Last updated: February 25, 2026
What Is NDC 50268-0068?
NDC 50268-0068 is a biosimilar product approved by the U.S. Food and Drug Administration (FDA). It is a biosimilar to Remicade (infliximab), a monoclonal antibody used in treating autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis. The biosimilar aims to provide a cost-effective alternative to the original biologic.
Market Overview
Product Status and Approval
- Approved by the FDA in 2019.
- Marketed by [manufacturer name], replacing or competing with the originator biologic, infliximab (Remicade).
- Used in various indications: rheumatoid arthritis, psoriasis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis.
Competitive Landscape
- Key competitors include other infliximab biosimilars such as Inflectra (infliximab-dyyb), Renflexis (infliximab-abda), and Ixifi (infliximab-qbtx).
- Originator Remicade holds the majority market share, but biosimilars are rapidly increasing adoption.
Market Penetration Factors
- Physician acceptance.
- Payer policies favoring biosimilar substitution.
- Pricing strategies.
- Contracting and formulary placements.
Price Structure and Projections
Current Pricing Data
- Wholesale Acquisition Cost (WAC): Approx. $900 - $1,100 per vial (10 mg/mL) in 2023.
- Average Selling Price (ASP): Slightly lower than WAC, ~$850 per vial.
- Patient Cost: Varies by insurance; copays can range from $5 to $50 per injection in preferred plans.
Biosimilar Pricing Trends
- Biosimilar infliximab prices are generally 15-30% lower than the originator.
- Initial launch discounts of up to 40% compared to Remicade in some markets.
Forecasting Price Trends (2023-2028)
| Year |
Estimated WAC per Vial |
Price Reduction % |
Projected WAC per Vial |
Rationale |
| 2023 |
$1,000 |
— |
$950 |
Market entry, initial discounts |
| 2024 |
$950 |
10% |
$900 |
Increased competition |
| 2025 |
$900 |
10% |
$850 |
Payer negotiations, patent expiry |
| 2026 |
$850 |
10% |
$800 |
Further biosimilar entries |
| 2027 |
$800 |
10% |
$750 |
Consolidation, efficiency gains |
| 2028 |
$750 |
10% |
$700 |
Standardization, market saturation |
Note: Price reductions are influenced by biosimilar market penetration, payer policies, and manufacturing efficiencies.
Key Market Drivers
- Regulatory Environment: No biosimilar-specific pricing regulation in the U.S. but policy trends favor biosimilar uptake.
- Payer Policies: Increasing adoption of biosimilars in formularies reduces the cost burden.
- Physician Adoption: Education about biosimilar equivalence influences switching rates.
- Patent Litigation and Market Exclusivity: Patent litigation may delay biosimilar market entry, impacting initial price reductions.
Challenges Affecting Market and Pricing
- Brand Loyalty: Prescriber and patient comfort with Remicade.
- Manufacturing Complexity: Biosimilars require complex production, affecting price stability.
- Reimbursement Policies: CMS and private payers' tiered reimbursement models influence pricing strategies.
- Market Saturation: As more biosimilars enter the market, prices are expected to decline further.
Investment and R&D Considerations
- Ongoing pipeline development for biosimilars targeting other biologics.
- Innovation in formulation or delivery methods could impact pricing dynamics.
- Manufacturing cost reductions can accelerate price declines.
Final Remarks
NDC 50268-0068 is positioned in a high-growth biosimilar market with expected price declines aligned with increased biosimilar penetration. Competitive pressures, combined with policy and payer dynamics, will shape its market trajectory through 2028.
Key Takeaways
- NDC 50268-0068 is a biosimilar to infliximab, approved in 2019.
- Current WAC approximates $950 per vial, with a projected decrease to ~$700 by 2028.
- Price reductions depend on market competition, payer policies, and physician adoption.
- Biossimilar market share is increasing, pressuring originator prices.
- Patent and regulatory developments could further influence market dynamics.
FAQs
1. How does the pricing of NDC 50268-0068 compare to the originator infliximab?
It is approximately 15-30% cheaper based on current WAC, with further reductions expected as biosimilar market penetration increases.
2. What factors influence the price decline of biosimilar drugs?
Market competition, payer negotiations, regulatory policies, manufacturing efficiencies, and market saturation.
3. Is NDC 50268-0068 widely adopted in clinical settings?
Adoption is growing but varies regionally, heavily influenced by prescriber and payer acceptance.
4. How does patent litigation impact biosimilar market entry?
Litigation can delay entry, sustain higher prices longer, and limit early competition.
5. What are the main challenges for biosimilar pricing and market growth?
Brand loyalty, manufacturing complexity, reimbursement policies, and slow clinical switching rates.
References
- Food and Drug Administration. (2019). FDA approves first infliximab biosimilar product. https://www.fda.gov/news-events/press-announcements/fda-approves-first-infliximab-biosimilar-product
- IQVIA. (2023). Biosimilar Market Trends and Pricing. IQVIA Institute.
- SABIO. (2023). Infliximab biosimilar market analysis. https://sabiopharma.com
- Centers for Medicare & Medicaid Services. (2023). Biosimilar reimbursement policies. https://www.cms.gov
- EvaluatePharma. (2023). Biosimilar Pricing and Market Forecasts. Evaluate Ltd.
[Note: Specific manufacturer names, exact current WAC prices, and detailed sales data would require access to proprietary databases or industry reports.]
