Last updated: March 3, 2026
What is NDC 60219-1748?
NDC 60219-1748 is a pharmaceutical product approved by the FDA. It is a biosimilar of reference products with specific therapeutic indications. The drug's chemical composition, manufacturing details, and approved uses are documented in its labeling and regulatory submissions.
Market Landscape
Therapeutic Area and Market Size
The drug targets a specific therapeutic area with an estimated global market value of approximately $X billion in 2023. A breakdown:
- US Market: $X billion, accounting for Y% of global sales.
- Europe: $X billion, with growth driven by biosimilar adoption.
- Asia-Pacific: $X million, with emerging adoption rates.
Key Competitors
Primary competitors include the reference biologic and other biosimilars:
| Product Name |
Manufacturer |
Year Approved |
Market Share (2023) |
| Reference Product |
[Name] |
[Year] |
X% |
| Biosimilar A |
[Name] |
[Year] |
Y% |
| Biosimilar B |
[Name] |
[Year] |
Z% |
Regulatory Status
- FDA approval date: [Date]
- Patent status: Patent expiry expected in [Year]
- Market entry barriers: Intellectual property protections, manufacturing complexity
Price Analysis
Current Pricing
- US: Listing price ranges from $X to $Y per unit depending on dosage and formulation.
- Europe: Price points are approximately €X, driven by national pricing regulations.
- Asia-Pacific: Prices tend to be lower, around $X, due to market competition and reimbursement policies.
Price Comparisons
| Product |
Price Per Dose |
Market Regulation Factors |
| Reference biologic |
$A |
Patented, high cost |
| Biosimilar A |
$B (-30%) |
Price competitiveness |
| Biosimilar B |
$C (-50%) |
Lower price point, lower adoption |
Projected Price Trends (Next 2-5 Years)
- Biosimilar price discounts are expected to decrease to 20-30% below reference biologic costs.
- Price reductions will be influenced by market competition, regulatory policies, and manufacturing scale.
- Price stabilization anticipated once biosimilar market penetration reaches approximately 50-60%.
Sales and Revenue Projections
Key Assumptions
- Biosimilar penetration rate increases at 10-15% annually.
- Price discounts remain stable or slightly decline.
- Reimbursement policies favor biosimilars, boosting adoption.
Revenue Outlook (Next 5 Years)
| Year |
Estimated Global Sales |
Growth Rate |
Notes |
| 2023 |
$X billion |
N/A |
Baseline |
| 2024 |
$X+B million |
Y% |
Increased adoption |
| 2025 |
$X+C billion |
Z% |
Market expansion |
Risks to projections
- Policy changes introducing stricter reimbursement or prescribing restrictions.
- Patent litigation delaying generic entry.
- Manufacturing bottlenecks affecting supply.
Strategic Insights
- Market entry timing is critical; early entries gain market share.
- Demonstrating biosimilar equivalence enhances physician trust.
- Competitive pricing and patient access programs improve uptake.
Key Takeaways
- NDC 60219-1748 operates in a competitive biosimilar market expected to grow driven by cost-containment policies.
- Pricing will remain competitive, with discounts of approximately 20-30% below reference biologics.
- The market will see increased adoption as biosimilar penetration increases, supporting revenue growth.
- Regulatory developments and patent status will influence timing and market dynamics.
FAQs
1. When did NDC 60219-1748 receive FDA approval?
The drug was approved on [Date].
2. What are the main competitors in its market?
The primary competitors are the reference biologic and biosimilars such as Biosimilar A and B.
3. How much is the current market for this drug?
Global sales are estimated at $X billion in 2023, with regional variances.
4. What factors could influence future price trends?
Market competition, regulatory policies, patent status, and manufacturing capacity.
5. What are the major risks to revenue growth?
Regulatory restrictions, patent litigations, and supply chain issues.
References
- [Source detailing FDA approval date and labeling]
- [Market size and growth projections]
- [Competitive landscape analysis]
- [Pricing data from public sources]
- [Regulatory and patent information]
