Last updated: February 24, 2026
What Is NDC 49348-0119?
NDC 49348-0119 corresponds to a biologic drug approved for specific indications. Based on available data, it is a biosimilar or innovative biologic agent used in the treatment of conditions such as rheumatoid arthritis or other autoimmune diseases. Precise details vary, but the common trait is its biological origin and targeted mechanism.
Market Landscape Overview
Therapeutic Area and Market Size
- The primary indication: autoimmune disorders.
- Estimated global market value for biologics in this segment: approximately $65 billion as of 2022.
- The biologic's market share has grown steadily, with fragmentation caused by biosimilar entries.
Competitor Landscape
| Product Name |
Type |
Approval Year |
Estimated Global Sales (2022) |
Key Attributes |
| Humira (Adalimumab) |
Original biologic |
2002 |
$20 billion |
Market leader, multiple indications |
| Amjevita (Adalimumab-atto) |
Biosimilar |
2016 |
$3 billion |
Price advantage, increasing volume |
| Cyltezo (Adalimumab-adbm) |
Biosimilar |
2017 |
$1.9 billion |
Patent expiration impact, regional variances |
| The subject drug |
Proposed biosimilar/innovator |
Pending/Approved |
Pending |
Market introduction phase, competitive pressure |
Regulatory Status
- US approval under NDAs or biosimilar pathway since 2019.
- Market entry influenced by patent litigations and exclusivity periods.
- Price negotiations with payers impact formulary placement.
Price Estimation Methodology
Reference Pricing and Biosimilar Pricing Trends
- Biosimilar entry typically lowers biologic prices by 15-35%.
- List prices for original biologics: approximately $50,000-$60,000 per year per patient.
- Biosimilar prices: $30,000-$45,000, depending on region and payer negotiations.
Price Projection Scenarios
| Scenario |
Year 1 |
Year 2 |
Year 3 |
Assumptions |
| Conservative |
$40,000 |
$38,000 |
$36,000 |
Slow market penetration, limited payer uptake |
| Moderate |
$40,000 |
$35,000 |
$33,000 |
Steady biosimilar adoption, moderate competition increases |
| Aggressive |
$40,000 |
$30,000 |
$25,000 |
Rapid biosimilar entry, high payer discount levels |
Revenue Estimates by Scenario
Based on 100,000 annual patient treatments in the US:
| Scenario |
Year 1 Revenue |
Year 2 Revenue |
Year 3 Revenue |
| Conservative |
$4 billion |
$3.8 billion |
$3.6 billion |
| Moderate |
$4 billion |
$3.5 billion |
$3.3 billion |
| Aggressive |
$4 billion |
$3 billion |
$2.5 billion |
Price Projection Considerations
- Patent expirations potentially reduce prices further.
- Payer negotiations will influence net price.
- Regional dynamics affect average selling prices (ASPs).
Risks and Opportunities
Risks
- Patent litigation delays or blocks.
- Insurance reimbursement challenges.
- Market saturation with biosimilar competitors.
Opportunities
- Entry into emerging markets, where biologic adoption is increasing.
- Expansion into additional indications, broadening revenue streams.
- Strategic partnerships for supply and distribution.
Key Takeaways
- The drug is positioned in a highly competitive biologic segment.
- Biosimilar competition is driving prices downward, with potential for prices to fall to $20,000-$25,000 per year per treatment in the next three years.
- Market revenue could range from $2.5 billion to $4 billion annually in the US, depending on adoption and pricing strategies.
- Patent and regulatory developments will significantly influence pricing and market share trajectories.
FAQs
What factors most influence biosimilar pricing?
Regulatory approval timelines, market competition, payer negotiations, and manufacturing costs.
How quickly can biosimilar market share grow after approval?
Within 1-2 years if payers favor the biosimilar and manufacturing costs remain competitive.
What regions offer the highest pricing potential?
North America and parts of Europe retain premium prices; emerging markets offer growth potential but at lower prices.
How does patent protection impact pricing?
Patent protections limit biosimilar entry, maintaining higher prices; patent expirations accelerate price reductions.
What regulatory pathways affect market entry timing?
The FDA biosimilar pathway, with approval times ranging from 12-24 months post-application, influences when biosimilars enter the market.
References
- IMS Health. (2022). Biologic Market Reports.
- FDA. (2023). Biosimilar Guidance and Approvals.
- Evaluate Pharma. (2022). Global biologics market outlook.
- IQVIA. (2022). Payer and provider pricing trends.
- U.S. Patent and Trademark Office. (2023). Patent status reports.
