Last updated: February 19, 2026
What is NDC 82089-0103?
NDC 82089-0103 is a drug marketed by Coherus Biosciences, which is identified as a biosimilar. It corresponds to the biosimilar version of Amgen’s Neulasta (pegfilgrastim). The drug is used to reduce the incidence of neutropenia and infection in patients undergoing chemotherapy.
Market Overview
Product Status
- Type: Biosimilar (pegfilgrastim)
- Market Launch: Expected in the U.S. following FDA approval.
- FDA Approval Date: Pending or recent, as of publication.
Market Environment
- Prior Monopolist: Amgen’s Neulasta domineers the market with an estimated 93% share in 2022.
- Market Size: The global pegfilgrastim market valued at approximately $3 billion in 2022.
- Key Competitors: Neulasta (Amgen), Fulphila (Mylan/Biocon), Ziextenzo (Sandoz), and others.
- Pricing Landscape: Biosimilars are typically priced 15-30% below the reference product.
Patient Pool
- 250,000 to 300,000 patients receive pegfilgrastim annually in the U.S.
- Insurers and payers push for biosimilar adoption to reduce costs.
Pricing Projections
Current Pricing Dynamics
- Reference Product (Neulasta): Approximate wholesale acquisition cost (WAC) per dose: $4,500.
- Biosimilar Price Range: 15-25% discount on Neulasta, i.e., $3,375 to $3,825 per dose.
Projected Biosimilar Pricing
- Initial Launch Price: Likely 15% below Neulasta, around $3,825.
- One Year Post-Launch: Price stabilization at 20% below Neulasta, around $3,600.
- Long-term Equilibrium: 25-30% below Neulasta, around $3,200, factoring in payer discounts and market penetration.
Volume and Revenue Estimates
- Market Penetration: 30-50% within three years, assuming favorable formulary positioning.
- Annual Revenue Projection: With a 40% market share and $3,600 per dose, potential revenues target $540 million annually (assuming 150,000 treated patients).
Factors Influencing Price
- Manufacturing Costs: Biosimilar production costs are approximately 50% lower than innovator — roughly $1,200–1,500 per dose.
- Reimbursement Policies: Evolving payer policies could impact net pricing.
- Market Competition: Entry of additional biosimilars may drive price further down.
Regulatory and Policy Impact
- The FDA's biosimilar pathway since 2015 has accelerated approvals.
- CMS and private payers increasingly favor biosimilars to lower overall healthcare expenditure.
- State laws may restrict substitution without prescriber approval.
Risks and Opportunities
Risks
- Delays in approval or limited market acceptance.
- Patent litigation delaying market entry.
- Price erosion due to new biosimilars or generics.
Opportunities
- Early market entry can secure share.
- Price negotiations with payers can increase margins.
- Potential for innovative labeling or administration routes to differentiate offerings.
Key Takeaways
- NDC 82089-0103 is a biosimilar of Neulasta targeting a substantial oncology market segment.
- Initial prices are expected 15-25% lower than Neulasta, with further decreases over time.
- Revenue estimates near $540 million annually in the first three years with strong market penetration.
- Market variables include regulatory approval timing, payer policies, and competition.
FAQs
1. When is NDC 82089-0103 expected to launch?
The exact launch date depends on FDA approval and market readiness; recent updates suggest approval could occur within 12-24 months.
2. How does biosimilar pricing compare to the reference product?
Initially 15-25% lower, with long-term discounts potentially reaching 30%.
3. Who are the main competitors for this biosimilar?
Amgen’s Neulasta remains dominant; other biosimilars like Fulphila, Ziextenzo, and Long-Acting G-CSF competitors are relevant.
4. What factors could impact future price reductions?
Introduction of additional biosimilars, payer negotiation leverage, and market demand.
5. What is the potential market size for this biosimilar?
Approximately $300 million to $600 million annually, assuming significant adoption in the U.S. oncology market.
References
[1] MarketResearch.com. (2022). Global pegfilgrastim market analysis.
[2] U.S. FDA. (2023). Biosimilar products approval data.
[3] IQVIA. (2022). Oncology supportive care market report.
[4] CMS.gov. (2022). Policy updates on biosimilar substitution.
[5] EvaluatePharma. (2022). Biologic and biosimilar market forecasts.
Note: All data projections are estimates based on current market conditions as of early 2023 and may vary with future regulatory and market developments.
