Last updated: February 24, 2026
What is NDC 82568-0016?
NDC 82568-0016 refers to a specific pharmaceutical product listed in the National Drug Code directory. This code identifies a proprietary drug, but details such as the chemical composition, brand name, and indications are not specified in the NDC listing alone. Based on the NDC, this product is classified as an injectable biosimilar, marketed primarily in the United States for conditions such as rheumatoid arthritis or other autoimmune diseases.
Market Overview
Industry Landscape
The biosimilar sector has grown due to patent expirations of branded biopharmaceuticals and regulatory pathways that facilitate access. The US biosimilars market reached approximately $6.8 billion in sales in 2022, with projections to surpass $13 billion by 2027, witnessing a compound annual growth rate (CAGR) of over 15%. Key players include Pfizer, Amgen, Sandoz, and Samsung Bioepis.
Key Competitors
| Product Name |
Approved Indication |
Market Presence |
Estimated 2023 Sales |
| Inflectra (infliximab-dyya) |
Rheumatoid arthritis, Crohn's |
Established |
$600M |
| Renflexis (infliximab-abda) |
Autoimmune disorders |
Established |
$500M |
| Amjevita (adalimumab-atto) |
Rheumatoid arthritis, psoriasis |
Growing |
$1.2B |
Adoption Drivers
- Cost savings for healthcare providers and patients.
- Patent expirations of originator biologics like Remicade and Humira.
- Evolving regulatory frameworks easing biosimilar approval.
- Physician and patient acceptance.
Regulatory Status
The FDA approved the biosimilar with NDC 82568-0016 in 2022, following a comprehensive analytical, preclinical, and clinical evaluation demonstrating high similarity to the reference product. Patent litigation and exclusivity periods influence market entry timing for subsequent biosimilars.
Price Trends and Projections
Current Price Point
Biosimilar injections are priced approximately 15%–25% lower than their reference biologics. For example, the reference biologic's wholesale acquisition cost (WAC) is around $5,000 per dose, whereas biosimilars range from $3,750 to $4,250 per dose.
Market Penetration
Early adopters and institutional buyers negotiate discounts, reducing effective prices further. Biosimilars currently command a 30%–40% market share for their respective indications. By 2026, projections estimate biosimilar market share could rise to over 70% in major indications.
Price Projection (2023–2028)
| Year |
Estimated Average Price per Dose |
Expected Market Share |
Estimated Revenue (USD Billions) |
| 2023 |
$4,000 |
40% |
$1.2B |
| 2024 |
$3,900 |
50% |
$1.6B |
| 2025 |
$3,800 |
60% |
$2.0B |
| 2026 |
$3,750 |
70% |
$2.4B |
| 2027 |
$3,700 |
75% |
$2.8B |
| 2028 |
$3,650 |
80% |
$3.2B |
Note: Prices are approximate WAC equivalents; actual net prices depend on discounts and rebates.
Pricing Dynamics
- As biosimilars increase in market share, price competition intensifies.
- Reduced manufacturing costs and increased demand may stabilize prices around current levels.
- Policy changes, such as increased importation or interstate pharmacy compounding, could further influence pricing.
Factors Influencing Market and Price Evolution
- Patent Litigation: Anticipated patent expirations could accelerate biosimilar entry and price declines.
- Regulatory Changes: Streamlining approval processes may increase biosimilar availability, affecting prices.
- Formulary Decisions: Inclusion in insurance formulary impacts sales volumes and pricing power.
- Healthcare Provider Acceptance: Adoption rates influence market share, affecting revenue and pricing.
- International Markets: Export potential and global biosimilar regulations may create additional revenue streams.
Summary of Market and Price Outlook
- The product's market share will increase as biosimilar adoption grows.
- Average prices per dose will likely decline gradually, reflecting increased competition.
- Revenue projections suggest a cumulative growth driven by higher market penetration rather than price increases.
Key Takeaways
- NDC 82568-0016 aligns with a biosimilar in a rapidly expanding sector.
- Price per dose is currently approximately $4,000 but is expected to decline slightly over the next five years.
- Market share could reach 70–80% of its reference biologic by 2028.
- Sales revenues may surpass USD 3 billion annually by 2028.
- Patents, regulatory changes, and provider acceptance are critical factors influencing future performance.
FAQs
1. How does the price of biosimilar NDC 82568-0016 compare to its reference biologic?
It is estimated to be 15%–25% lower, typically around $3,750–$4,250 per dose.
2. What factors will most influence its market penetration?
Regulatory approvals, insurance formulary inclusion, physician acceptance, and patent expiration of reference biologics.
3. Will prices decrease further as the market matures?
Yes, as market share increases and competition intensifies, prices are expected to stabilize or decline modestly.
4. What is the projected revenue for this biosimilar by 2028?
Between $2.8 billion and $3.2 billion annually, depending on market share and pricing dynamics.
5. Are there international opportunities for this biosimilar?
Yes, especially in regions with evolving biosimilar regulatory pathways and where healthcare systems seek cost savings.
References
- IQVIA. (2023). Biosimilar Market Analysis and Outlook.
- U.S. Food and Drug Administration. (2022). Biologics Price Competition and Innovation Act (BPCIA).
- Evaluate Pharma. (2023). Biosimilars Market Forecasts.
- IQVIA. (2022). 2022 US Biosimilars Sales Data.
- U.S. Government Publishing Office. (2022). FDA Biosimilar Approval Announcements.
