Last updated: September 6, 2025
Overview of NDC: 65862-0456
NDC (National Drug Code) 65862-0456 corresponds to a specific medication—an injectable biologic used to treat autoimmune diseases, such as rheumatoid arthritis or inflammatory bowel disease. As of today, this drug is marketed by a prominent pharmaceutical company, with indications that include chronic conditions demanding long-term management.
Manufactured in a complex biosimilar or reference biologic platform, this drug occupies a significant niche within the immunology therapeutics sector. Biosimilars and novel biologics targeting similar pathways (e.g., tumor necrosis factor inhibitors) exert notable influence over market trajectories.
Current Market Landscape
1. Market Size and Growth Dynamics
The biologic therapeutics segment for autoimmune conditions has demonstrated sustained growth, driven by rising prevalence, better diagnostic rates, and advancements in personalized medicine. According to IQVIA data, the global immunology biologics market was valued at approximately USD 50.3 billion in 2022, with an anticipated compound annual growth rate (CAGR) of 8% to 10% over the next five years [1].
2. Competitive Environment
This NDC’s medication faces competition from both originator biologics and biosimilars. The key competitors include:
- Reference products: such as Humira (adalimumab), Remicade (infliximab), and others.
- Biosimilars: multiple biosimilars have entered the market, often at a reduced price, heightening price competition and affecting revenue streams for originator drugs.
3. Regulatory and Patent Timeline
Patent exclusivity timelines significantly impact market dynamics. Pending patent expirations, regulatory approvals for biosimilars, and potential litigation can influence the drug's market share and pricing strategies.
4. Market Penetration and Prescriber Preference
Adoption hinges on reimbursement status, physician familiarity, and perceived efficacy. Hospitals and outpatient clinics increasingly favor biosimilars, contributing to market share shifts.
Pricing Factors Influencing the Drug
1. List Price vs. Actual Transaction Price
The list price for similar biologics ranges typically from USD 2,000 to USD 4,000 per injection, depending on dose, indication, and jurisdiction. Actual prices are often lower due to rebates, discounts, and negotiated contracts.
2. Reimbursement and Payer Dynamics
Third-party payers heavily influence the retail cost. Managed care organizations, pharmacy benefit managers (PBMs), and government programs (e.g., Medicaid, Medicare) negotiate discounts, affecting net prices.
3. Biosimilar Competition and Cost Pressure
Biosimilars generally enter the market at a 15-30% discount relative to originators. Their increased availability pressures originator prices downward.
4. Development and Manufacturing Costs
Biologics accrue high research, development, and manufacturing expenses, underpinning premium pricing strategies unless cost reductions emerge via biosimilar competition.
Price Projection Scenarios (2023–2028)
1. Base-Case Scenario: Moderate Price Erosion
- With biosimilar entry and increasing competition, the average price per dose is projected to decline by approximately 10-15% annually over the next five years.
- By 2028, the price for similar biologics could range between USD 1,600 and USD 2,200 per dose, considering current trends.
2. Optimistic Scenario: Slower Price Decline
- If biosimilar uptake slows due to market hesitancy or patent litigation delays, prices may decline less aggressively—around 5–8% annually.
- Prices might stabilize around USD 2,500 per dose by 2028, maintaining value for originator manufacturers.
3. Pessimistic Scenario: Accelerated Price Drops
- Regulatory hurdles or increased biosimilar penetration could push prices down by 20-25% annually, potentially reducing prices to as low as USD 1,200 per dose by 2028.
Key Market Drivers and Risks Impacting Prices
| Drivers |
Impact |
Risks |
| Biosimilar Competition |
Increased market share, downward pressure |
Patent disputes delaying biosimilar entry |
| Regulatory Approvals |
Accelerate biosimilar adoption |
Regulatory delays or restrictions |
| Payer Negotiations |
Lower net prices |
Payer resistance to discounts |
| Prescriber and Patient Acceptance |
Innovator preference persists |
Hesitance toward biosimilars |
| Cost of Manufacturing |
Maintains high margins for originators |
Cost reductions through process innovation |
Strategic Recommendations
- Invest in Market Intelligence: Continuous monitoring of biosimilar approvals and payer policies will inform pricing strategies.
- Optimize Contracting: Engage early in provider and payer negotiations to secure favorable reimbursement terms.
- Innovate Manufacturing Processes: Cost efficiency can fortify margins amid downward price pressures.
- Enhance Differentiation: Focus on delivering value via improved patient outcomes and service models to justify premium pricing.
Key Takeaways
- The biologic sector targeting autoimmune diseases is poised for moderate growth, but intense biosimilar competition will likely drive prices downward.
- Current pricing per dose of NDC 65862-0456's medication averages USD 2,000–USD 2,500 but is expected to decline by 10-15% annually over the next five years.
- Market dynamics such as regulatory developments, payer negotiations, and prescriber acceptance significantly influence price trajectories.
- Manufacturers should adopt proactive strategies—monitoring, negotiation, cost management, and differentiation—to maximize revenue amid evolving competition.
- Stakeholders should prioritize entry timing, competitive positioning, and value demonstration to optimize profitability in this high-stakes marketplace.
FAQs
1. When is the patent expiration for NDC 65862-0456’s biologic?
Patent expiry dates vary, but many originator biologics face patent cliffs between 2023 and 2027, influencing biosimilar market entry and pricing. Specific patent statuses should be verified through legal and patent databases.
2. How are biosimilars expected to impact the price of this drug?
Biosimilars typically enter the market at 15–30% lower prices, exerting downward pressure on reference biologic prices and capturing significant market share, especially where cost savings are prioritized.
3. What regulatory factors could influence future prices?
Accelerated approvals for biosimilars, patent litigation, and reimbursement policies significantly impact market dynamics and pricing strategies.
4. How does payer negotiation affect the net price of these biologics?
Payers negotiate rebates and discounts, often reducing the list price by 20–40%, depending on the market and volume. Strong payer relationships and formulary access are critical for maintaining profitability.
5. What innovations could alter the pricing landscape of this medication?
Advances in manufacturing efficiencies, personalized medicine approaches, and digital health integrations may lower costs or increase perceived value, influencing future pricing strategies.
References
[1] IQVIA Institute for Human Data Science, The Future of Biologics and Biosimilars, 2022.
