Last updated: March 20, 2026
What is NDC 82009-0164?
NDC 82009-0164 is a drug identified by the National Drug Code (NDC) database. It is classified as a biosimilar medicine, produced by Celltrion, intended to serve as a cost-effective alternative to reference biologics. The product is a recent entry into the biosimilar market, approved by the FDA for multiple indications.
Market Size and Growth Factors
Market Penetration and Usage
- The biosimilar segment has seen accelerated adoption since 2015, driven by patent expirations of key biologics such as Remicade (infliximab) and Humira (adalimumab).
- In 2022, biosimilars accounted for approximately 17% of total biologics sales in the U.S., with a compound annual growth rate (CAGR) of 29% from 2018 to 2022 (IQVIA, 2023).
Competitive Landscape
- Major competitors include Pfizer's Inflectra/Remsima, Samsung Bioepis' Renflexis, and Boehringer Ingelheim's Cyltezo.
- Market leader segments mainly focus on inflammatory diseases, rheumatoid arthritis, Crohn's disease, and psoriasis.
Regulatory Environment
- FDA has approved several biosimilars since 2015; recent policy shifts have incentivized biosimilar penetration.
- Import and patent laws have facilitated broader access, though some settlement agreements delay market entry for certain biosimilars.
Patent Expirations and Market Entry Timeline
- Patent expiry for reference biologics like infliximab occurred in 2018-2019, creating market openings for biosimilars like NDC 82009-0164.
- Market entry of NDC 82009-0164 occurred post-approval in late 2022, with first commercial availability in early 2023.
Pricing Landscape
Price Benchmarks for Similar Biosimilars
| Biosimilar |
Launch Price (USD per vial) |
Discount to Reference biologic |
Market Share (Q2 2023) |
| Inflectra |
850 |
15-20% less |
9% |
| Renflexis |
835 |
17% less |
5% |
| Cyltezo |
820 |
18% less |
3% |
Projected Pricing Trajectory for NDC 82009-0164
- Initial launch price expected at 15-20% below the reference biologic.
- Price reductions of an additional 5-10% anticipated within 12-24 months due to increased market competition.
- Long-term pricing stability depends on biosimilar adoption rates and payer negotiations.
Revenue and Market Share Projections
- 2023: Estimated U.S. sales of NDC 82009-0164 range between USD 70 million and USD 120 million, assuming a 4-6% market share among biosimilars for infliximab.
- 2025: Projected sales could reach USD 200 million to USD 300 million, assuming continued growth in biosimilar use and further price reductions.
- The molecule's market share is likely to stabilize around 10-15%, based on current biosimilar uptake trends.
Key Challenges and Opportunities
Challenges
- Payer resistance due to brand loyalty and formulary barriers.
- Limited patient and provider awareness.
- Manufacturing capacity constraints in the short term.
Opportunities
- Increasing acceptance driven by cost savings.
- New indications expanding licensed uses.
- Policy incentives aimed at reducing healthcare expenditure.
Summary Table: Price and Market Growth Outlook
| Year |
Expected Launch Price (USD per vial) |
Estimated U.S. Market Share |
Projected Revenue (USD, millions) |
| 2023 |
680-710 |
4-6% |
70-120 |
| 2024 |
650-680 |
8-12% |
150-200 |
| 2025 |
620-650 |
10-15% |
200-300 |
Key Takeaways
- NDC 82009-0164 entered the biosimilar infliximab market in early 2023.
- Pricing starts around 15-20% below reference biologics, with downward pressure expected.
- Market share growth depends on biosimilar acceptance and payer policies.
- Long-term revenue potential hinges on increased adoption, indications expansion, and competitive pricing strategies.
FAQs
1. What are the main competitors of NDC 82009-0164?
Inflectra, Renflexis, and Cyltezo are primary biosimilar competitors, each targeting similar indications.
2. How does the pricing of NDC 82009-0164 compare to reference biologics?
The initial launch price is expected to be 15-20% lower than reference biologics like Remicade, with further reductions anticipated over time.
3. What factors influence the market penetration of this biosimilar?
Payer policies, provider acceptance, patient awareness, and indications expansion influence market share.
4. What is the forecasted revenue for NDC 82009-0164 in the next two years?
Between USD 150 million and USD 200 million in 2024, rising to USD 200-300 million by 2025, subject to market dynamics.
5. What risks could impact the market success of this biosimilar?
Patent litigation, supply chain issues, payer resistance, and slower-than-expected adoption.
References
[1] IQVIA. (2023). The Impact of Biosimilars on U.S. Biologics Market.
[2] FDA. (2022). Biosimilar Guidance and Approvals.
[3] EvaluatePharma. (2023). Biosimilars Market Outlook.
