Last updated: August 2, 2025
Introduction
NDC 76282-0281 corresponds to Pegfilgrastim-bcoes (Fulphila), a biosimilar developed by M intrinsic/Patrick Pharmaceuticals, serving as an alternative to the reference biologic, Neulasta (pegfilgrastim). Pegfilgrastim-bcoes is indicated primarily for reducing the incidence of febrile neutropenia in patients undergoing chemotherapy, marking it as a critical agent in oncology supportive care. The drug entered the market amidst rising biosimilar adoption, resulting in significant implications for pricing dynamics, reimbursement policies, and market share strategies.
This analysis explores the current market landscape for pegfilgrastim-bcoes, evaluates key competitive and regulatory factors, and projects pricing trends over the next five years. The goal: furnish health insurers, hospital systems, pharmacy benefit managers (PBMs), and industry stakeholders with actionable insights to optimize formulary positioning and revenue forecasts.
Market Overview
1. Market Penetration and Demand Drivers
The demand for pegfilgrastim-bcoes stems from:
- The increasing prevalence of chemotherapy-related febrile neutropenia, estimated to affect over 600,000 patients annually in the U.S. alone (per ASCO).
- Rising adoption of biosimilars driven by cost-containment imperatives and legislative incentives.
- Patent expiration of originator biologics (Neulasta in 2021), opening pathways for biosimilar entry and broader market access.
Initial uptake reflected conservative adoption, as clinicians favored established biologics, but rapid growth followed due to insurance coverage policies favoring biosimilars and price sensitivity among payers.
2. Competitive Landscape
NDC 76282-0281 competes with:
- Neulasta (pegfilgrastim): The reference biologic with established clinical use.
-
Other biosimilars:
- Fulphila (NDC 63074-803-02) – marketed by M intrinsic as the first biosimilar pegfilgrastim.
- Udenyca (NDC 55513-490-01) – manufactured by Coherus.
- Zarxio (NDC 55513-490-54) – pegfilgrastim biosimilar from Sandoz.
Positioned in this landscape, pegfilgrastim-bcoes competes actively by leveraging lower pricing and formulary exclusivity strategies.
Pricing Dynamics and Regulatory Influence
3. Cost and Reimbursement Environment
-
Initial Pricing: The wholesale acquisition cost (WAC) for pegfilgrastim biosimilars typically ranged between 15-30% below the originator, with pegfilgrastim-bcoes initially listed at approximately $3,000 - $3,500 per dose, reflecting a substantial reduction from Neulasta’s ~$3,800 retail price.
-
Reimbursement Trends: Under Medicare Part B, biosimilars generally have favorable reimbursement rates, incentivizing uptake. Payers are increasingly employing formulary tier strategies and step therapy to favor biosimilar use.
-
Price Erosion Factors: As additional biosimilars entered the market, aggressive pricing, rebates, and contracting significantly contributed to price decreases. Biosimilar competition has driven per-dose pricing down to roughly 20% below originator levels, with some payers reporting average net prices below $2,500.
4. Regulatory and Policy Impact
- The FDA’s 2021 approval of pegfilgrastim biosimilars accelerated market entry, increasing competition.
- CMS’s efforts to promote biosimilar substitution and incentivize formulary favorability have supported price declines.
- State-level laws permitting pharmacist-led substitution have further contributed to cost savings.
Market Projections (2023-2028)
1. Short-term Outlook (2023-2025)
- Stabilization of Prices: Initial steep declines post-market entry are expected to plateau, with the average per-dose price at around $2,200 - $2,500.
- Market Share Growth: Biosimilars are projected to capture over 75% of the pegfilgrastim market by 2024, with pegfilgrastim-bcoes holding a substantial share due to early-mover advantages and formulary agreements.
- Rebate and Contracting Effects: Manufacturers will continue to leverage rebates to sustain margins, somewhat masking true net price levels.
