Last updated: March 13, 2026
What is NDC 81952-0132?
NDC 81952-0132 corresponds to a biosimilar drug, specifically a biosimilar to Remicade (infliximab). The medication targets autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.
Market Landscape
Size and Growth
The global infliximab market was valued at approximately $7.8 billion in 2022 and is projected to reach $12.4 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of 7.8% (Fortune Business Insights, 2022).
Key Competitive Players
- Original biologic: Janssen's Remicade
- Biosimilars: Byooviz, Inflectra, Renflexis, and others
- Leading biosimilar developers: Celltrion, Samsung Bioepis, Pfizer, and Sandoz
Regulatory Timeline
- FDA approval: The biosimilar matching NDC 81952-0132 was approved in late 2020.
- Patent expiry of the reference drug (Remicade): 2018–2019, opening market opportunities.
Market Drivers
- Patent expiration of Remicade
- Increasing adoption of biosimilars for cost savings
- Growing prevalence of autoimmune disorders
- Increasing healthcare expenditure in developed and emerging markets
Price Dynamics and Projections
Current Pricing
The wholesale acquisition cost (WAC) for biosimilars like the one associated with NDC 81952-0132 ranges from $750 to $950 per dose, compared to approximately $3,000–$4,000 for the reference biologic, depending on dosage and region.
Price trends
- Biosimilar prices initially discount the reference biologic by 15–35%.
- Prices tend to stabilize after market entry, with marginal decreases driven by competition.
- Discount rates vary by country; for example, Europe often sees higher discounts (up to 40%) compared to the U.S.
Future Price Projections
- By 2025, biosimilar infliximab prices are expected to decline by an additional 10–20%, reaching WAC levels of $600–$800 per dose.
- Continued market entry of new biosimilars may further reduce prices by 15–25% over the next four years.
- Price erosion will be more significant in regions with health system volume-based purchasing, e.g., Europe and Asia.
Revenue Potential
| Year |
Estimated Market Size (USD, billions) |
Biosimilar Volume Share |
Approximate Revenue for Biosimilar Drugs |
| 2022 |
7.8 |
15% |
$1.17 billion |
| 2024 |
10.2 |
25% |
$2.55 billion |
| 2028 |
12.4 |
40% |
$4.96 billion |
Assumes increased biosimilar penetration driven by price sensitivity and regulatory approvals.
Regulatory and Reimbursement Influences
- U.S.: CMS promotes biosimilar adoption via fee-for-service incentives.
- EU: Several countries have mandated biosimilar substitution policies, boosting uptake.
- Reimbursement policies impact affordability and access, directly affecting market share.
Risks and Barriers
- Patent litigations involving biosimilar manufacturers.
- Physician and patient hesitance.
- Regulatory adjustments affecting approval timelines or interchangeability status.
- Supply chain disruptions, especially in initial deployment phases.
Strategic Recommendations
- Optimize pricing strategies based on regional regulatory environments.
- Invest in marketing efforts aimed at physicians and payers to increase acceptance.
- Strengthen supply chain logistics to ensure consistent availability.
- Monitor patent landscapes for potential legal challenges or opportunities.
Key Takeaways
- The biosimilar corresponding to NDC 81952-0132 is positioned in a rapidly growing segment of autoimmune disease treatment.
- Average biosimilar prices are 15–35% lower than the originator, with further declines anticipated.
- Revenue potential increases with market penetration, projected to reach nearly $5 billion globally by 2028.
- Regional pricing and reimbursement policies significantly influence market dynamics.
- Competitive landscape shifts hinge on patent protections, regulatory pathways, and physician adoption.
FAQs
Q1: When did the biosimilar for NDC 81952-0132 receive FDA approval?
A1: The biosimilar was approved in late 2020.
Q2: Which regions will drive the most biosimilar infliximab adoption?
A2: North America and Europe are leading regions due to favorable reimbursement policies and established regulatory pathways.
Q3: What are major barriers to biosimilar market expansion?
A3: Patent litigations, physician hesitancy, regulatory hurdles, and supply chain issues.
Q4: How do prices for biosimilars compare internationally?
A4: Europe typically offers higher discounts (up to 40%) than the U.S., where discounts hover around 15–35%.
Q5: What is the expected trend in biosimilar pricing by 2025?
A5: Prices are expected to decline by an additional 10–20%, reaching about $600–$800 per dose in WAC terms.
References
- Fortune Business Insights. (2022). Global Biosimilar Market Size, Share & Industry Analysis. Retrieved from https://www.fortunebusinessinsights.com
- U.S. Food and Drug Administration. (2020). Approval letter for infliximab biosimilar. Retrieved from https://www.fda.gov
- IQVIA. (2022). The Future of Biosimilar Markets in Europe and North America. Retrieved from https://www.iqvia.com
