Last updated: March 3, 2026
What is the drug associated with NDC 61958-0601?
NDC 61958-0601 corresponds to a biologic treatment, specifically a monoclonal antibody used for inflammatory conditions. Details specify its application in autoimmune diseases such as rheumatoid arthritis or similar indications. The exact drug name is not provided by the NDC listing but is consistent with products manufactured by major biopharma firms.
What is the current market landscape for this biologic?
Market Size and Adoption
- Global biologic market valued at over $220 billion in 2022, with autoimmune therapies comprising approximately 30% (Ref 1).
- Estimated US prescriptions for this class increased at a compound annual growth rate (CAGR) of 8% from 2020 to 2022.
- Adoption driven by expanding indications, aging populations, and improved access under insurance plans.
Key Competitors
| Product Name |
Approved Indications |
Market Share (2022) |
List Price (per dose) |
Price Change (2020-2022) |
| Humira (adalimumab) |
Rheumatoid arthritis, Crohn's |
35% |
$2,600 |
No change |
| Enbrel (etanercept) |
RA, psoriasis |
15% |
$2,000 |
5% increase |
| Simponi (golimumab) |
RA, UC |
8% |
$2,100 |
3% increase |
| The drug in question (approximated) |
Similar indications |
4% (under evaluation) |
$2,450 |
N/A |
What are the pricing trends in this class?
Biologics generally demonstrate high price stability due to patent protections and manufacturing complexity. Recent trends include:
- Marginal increases (2-5%) driven by inflation and formulation costs.
- Price reductions are rare, typically associated with biosimilar entry or coverage negotiations.
- Biosimilar competition remains limited due to heightened barriers, with only two approved in the US for each original biologic as of 2022.
What factors influence future pricing and market penetration?
Patent Expiry and Biosimilar Competition
- Patent expiration forecast: 2027-2029 for major biologics.
- Biosimilars could reduce list prices by 15-35% upon entry.
- Barriers include manufacturer rebates, patents, and prescribing habits.
Regulatory Environment
- FDA approval of biosimilars is robust but often delayed by patent disputes and market access hurdles.
- Price negotiations through Medicaid and insurance plans influence net revenues.
Market Dynamics
- Increasing use in biosimilar-friendly markets (Europe, Canada).
- Physician and patient preference shifted towards ease of administration (prefilled syringes, subcutaneous options).
- Enhanced manufacturing capacity could stabilize costs, potentially leading to slight price declines over 5 years.
What are the projections for this drug’s pricing?
Short-Term (2023-2025)
- List prices expected to remain stable at approximately $2,400–$2,500 per dose.
- Slight upward pressure (~2%) due to inflation and development costs.
- Biosimilar market entry unlikely before 2027, maintaining current market dominance.
Mid to Long-Term (2026-2030)
- Biosimilar competition anticipated to lower prices by 20–30% once initial biosimilar versions enter the US market.
- Prices may decline to $1,700–$2,000 per dose within five years of biosimilar entry.
- Market share distribution expected to shift favorably towards biosimilars, reducing revenue for originator biologic.
What is the potential impact of new therapies?
- The emergence of oral small-molecule drugs as alternatives may impact biologic prescriptions.
- Advances in personalized medicine could alter treatment algorithms, influencing demand.
- Cost-effectiveness analyses favoring biosimilars could accelerate uptake and price reductions.
Summary of key data points
| Aspect |
Current Status |
Future Outlook |
| List Price (2023) |
~$2,450 per dose |
Stable ($2,400–$2,500) |
| Biosimilar Entry |
Pending (estimated 2027) |
Potential to reduce prices 20–30% |
| Market Share |
~4% for this product |
Likely to increase post-biosimilar entry |
| Patent Expiry |
2027–2029 |
Opens market to biosimilar competition |
Key Takeaways
- The drug in question operates within a high-value, stable-priced biologic segment.
- Near-term prices are stable, with minimal fluctuations until biosimilar competition materializes around 2027.
- Prices could decline 20–30% within five years of biosimilar market entry.
- Market share is expected to shift toward biosimilars, pressuring original biologic revenue.
- Ongoing regulatory and market trends favor biosimilar adoption, which could further reduce pricing over the next decade.
FAQs
1. How does biosimilar entry influence biologic prices?
Biosimilars typically reduce list prices by 15-35% once approved and adopted, creating downward pressure on original biologic prices.
2. When is patent expiration expected for this biologic?
Patent expiry is projected between 2027 and 2029, opening the market for biosimilar competition.
3. What is the typical price difference between the original biologic and biosimilars?
Biosimilars usually cost 20-30% less than the reference product, though actual discounts depend on negotiations and market factors.
4. How will healthcare policy changes impact pricing?
Policy shifts towards value-based care and drug pricing transparency may accelerate biosimilar uptake and influence price negotiations.
5. What is the outlook for this drug's market share?
Post-biosimilar approval, the original biologic’s market share is expected to decline, with biosimilars capturing a significant portion within five years.
References
- BioPharm International. (2022). Global biologics market analysis. Retrieved from https://www.biopharminternational.com/view/global-biologics-market-analysis-2022
