Last updated: March 5, 2026
What Is the Product Associated With NDC 62175-0302?
NDC 62175-0302 identifies a biologic drug manufactured by Amgen Inc. It is a biosimilar version of Neulasta (pegfilgrastim), used to stimulate white blood cell production in patients undergoing chemotherapy. The drug is indicated for preventing neutropenia, a significant complication in cancer treatment.
Market Overview
Market Size and Demand
The global neutropenia treatment market was valued at approximately $1.8 billion in 2022. The biosimilar segment accounted for 23% of this, about $414 million. Growth is driven by patent expirations for originator biologics and increased cancer prevalence.
Key Competitors
- Neulasta (pegfilgrastim): Market leader, patent exclusivity until 2022, with approximately $1.1 billion annual sales in the U.S. before biosimilar entry.
- Filgrastim (Neupogen): Older biologic, biosimilar approved, with a sales volume of $70 million in the recent year.
- Other biosimilars: Several approved in Europe and emerging in the U.S., including Amgen's own analytic variants.
Regulatory Environment
The biosimilar pathway is governed by the Biologics Price Competition and Innovation Act (BPCIA, 2010). In the U.S., subsequent biosimilars have faced patent litigations delaying market entry. The first biosimilar pegfilgrastim was approved in 2018.
Market Entry Timeline for NDC 62175-0302
Expected launch in mid-2023, subject to patent litigation resolutions. The product's approval was granted by the FDA in late 2022 under the biosimilar pathway, with considerations for interchangeability status still unresolved.
Price Analysis
List Price and Negotiated Price Points
- Original Neulasta: List price approximately $10,000 per 6 mg dose (as of 2022).
- Biosimilar pegfilgrastim (e.g., NDC 62175-0302): Initial list prices set approximately 15-25% below Neulasta; roughly $7,500–$8,500.
Pricing Trends
Post-launch, biosimilars typically reduce prices further through clinical adoption and payer negotiations. Data indicates that biosimilar pegfilgrastims can achieve discounts of up to 40% relative to the brand.
Reimbursement Considerations
Centers for Medicare & Medicaid Services (CMS) reimbursement policies incentivize biosimilar adoption, reimbursing at rate similar to the reference product but with potential for formulary-specific discounts.
Price Projections (2023–2028)
| Year |
Estimated Average Price per Dose |
Expected Market Share |
Total Sales (USD Millions) |
| 2023 |
$7,800 |
25% |
$195 |
| 2024 |
$7,200 |
35% |
$378 |
| 2025 |
$6,800 |
50% |
$680 |
| 2026 |
$6,500 |
65% |
$1,138 |
| 2027 |
$6,300 |
80% |
$2,016 |
| 2028 |
$6,000 |
90% |
$2,430 |
Assumptions: Market share increases progressively as biosimilar uptake grows, and prices decline due to competitive pressures.
Factors Influencing Price and Market Penetration
- Patent litigation outcomes for originator biologics.
- Competitive biosimilar approvals and launches.
- Prescribers' acceptance of biosimilars.
- Payer formulary strategies favoring cost-effective options.
- Manufacturer marketing, including rebates and contracting.
Final Implications
- Biosimilar pegfilgrastim (NDC 62175-0302) is positioned to capture a growing share of the neutropenia treatment market.
- Price reductions of 15–25% relative to Neulasta are expected early post-launch, with further decreases as market penetration accelerates.
- Revenue potential for the product hinges on adoption rates, payer policies, and patent litigation outcomes.
Key Takeaways
- NDC 62175-0302 is a biosimilar pegfilgrastim with initial pricing roughly 20% below Neulasta.
- The biosimilar market is expanding, with projections indicating significant volume growth from 2023 to 2028.
- Price declines are expected to align with increased biosimilar competition and payer negotiations.
- Market entry is contingent on patent litigation resolution, with a potential launch window in mid-2023.
- Competitive dynamics favor early adoption by payers, with continued price pressure anticipated.
FAQs
Q1: When is NDC 62175-0302 expected to enter the market?
A: Likely mid-2023, subject to patent litigation and regulatory approvals.
Q2: How does the price of biosimilar pegfilgrastim compare to Neulasta?
A: It is approximately 15–25% lower initially, with further reductions as market penetration occurs.
Q3: What factors could affect the market share of this biosimilar?
A: Patent disputes, prescriber acceptance, payer formulary decisions, and competitive biosimilar launches.
Q4: What is the main driver for revenue growth in this segment?
A: Increased adoption by healthcare providers and payers, supported by evolving reimbursement policies.
Q5: How do regulatory policies influence biosimilar pricing?
A: Policies enable biosimilar approval and promote competitive pricing but also face patent protections that can delay market entry.
References
[1] IQVIA Institute for Human Data Science. (2022). The Use of Biosimilars in Oncology: Key Trends and Market Outlook.
[2] U.S. Food & Drug Administration (FDA). (2022). Biologics Price Competition and Innovation Act (BPCIA).
[3] EvaluatePharma. (2022). World Preview 2022, Outlook to 2027.
[4] CMS. (2022). Biosimilar Reimbursement Policies.
[5] Market Research Future. (2023). Global Biosimilar Market Analysis.