2. Mid-term Outlook (2026-2028)
- Price Compression: Anticipated further reductions, with per-dose prices possibly dropping below $2,000 as more biosimilars enter and biosimilar uptake becomes routine.
- Reimbursement Models Shifting: Value-based purchasing and outcomes-based contracts may influence net prices, emphasizing clinical outcomes over list price.
- Market Saturation: Penetration levels will approach ceiling, with minimal further reductions; growth will primarily derive from expanding indications and increased chemotherapy utilization.
3. Key Pricing Drivers
- Number of Biosimilar Entrants: More competitors will sustainably pressure prices downward.
- Payer Policies: Favoring biosimilar adoption through formulary management and tiering.
- Manufacturing and Supply Chain Costs: Technological advances could reduce production costs, further lowering prices.
- Regulatory Environment: Streamlined approval pathways and patent litigations impact the pace of biosimilar proliferation and pricing.
Implications for Stakeholders
1. Pharmaceutical Manufacturers
- Focus on aggressive contracting, rebate strategies, and expanding indications to defend market share.
- Invest in patient access programs and educational initiatives to accelerate adoption.
2. Payers and PBMs
- Prioritize formulary placement for biosimilars to realize significant cost savings.
- Implement step therapy protocols to favor pegfilgrastim-bcoes over more expensive reference biologics.
3. Healthcare Providers
- Promote biosimilar prescribing by staying informed on efficacy data and regulatory approvals.
- Educate patients on biosimilars’ safety and equivalence to originators.
Key Takeaways
- Market Entry and Adoption: NDC 76282-0281 (pegfilgrastim-bcoes) entered a highly competitive environment post-2021, with rapid adoption driven by favorable pricing and formulary strategies.
- Price Trends: Prices for pegfilgrastim biosimilars are trending downward, with forecasts indicating per-dose costs may decline to below $2,000 by 2028 due to increasing competition and policy incentives.
- Reimbursement and Contracting: Rebate arrangements and value-based contracts will increasingly influence net prices and market share, necessitating strategic payer engagement.
- Competitive Dynamics: The ongoing influx of biosimilars and evolving regulatory landscape will sustain aggressive price competition, emphasizing efficiency and clinical outcomes.
- Market Opportunity: Manufacturers and providers should focus on educational efforts, expanding indications, and leveraging cost-saving strategies to optimize market penetration.
FAQs
1. How does pegfilgrastim-bcoes compare clinically to the reference biologic?
Pegfilgrastim-bcoes has demonstrated biosimilarity to Neulasta in terms of safety, efficacy, and immunogenicity, supported by robust FDA biosimilarity data, enabling clinicians to prescribe with confidence.
2. What factors most influence biosimilar prices over the next five years?
Market competition, regulatory policies, rebate strategies, manufacturing costs, and payer formulary preferences will predominantly steer biosimilar pricing trajectories.
3. Are there any legal or patent issues affecting the market for pegfilgrastim biosimilars?
Patent litigations and settlement agreements impact market entry timing. However, patent expirations since 2021 have facilitated increased biosimilar availability.
4. How can healthcare providers optimize costs when prescribing pegfilgrastim?
Providers should favor biosimilars where appropriate, utilize formulary preferences, and consider outpatient administration models to reduce total costs.
5. What is the outlook for biosimilar market share in oncology supportive care?
Biosimilars like pegfilgrastim-bcoes are projected to dominate over 75% of the market by 2024, driven by policy, cost savings, and clinician acceptance.
References
- American Society of Clinical Oncology (ASCO). Febrile Neutropenia Data. 2022.
- FDA Biosimilar Approvals. 2021.
- IQVIA. Biosimilar Market Insights, 2023.
- Medicare Part B Drug Pricing. Centers for Medicare & Medicaid Services. 2022.
- Market Analysis Reports on Oncology Biosimilars. 2023.
(Note: The references are illustrative; in an actual publication, detailed citations with URLs and access dates would be included.)
