Last updated: February 27, 2026
What is NDC 13668-0189?
NDC 13668-0189 corresponds to a biosimilar product of the reference biologic drug Remicade (infliximab). Biosimilars are characterized by high similarity with no clinically meaningful differences in safety or efficacy from the reference product.
This product entered the market following FDA approval, which occurred in 2019. Its primary indications include rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, and psoriatic arthritis.
Market Landscape
Key Competitors
- Remicade (original biologic): Market dominance prior to biosimilar entry
- Inflectra (Infliximab-Dyyb): Approved in 2016, first biosimilar of infliximab in the U.S.
- Avsola (Infliximab-axxq): Approved in 2019
- Cyltezo (Infliximab-aaf): Approved in 2017
- Other biosimilars: Developed globally, with varying approval dates
Market Size
- In 2022, U.S. infliximab prescription sales hit approximately $4.6 billion.
- Biosimilar penetration reached roughly 35% of infliximab prescriptions.
- Estimated biosimilar sales in 2023 are projected to surpass $1.6 billion.
Adoption Factors
- Payer acceptance and formulary preferences favor biosimilars to reduce costs.
- Institutional contracts and tender programs influence uptake.
- Physician familiarity and confidence affect prescribing behavior.
Regulatory and Policy Trends
- The U.S. Biosimilar Rule: Facilitates quicker approvals, lowers barriers.
- State laws: Encourage or mandate substitution, impacting market share.
- Price transparency and exclusivity periods influence biosimilar entry.
Price Trends and Projections
Current Pricing
- Brand (Remicade): Average wholesale price (AWP) approximately $5,000 per 100 mg vial.
- Biosimilar (NDC 13668-0189): Market prices vary, generally ranging from $1,200 to $2,300 per 100 mg vial.
Price Discounting Patterns
- Biosimilars typically launch at a 15-30% discount compared to the reference.
- Over time, discounts can increase to 40-60% as more biosimilars enter the market.
Short-term Price Outlook (2023-2025)
- Continued price reductions expected as generic biosimilar competition intensifies.
- Initial discounts of 20-30% are typical; discounts could reach 50% by 2025 if multiple biosimilars gain market share.
- Payer negotiations and rebate strategies significantly influence net prices.
Long-term Projections (2026-2030)
- Biosimilar prices are projected to stabilize at 40-60% below the reference biologic.
- Price declines will depend on market saturation, healthcare policies, and manufacturing costs.
- No major innovations expected to alter biosimilar pricing significantly during this period.
Market Entry and Pricing Strategy Considerations
- Early Entry: Allows capture of significant market share at higher prices.
- Volume Strategies: Aggressive discounts to gain formulary placement.
- Partnerships: Collaborations with payers enhance access and adoption rates.
Summary of Market Dynamics
| Aspect |
Details |
Implication |
| Market size |
$4.6 billion in 2022 with 35% biosimilar penetration |
Growing biosimilar share, poised for expansion |
| Price discount at launch |
15-30% below reference |
Incentivizes switching from branded biologic |
| Long-term discounts |
Up to 50-60% |
Significant cost savings for payers and providers |
| Competition |
Multiple biosimilars entering the market |
Pressure on prices and margins |
Key Takeaways
- The biosimilar corresponding to NDC 13668-0189 entered a growing, highly competitive market.
- Current prices are approximately 20-30% below the reference biologic.
- Price reductions are likely to continue, reaching up to 50% off by 2025.
- Market adoption depends on payer contracts, physician acceptance, and policy developments.
- Long-term price stability will depend on biosimilar market saturation and regulatory environment.
FAQs
1. What factors influence the pricing of biosimilars like NDC 13668-0189?
Market competition, payer negotiations, regulatory policies, and manufacturing costs impact biosimilar prices.
2. How does biosimilar price decline compare to small-molecule generics?
Biosimilars generally see slower and less drastic price declines due to higher development costs and complex manufacturing, but discounts tend to be substantial, reaching 50% off within a few years.
3. What is the typical market share of biosimilars in biologic treatments?
Biosimilars hold approximately 35% of infliximab prescriptions in the U.S., with potential to increase to over 60% by 2025.
4. How do regulatory policies affect biosimilar pricing?
Policies that facilitate interchangeability and promote cost-effective procurement support lower prices.
5. Are future price increases likely for biosimilars?
Future increases are unlikely; biosimilar prices tend to stabilize or decline with increased competition and market saturation.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- U.S. Food and Drug Administration. (2019). Biologic Price Competition and Innovation Act.
- EvaluatePharma. (2023). Biologic and biosimilar market forecast.
- CMS. (2022). Medicare Part B biosimilar policies.
- Subramanian, R., & Salvato, R. (2021). Price dynamics of biosimilar markets. Journal of Managed Care & Specialty Pharmacy, 27(9), 1059-1065.
