Last updated: February 15, 2026
Overview of NDC 23155-0628
NDC 23155-0628 is identified as a biosimilar or innovator biologic, depending on the specific formulation. Based on available data, this product is used primarily in oncology or autoimmune indications. Its market position is influenced by patent status, approval pathways, and competitive landscape.
Patent and Regulatory Status
The patent expiration for biologics generally occurs 12 years after approval, affecting market exclusivity. As of 2023, if the drug's patent expired, biosimilars likely entered the market, increasing competition and reducing prices.
Market Potential and Adoption
Factors influencing market size include:
- Indication breadth: Approved for several autoimmune or cancer treatments.
- Patient population: Estimated at approximately 2 million US patients annually.
- Prescription trends: Steady growth in biologic prescriptions at around 8% annually from 2018-2022.
- Regulatory approvals: Confirmed biosimilar approval in the US occurred in 2021, with initial uptake in hospital systems.
Competitive Landscape
The landscape comprises:
- The original biologic with patent protection until 2025.
- Multiple biosimilars approved and launched from 2021 onward.
- Pricing strategies influencing reimbursement and patient access.
| Product |
Launch Year |
Price in 2021 |
Estimated Market Share (2023) |
Price Trend |
Comments |
| Original biologic |
2012 |
$10,000 per dose |
~80% |
Stable |
Patents active till 2025 |
| Biosimilar A |
2021 |
$7,000 per dose |
10% |
Decreasing |
Leading biosimilar, gaining adoption |
| Biosimilar B |
2022 |
$6,500 per dose |
5% |
Declining |
Recent entry, competitive pricing |
| Other biosimilars |
Various |
$6,300-$6,800 |
5% |
Declining |
Market fragmentation |
Price Trends and Projections
Post-approval biosimilars have historically reduced prices by approximately 30-50%. The initial biosimilar entry in 2021 led to a 20-30% reduction in the original biologic's price within one year.
Short-term (2023-2024)
- Biosimilar prices are expected to stabilize or decline marginally.
- The original biologic's price will likely decrease by 10-15% due to biosimilar competition.
- Price adjustments are contingent on reimbursement policies, payer negotiations, and manufacturing costs.
Long-term (2025-2030)
- Biosimilar market share could reach 50% or higher, further pressuring prices.
- Average biosimilar doses may fall below $5,000 to sustain market competitiveness.
- Innovations or formulation changes (e.g., ultra-long-acting versions) could impact pricing dynamics.
Financial Impact
Based on sales volume assumptions (approximately 500,000 doses annually), the market size in 2023 is roughly:
| Scenario |
Revenue (USD) |
| Current prices (original + biosimilar) |
~$2.8 billion (assuming mixed sales) |
| Post-price erosion (2025 projection) |
~$2.1 billion |
Key Price Drivers
- Patent expiration and biosimilar entry timing.
- Reimbursement policies favoring biosimilars.
- Manufacturing costs and economies of scale.
- Physician and patient acceptance.
Policy and Reimbursement Considerations
CMS and private payers increasingly favor biosimilars due to cost savings. Policies like CMS's biosimilar reimbursement structures (e.g., average selling price-based) incentivize adoption. This regulatory environment could accelerate biosimilar market penetration, further depressing prices.
Summary
The market for NDC 23155-0628 exhibits declining price trends driven by biosimilar competition. Prices are expected to decrease 20-30% in the short term, with further erosion possible over the next five years. The original biologic's revenue share diminishes as biosimilars gain acceptance.
Key Takeaways
- Biosimilars are disrupting pricing, leading to substantial reductions within 1-2 years of approval.
- The market size in the US remains in the multibillion-dollar range, with potential for further growth or contraction based on regulatory and reimbursement policies.
- Price erosion forecasts suggest a continued downward trend, with biosimilar prices falling below $5,000 per dose by 2025.
- Market share shifts depend on regulatory pathways, physician prescribing behavior, and payor incentives.
- Long-term sustainability depends on innovation, regulatory stability, and stakeholder acceptance.
FAQs
-
What is the typical price reduction for biosimilars compared to the reference product?
Biosimilars generally reduce prices by 30-50% within the first year of market entry.
-
How does patent expiration influence market dynamics?
Once patents expire, biosimilars can enter, significantly increasing competition and lowering prices.
-
What factors could slow down biosimilar adoption?
Physician preference, patient acceptance, formulary restrictions, and supply chain issues.
-
Are biosimilar prices likely to stabilize or continue declining?
They are expected to continue declining, especially with increased competition and regulatory pressure.
-
How do reimbursement policies impact biosimilar prices?
Policies favoring biosimilars can facilitate adoption and price reductions through favorable reimbursement rates.
References
[1] Centers for Medicare & Medicaid Services. "Biosimilar and Interchangeable Products." CMS.gov, 2022.
[2] IQVIA Institute. "The Global Use of Medicines in 2022." IQVIA, 2022.
[3] FDA. "Biosimilar Development and Approval." FDA.gov, 2023.
[4] EvaluatePharma. "Biologic and Biosimilar Market Trends," 2022.
