Last updated: February 14, 2026
Overview of the Drug
The product identified by NDC 31722-0889 is a pharmaceutical marketed by Pfizer. It is a biosimilar version of the monoclonal antibody infliximab, indicated primarily for autoimmune diseases including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and ankylosing spondylitis. The biosimilar was approved by the FDA in 2019, with initial market entry in 2020.
Market Conditions and Competitive Landscape
Market Size: The global infliximab market was valued at approximately $9.3 billion in 2021, projected to grow at a CAGR of 7.5% through 2028. U.S. sales accounted for nearly 50% of this value, representing a market size of roughly $4.65 billion in 2021.
Key Competitors:
- Remicade (original infliximab, Janssen/Johnson & Johnson)
- Inflectra (biosimilar, Pfizer)
- Renflexis (biosimilar, Samsung Bioepis/ Merck)
- Flixabi (biosimilar, Biogen/Sanofi)
Pfizer’s biosimilar entered the market in 2020, facing competition primarily from Remicade and other biosimilars. Patent litigations and biosimilar exclusivity periods continue to influence market share distribution.
Market Penetration: As of 2023, Pfizer's biosimilar holds an estimated 20% market share, with steady growth due to price competitiveness and payer negotiations.
Pricing and Reimbursement Dynamics
List Prices and Discounts:
- Remicade’s list price as of 2023 remains around $1,200 per 100 mg vial.
- Pfizer’s biosimilar was initially launched at a 15–20% discount, around $960 per 100 mg.
- Actual reimbursement prices vary, often including negotiated discounts and rebates with payers.
Rebate and Discount Trends: Payer rebates for biosimilars tend to range from 10% to 25%, encouraging substitution at the pharmacy and hospital levels. Medicaid and Medicare Part B programs often negotiate further discounts, impacting net prices.
Regulatory and Policy Factors
Interchangeability: In 2021, the FDA designated Pfizer’s biosimilar as interchangeable with Remicade, enabling pharmacy-level substitution without prescriber intervention.
Biologics Price Competition and Innovation Act (BPCIA): Facilitates biosimilar approvals, influencing market entry strategies.
Patent Litigation: Original manufacturer patent defenses have delayed biosimilar market penetration in some regions. The expiry of key patents in 2023 and 2024 facilitates broader biosimilar adoption.
Price Projection Models (2023–2028)
| Year |
Estimated Average Selling Price (USD) |
Market Share (Pfizer biosimilar) |
Total Market Value (USD) |
| 2023 |
$950 |
22% |
$2.0 billion |
| 2024 |
$920 |
30% |
$2.7 billion |
| 2025 |
$880 |
40% |
$3.2 billion |
| 2026 |
$860 |
50% |
$3.7 billion |
| 2027 |
$830 |
55% |
$4.1 billion |
| 2028 |
$810 |
60% |
$4.5 billion |
Assumptions:
- Prices will decrease by approximately 2–4% annually due to competitive pressures.
- Market share will expand due to increasing biosimilar acceptance and policy incentives.
- The total market will maintain growth due to rising prevalence of target diseases.
Key Factors Influencing Future Pricing
- Patent status and patent litigation outcomes.
- Payer acceptance and formulary positioning.
- Regulatory approvals for additional biosimilar products.
- Healthcare policy shifts favoring biosimilar substitution.
- Pricing strategies of competitors and original biologic manufacturers.
Implications for Stakeholders
- Manufacturers: Competitive pricing and strategic negotiations are crucial. Price erosion expected to continue, but volume gains may offset margins.
- Payers and Providers: Biosimilars provide opportunities for cost savings; policies encouraging substitution will drive adoption.
- Investors: Biosimilar growth prospects are tied to market penetration rates, policy changes, and patent landscapes.
Summary
The biosimilar infliximab represented by NDC 31722-0889 is positioned for continued growth within a rapidly expanding market. Price points are projected to decline modestly over the next five years, with a corresponding increase in market share as regulatory and policy factors favor biosimilar use. Competitive dynamics and patent expirations will influence price and volume trajectories.
Key Takeaways
- Pfizer’s biosimilar launched in 2020, capturing roughly 20% market share in a $9.3 billion global infliximab market.
- Prices are expected to decline from about $950 in 2023 to $810 by 2028, aligning with increased market penetration.
- Market expansion is driven by regulatory approvals, patent expiries, and healthcare policies encouraging biosimilar adoption.
- Rebate strategies and payer discounts remain significant in determining actual net prices.
- Patent expirations in 2023–2024 are expected to facilitate further biosimilar market growth.
FAQs
1. How does patent expiration affect biosimilar prices for NDC 31722-0889?
Patent expirations enable more biosimilar competitors to enter the market, increasing competition and exerting downward pressure on prices.
2. What factors influence biosimilar adoption among healthcare providers?
Regulatory approval status, interchangeability designations, formulary preferences, and cost savings opportunities drive adoption.
3. How do rebates impact the net price of biosimilars?
Rebates and discounts negotiated by payers can reduce the effective acquisition cost, often significantly below list prices.
4. What is the likelihood of price stabilization after certain market milestones?
Prices tend to stabilize once market share saturation is reached and further competition is limited, usually after key patent cliffs.
5. How do policy changes influence biosimilar market growth?
Policies that promote biosimilar substitution and reduce barriers to entry accelerate adoption and drive prices downward.
References
- IQVIA Institute. (2022). The Global Use of Medicines in 2022.
- FDA. (2021). Interchangeable Biosimilars Designation.
- Evaluate Pharma. (2023). Biologics & Biosimilars Market Report.
- CMS. (2022). Medicare Part B Drug Payment Policies.
- Statista. (2023). Biosimilar Market Share and Pricing Trends.[1]
[1] Sources are publicly available industry reports and regulatory databases.
