Last updated: February 22, 2026
What Is NDC 60429-0354?
NDC 60429-0354 identifies a specific pharmaceutical product. Based on current databases, it corresponds to Renflexis (infliximab-abda), a biosimilar to Johnson & Johnson’s Remicade. It is used for autoimmune diseases such as Crohn's disease, rheumatoid arthritis, and ulcerative colitis.
Market Size and Key Players
Current Market Size
The global infliximab market was valued at approximately $8.2 billion in 2022. Biosimilars like Renflexis account for roughly 12-15% of this market, with sales estimated around $1 billion.
Leading Competitors
| Product |
Manufacturer |
Approximate 2022 Sales |
Patent Status |
Patent Expiry (US) |
| Remicade (infliximab) |
Janssen (J&J) |
~$7 billion |
Expired (2018) in US |
2023 (biosimilar entry) |
| Renflexis (infliximab-abda) |
Samsung Bioepis, Merck |
Approx. $150M |
No patent, FDA approval in 2017 |
N/A |
| Inflectra (infliximab-dydd) |
Amgen/Samsung |
Approx. $120M |
No patent, FDA approval in 2016 |
N/A |
Regulatory Status
Renflexis received FDA approval in April 2017. Biosimilar market entry increased competition, reducing prices and impacting original drug sales.
Price Trends and Projections
Historical Pricing
In the U.S., the average wholesale price (AWP) for Remicade was about $1,500 per 100 mg vial in 2017. Biosimilars entered at a ~30% discount, with initial prices around $1,050 per vial.
Price Reduction Post-Biosimilar Entry
Biosimilar prices decreased by an average of 20-30% within the first year, with further reductions expected as market penetration deepens.
2023-2030 Price Projections
| Year |
Estimated Price per 100 mg vial |
Change from 2022 |
Market Penetration |
Comments |
| 2023 |
$900 |
-14% |
25% |
Entry in key markets; competitive pricing emerges. |
| 2025 |
$750 |
-17% |
45% |
Increased biosimilar adoption; price stabilization. |
| 2028 |
$600 |
-20% |
65% |
Biosimilar market dominance increases; original sales decline. |
| 2030 |
$550 |
-8% |
75% |
Market stabilizes; price plateau. |
Price reductions depend on regulatory landscape, patent litigation, insurance reimbursement policies, and provider acceptance.
Regulatory and Policy Factors Impacting Price
-
Patent Expiries: The primary patent for Remicade expired in 2018 in the U.S., facilitating biosimilar entry.
-
Interchangeability: No biosimilar has received interchangeability designation yet, limiting automatic substitution impact.
-
Pricing Policies: U.S. policies favor biosimilar competition, including potential incentives for pharmacies and providers to prefer biosimilars.
-
Reimbursement: CMS encourages biosimilar use, with reimbursement standards reducing costs for payers.
Potential for Market Growth
The infliximab biosimilar market is projected to grow annually at 8-12% over the next decade, driven by new indications, expanded insurance coverage, and increased biosimilar acceptance.
Emerging Opportunities
- New Indications: Approval for additional autoimmune diseases widens usage.
- Global Expansion: Markets like Europe and Asia show increasing biosimilar adoption, providing revenue opportunities.
- Pricing Optimization: Manufacturers focus on reducing manufacturing costs to maintain margins amid declining prices.
Summary of Price and Market Projections
- Biosimilar prices have decreased by 20-30% since initial launch.
- Prices are expected to decline further, reaching roughly $550 per 100 mg vial by 2030.
- Market penetration will continue to grow, potentially replacing a majority of original infliximab sales by mid-decade.
- Industry forecasts suggest a compound annual growth rate of 8-12% in biosimilar infliximab sales globally.
Key Takeaways
- NDC 60429-0354 (Renflexis) operates in a competitive and rapidly evolving biosimilar market.
- Price reductions will continue as biosimilar uptake expands.
- Regulatory factors, patent status, and reimbursement policies heavily influence market dynamics.
- Growth forecasts depend on approval of additional indications and international market expansion.
Frequently Asked Questions
1. How does the price of biosimilars compare to the original product?
Biosimilars typically cost 20-30% less than the reference biologic due to lower development costs and increased competition.
2. What factors influence biosimilar market penetration?
Market penetration depends on patent expiration, regulatory approval, physician and patient acceptance, reimbursement policies, and pricing strategies.
3. Are biosimilar prices expected to stabilize?
Prices are projected to stabilize around $550 per 100 mg vial by 2030, as market saturation occurs.
4. How do patent expiries affect biosimilar availability?
Patent expiry enables biosimilar manufacturers to enter the market, increasing competition and reducing prices.
5. What is the outlook for revenue from NDC 60429-0354 in the next five years?
Revenue growth will be constrained by falling prices and market share displacement from biosimilars but may offset with increased volume due to expanded indications.
References
[1] IQVIA. (2022). Global Biosimilar Market Report. IQVIA.
[2] FDA. (2023). Biosimilar Product Information. U.S. Food and Drug Administration.
[3] Evaluate Pharma. (2022). World Preview: Outlook to 2028.
[4] Centers for Medicare & Medicaid Services. (2022). Biosimilar reimbursement policies.
[5] Statista. (2023). Biologic and biosimilar market size.
