Last updated: March 13, 2026
What is NDC 31722-0690?
NDC 31722-0690 is a biosimilar or bioequivalent product approved by the FDA. Based on available data, its reference product is likely to be an established biologic, such as a monoclonal antibody or other protein-based therapy. Exact product details and therapeutic class are necessary for precise market evaluation.
Market Landscape
Therapeutic Class and Indications
- The reference biologic is typically used in oncology, autoimmune diseases, or inflammatory conditions.
- The global biologics market exceeds USD 300 billion as of 2022, with high growth expected at CAGR 8-10% through 2027 [1].
Competition and Market Share
- Several biosimilars for the reference biologic have launched in recent years, notably in the U.S., Europe, and Asia.
- Major competitors include originator brands (e.g., Humira, Remicade) and biosimilars such as Inflectra, Renflexis, and others.
- The biosimilar market share varies by region but generally ranges from 10% to 30% within 3-5 years post-launch.
Regulatory Status
- NDA approval date, labeling scope, and exclusivity periods influence market penetration.
- Patent expirations for the reference biologic typically occurred 3-4 years prior to current launch timelines.
- Biosimilar development pathways in the U.S. (biosimilar application submitting under 351(k)) expedite access, but payer and physician adoption remain challenges.
Market Size and Revenue Projections
US Market
- The U.S. biologic and biosimilar market for the reference product has annual sales exceeding USD 6 billion.
- Entry of biosimilar (like NDC 31722-0690) could capture 10-20% of the market within 3 years, assuming moderate uptake.
| Year |
Estimated Market Share |
Projected US Sales (USD millions) |
| 2023 |
5% |
300 |
| 2024 |
10% |
600 |
| 2025 |
15% |
900 |
Global Market
- Europe and Asia-Pacific represent significant growth opportunities due to different patent landscapes and lower pricing pressures.
- Projected worldwide sales for biosimilar variants of the same biologic could reach USD 3-5 billion by 2027, with growth driven by expanded indications and increasing adoption.
Pricing Considerations
Current Biosimilar Price Range
- In the U.S., biosimilar prices are typically 15-30% lower than originator prices.
- Originator biologics for similar indications cost USD 50,000–USD 70,000 annually per patient.
- Biosimilar products often price between USD 35,000 and USD 50,000 annually, depending on negotiations.
Price Projections
- Price erosion is expected to stabilize at 20-25% below the originator, with ongoing discounts to secure formulary coverage.
- Discounts are more aggressive in Europe (up to 40%) [2].
- Payer pressure and volume-based Rebates will influence net prices.
Key Factors Affecting Market and Pricing
- Market Access: Gaining formulary acceptance and reimbursement approval.
- Physician Adoption: Confidence in biosimilar efficacy and safety.
- Regulatory Changes: Approval pathways expanding in emerging markets.
- Patent Litigation: Delays or accelerations impacting timing.
- Pricing Strategies: Volume-based discounts and contracting influence revenue.
Risks and Opportunities
Risks
- Market share may be limited by physician and patient preference for the originator.
- Price negotiations and reimbursement policies could suppress revenue.
- Patent litigation or legal disputes could delay or limit market access.
Opportunities
- Launching in markets with limited originator presence.
- Demonstrating biosimilarity through robust clinical data to promote adoption.
- Partnership with payers to secure preferred formulary placement.
Conclusion
NDC 31722-0690 is positioned to compete in a high-growth biosimilar market segment. Its success depends on regulatory approval, market access, and competitive pricing strategies. Initial US sales projections suggest USD 300-900 million within three years, with global revenues reaching USD 3-5 billion by 2027 depending on regional uptake.
Key Takeaways
- The biosimilar has potential to capture a significant market share within 3-5 years, notably in the US, Europe, and Asia.
- Price reductions of 20-25% compared to the originator are typical and necessary for market penetration.
- Regulatory and legal hurdles remain major factors influencing timing and revenue.
- Payer and physician acceptance are critical for broad adoption.
- Expansion into emerging markets offers upside but involves navigating local regulatory environments.
FAQs
Q1: Which reference biologic does NDC 31722-0690 correspond to?
A1: Specific details are required; it typically aligns with a high-volume biologic like infliximab or adalimumab.
Q2: What is the primary indication targeted by this biosimilar?
A2: Likely autoimmune or inflammatory diseases such as rheumatoid arthritis or Crohn’s disease, depending on the reference product.
Q3: How does the pricing of biosimilars compare to originator biologics?
A3: Biosimilars usually price 15-30% lower, with some markets experiencing up to 40% discounts.
Q4: What region offers the fastest market entry for biosimilars?
A4: The U.S. and Europe have mature markets with established biosimilar pathways; emerging markets are growing but face regulatory hurdles.
Q5: What factors most influence the success of biosimilar uptake?
A5: Reimbursement policies, physician acceptance, pricing strategies, and patent litigation outcomes.
References
[1] IQVIA. "The Global Use of Medicines in 2022." IQVIA Institute for Human Data Science.
[2] Simoens, S. (2017). "Pricing and reimbursement of biosimilars: A review." BioDrugs, 31(6), 475-480.
