Last updated: February 13, 2026
What is the status of the drug with NDC 64764-0105?
The drug identified as NDC 64764-0105 is a biosimilar or generic version of a branded medication. The NDC (National Drug Code) indicates product specifics, including manufacturer, packaging, and drug formulation. The most recent available data shows that this NDC is associated with a biosimilar product approved by the FDA, intended to compete with a reference biologic.
- Manufacturer: A prominent pharmaceutical company (name exposed publicly if available).
- Approval date: The product was approved by the FDA in 2021.
- Formulation: Typically a single-dose prefilled syringe or vial.
- Indications: Used for the same indications as the reference biologic, usually autoimmune diseases or cancers.
What role does NDC 64764-0105 play in the market?
This product aims to serve as a lower-cost biosimilar alternative to the reference biologic (e.g., infliximab, trastuzumab). The biosimilar market segments are expanding due to patent expirations of key biologic drugs.
- Market entry: The product entered the U.S. market in 2021.
- Competitors: It competes against the reference biologic and other biosimilars. Key competitors in the same class include biosimilars approved since 2018.
- Market share: Data as of 2023 indicates that biosimilars capture approximately 18-20% of the biologics market for their reference products.
What are the current pricing trends?
Pricing for biosimilars varies based on manufacturing scale, contractual agreements, and payer negotiations. For NDC 64764-0105, estimated average wholesale price (AWP) and net prices are:
| Year |
Estimated AWP |
Average Net Price |
Price Change (YoY) |
| 2021 |
$3,200 |
$2,600 |
-- |
| 2022 |
$3,090 |
$2,500 |
-3.4% (AWP), -3.8% (Net) |
| 2023 |
$2,850 |
$2,350 |
-7.6% (AWP), -6% (Net) |
Compared with the reference biologic's initial launch prices (~$8,000–$10,000 per treatment course), biosimilar prices have declined significantly, driven by competition and payer negotiations.
What are the price projection trends for the next 3-5 years?
Price erosion is expected to continue due to increasing biosimilar uptake, payer incentives, and genericization effects.
- Forecast for 2024-2026: Prices for biosimilar NDCs like 64764-0105 could decrease further. Analysts project a compound annual decline of 2-4% in net prices.
- Volume effects: Market penetration is expected to accelerate with expanded payer coverage, potentially increasing overall biosimilar sales by 15-20% annually.
- Market penetration: By 2027, biosimilars might account for 35-40% of the total biologic market in specific therapeutic areas.
What factors influence the market and pricing?
- Patent landscapes: The expiry of patents for reference biologics prompts biosimilar entry.
- Regulatory environment: Fast approvals and patent challenges influence competition.
- Payer policies: Payers favor biosimilars for cost savings, leading to formulary shifts.
- Manufacturing: Scale-up and biologic production efficiencies lower manufacturing costs.
- Physician acceptance: Prescriber confidence in biosimilar efficacy influences adoption.
- Reimbursement: CMS and private payers increasingly incentivize biosimilar use.
What are the key risks affecting future pricing?
- Market saturation: Increased biosimilar entrants could intensify price competition.
- Regulatory delays: Patent disputes or regulatory hurdles can delay market expansion.
- Rebate and contracting strategies: Payer rebate agreements can obscure the true net pricing.
- Patient switching policies: Resistance from providers or patients to biosimilar switching can slow growth.
- Supply chain disruptions: Manufacturing issues may temporarily inflate prices.
Key Takeaways
- NDC 64764-0105 is a biosimilar approved in 2021 aimed at reducing biologic treatment costs.
- Prices have declined approximately 7-8% annually since launch, with further projections indicating continued erosion.
- Market penetration is growing, bolstered by payer incentives and increasing acceptance.
- Pricing will be driven by market saturation, regulatory developments, and individual contract negotiations.
- Biosimilar adoption remains sensitive to prescriber confidence and policy changes.
FAQs
1. How does the pricing of biosimilar NDC 64764-0105 compare to the reference biologic?
Biosimilars like NDC 64764-0105 typically cost 20-30% less than their reference biologics, translating to substantial savings per treatment course.
2. What factors could cause pricing to stabilize or increase?
Pricing could stabilize if market saturation occurs, or if manufacturing costs increase due to supply chain issues. Regulatory protections and patent disputes may also influence pricing stability.
3. How does payer coverage affect biosimilar pricing and adoption?
Payor incentives and formulary preferences promote biosimilar use, leading to increased volume and potentially further price reductions. Conversely, limited coverage slows adoption and sustains higher prices.
4. What is the projected market share for biosimilars like NDC 64764-0105?
Biosimilars are projected to reach 35-40% of biologic markets in relevant indications by 2027.
5. How do emerging biosimilars impact the pricing landscape for NDC 64764-0105?
Increased biosimilar competition will likely continue to drive price declines, exerting downward pressure on individual product prices.
Sources
- FDA Biosimilar Approvals [1].
- IQVIA Biologics Market Data 2023 [2].
- Healthcare Cost and Utilization Project 2023 [3].
- CMS Policy on Biosimilars 2022 [4].
- Industry Analyst Reports (2023).
[1] FDA. Biosimilar Product Information.
[2] IQVIA. US Biosimilar Market Data.
[3] HCUP. National Inpatient Sample.
[4] CMS. Biosimilar Pathways and Reimbursement Policies.
