below $400 by 2027?
A1: Possible if market penetration continues and manufacturing efficiencies improve, but regulatory and reimbursement factors may influence the lower bounds.
Q2: How does the biosimilar pricing compare to the original biologic?
A2: Biosimilar prices typically range from 30% to 50% below the reference biologic, with some achieving reductions of up to 60%.
Q3: What factors could slow down price reductions?
A3: Patent disputes, supply chain constraints, or slower-than-expected adoption by clinicians could impede price declines.
Q4: Are there differences in pricing across markets?
A4: Yes. The U.S. market tends to have higher prices than Europe and other regions due to different reimbursement systems.
Q5: How might biosimilar market share impact overall prices?
A5: Increasing biosimilar market share tends to lower overall prices due to increased competition and negotiated discounts.
References
[1] IQVIA. (2023). Biosimilar Market Data.
[2] FDA. (2021). Approval of infliximab biosimilar.
[3] Centers for Medicare & Medicaid Services. (2022). Biosimilar Coverage Policy.
[4] EvaluatePharma. (2022). Oncology Biosimilars Market Analysis.
[5] Sagonowsky, E. (2022). Biosimilar pricing trends. FiercePharma.
