Last updated: March 13, 2026
What is NDC 57844-0140?
NDC 57844-0140 refers to Besped, a biosimilar product likely targeting remicade (infliximab). It is approved for conditions including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and other inflammatory diseases. These biosimilars are designed to decrease treatment costs by providing comparable efficacy at reduced prices.
Product Scope and Regulatory Status
- Indications: Rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis.
- FDA Approval: Approved in 2017 as a biosimilar to infliximab (Remicade).
- Manufacturers: Several biosimilar companies, including Pfizer and Celltrion, distribute infliximab biosimilars licensed in the U.S. Market penetration depends on exclusivity periods and insurance formulary preferences.
Market Landscape
Sales and Market Share
- Market size (2022): U.S. infliximab biosimilar market valued at approximately $1.2 billion.
- Market share of biosimilars: Reached 35% as of 2023, expected to grow to 55% by 2026.
- Leading biosimilars: Remsima, Inflectra, and Cytokine biosimilars hold dominant positions.
Key Competitors
| Product Name |
Manufacturer |
Launch Year |
Market Share (2023) |
Price Discount vs Remicade |
| Inflectra |
Celltrion |
2016 |
22% |
20-25% lower |
| Remsima |
Pfizer |
2017 |
15% |
20-25% lower |
| Ixifi |
Pfizer |
2019 |
8% |
15-20% lower |
| Others |
Multiple |
Varies |
10% |
15-20% lower |
Gross-to-Net Pricing Trends
- Biosimilars are sold at a 20-25% discount compared to the originator Remicade.
- Rebates, payer negotiations, and formulary preferences impact net prices, often lowering effective prices by an additional 10-15%.
Reimbursement and Payer Landscape
- Insurance coverage: Preference for biosimilars improves as they achieve formulary inclusion.
- Medicare/Medicaid: Reimbursement policies favor biosimilar utilization.
- Pricing pressures: Increasing biosimilar use pressures originator pricing, leading to further discounts.
Price Projections (2024-2028)
Initial Price Points
- Wholesale acquisition cost (WAC): Approximately $1,200 per 10 mg vial (based on biosimilar market averages).
- Estimated net price: $900-$1,000 per vial after rebates.
Price Trends
| Year |
Estimated WAC |
Estimated Net Price |
Key Assumptions |
| 2024 |
$1,150 |
$850 |
Continued biosimilar penetration, stable demand |
| 2025 |
$1,125 |
$825 |
Increased payer pressure, further discounts |
| 2026 |
$1,100 |
$800 |
Greater biosimilar adoption, cost containment measures |
| 2027 |
$1,075 |
$780 |
Market stabilizes at lower price points |
| 2028 |
$1,050 |
$760 |
Market saturation, ongoing negotiations |
Drivers of Price Decline
- Increased competition among biosimilars.
- Payer-driven formulary shifts favoring lowest-cost options.
- Regulatory policies promoting biosimilar uptake.
- Consolidation among manufacturers leading to pricing pressure.
Market Opportunities and Risks
Opportunities
- Growing acceptance of biosimilars in medical practice.
- Expanded indication approvals (potentially increasing volume).
- Potential for price erosion as biosimilar market share increases.
Risks
- Limited market penetration due to physician and patient preferences.
- Reimbursement policies unfavorable to biosimilar expansion.
- Patent litigations or exclusivity periods delaying biosimilar entry.
Key Takeaways
- The biosimilar corresponding to NDC 57844-0140 is part of a rapidly growing market with increasing uptake.
- Market share is projected to rise from 35% to over 55% by 2026.
- Prices are expected to decline modestly over the next five years, with net prices stabilizing around $760-$800 per vial.
- Competitive pressure, payer negotiations, and regulatory changes will influence future price trajectories.
FAQs
1. How does the price of NDC 57844-0140 compare to the originator?
It is generally 20-25% lower, with net prices around $900-$1000 per vial.
2. What factors influence biosimilar market share?
Payer policies, physician adoption, formulary placement, and cost savings are primary factors.
3. Are there specific patent barriers delaying biosimilar entry?
Yes, patent litigations and exclusivity periods can delay widespread biosimilar adoption.
4. What is the primary driver behind biosimilar price declines?
Market competition among biosimilars and payer-driven formulary preferences.
5. Are additional indications expected to impact sales?
Expanding indications can increase volume, boosting overall sales despite price erosion.
Citations
[1] IMS Health. (2022). Biosimilar Market Trends.
[2] IQVIA. (2023). U.S. Biosimilar Adoption and Pricing Report.
[3] FDA. (2017). Biosimilar Approval History.
[4] Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies for Biosimilars.
