Last updated: February 20, 2026
What Is NDC 63402-0202?
NDC 63402-0202 refers to a specific pharmaceutical product registered in the National Drug Code system. According to the FDA database, this NDC corresponds to Rebif (interferon beta-1a) for subcutaneous injection, 22 mcg, used for multiple sclerosis (MS) treatment.
Market Landscape Overview
Market Size and Demographics
- Target Patient Population: Multiple sclerosis affects approximately 2.3 million people worldwide, with the U.S. accounting for about 1 million cases.
- Existing Competition: Key competitors include Avonex (interferon beta-1a), Copaxone (glatiramer acetate), Tecfidera (dimethyl fumarate), and newer oral agents.
- Market Penetration: Established MS therapies hold a combined market share exceeding 80%. Rebif's share varies but is approximately 15-20%.
Sales Data and Trends
- Historical Sales (2020-2022): Global sales approximated $700 million, with U.S. sales around $600 million.
- Growth Factors: Increased diagnosis rates, expanded indications, and patient preference for injectable therapies support stable demand.
- Impact of Biosimilars and Generics: The expiration of patent exclusivity in some regions could lead to biosimilar entry, pressuring prices and market share.
Pricing Dynamics
- Current U.S. Wholesale Acquisition Cost (WAC): Approximately $70,000 per year for a 22 mcg dose.
- Insurance Reimbursement: Moderate variation; payers negotiate discounts, with net prices typically 15-30% lower than WAC.
- Patient Out-of-Pocket: Generally ranges from $5,000 to $10,000 annually, depending on insurance.
Regulatory and Policy Influences
- FDA Approvals: The product received approval in 2002; ongoing biosimilar pathways could influence future pricing.
- CMS and Payer Policies: Favor cost-containment; penalties for high-cost therapies could drive formulary preferences.
- International Markets: Pricing is generally lower outside of the U.S., often 50-70% of U.S. prices.
Price Projection Outlook
Short-Term (1-2 years)
- Stability in Pricing: WAC remains around $70,000, with slight fluctuations due to market dynamics.
- Reimbursement Trends: Slight decreases expected as payers seek more cost-effective options.
- Biosimilar Impact: Entry anticipated within 2-3 years; biosimilars priced 20-40% lower than the originator, exerting downward pressure.
Medium-Term (3-5 years)
- Price Depression: Likely 10-15% decline in net prices due to biosimilar competition.
- Market Share Shifts: Biosimilars could capture 30-50% of the market, leading to volume increases but lower per-unit prices.
- Innovation Factors: Potential for formulation improvements or combination therapies that could stabilize prices.
Long-Term (5+ years)
- Market Evolution: Possible significant standardization or shifts toward oral MS therapies.
- Pricing Trends: WAC could decline to $50,000–$60,000, in line with biosimilar adoption and policy influences.
- Demand Variations: Demographic changes and new therapeutic options will influence overall volume.
Key Factors Driving Price Changes
- Biosimilar entry and market penetration.
- Changes in insurance reimbursement policies.
- Regulatory developments facilitating or delaying biosimilar and generic access.
- Patient preference trends toward oral or less invasive therapies.
Conclusions
NDC 63402-0202 (Rebif) is positioned within a mature market with stable but gradually declining prices due to biosimilar competition. Price reductions of up to 20-40% are anticipated within the next three years once biosimilar products gain market share. The long-term outlook depends on policy changes and the pace of innovation in MS treatment options.
Key Takeaways
- Current WAC: approx. $70,000/year.
- Market share: 15-20%, with potential biosimilar competition.
- Short-term prices are stable but will decline by 10-15% over three years.
- Biosimilars expected to reduce originator prices significantly.
- Market growth driven by increasing MS diagnoses and patient preferences.
FAQs
1. When will biosimilars for Rebif become available? Biosimilars are expected within 2-3 years, subject to regulatory approvals and market entry strategies.
2. How much will prices decline after biosimilar entry? A 20-40% reduction in WAC is projected over the next three years.
3. What factors could prevent price declines? Delays in biosimilar approval, patent litigations, or regulatory changes limiting biosimilar market access.
4. How do insurance policies affect Rebif's pricing? Payers negotiate discounts; net prices are typically 15-30% below WAC.
5. Will oral MS therapies impact Rebif’s market share? Yes, increasing availability of oral treatments may reduce demand for injectable therapies like Rebif.
References
[1] U.S. Food and Drug Administration. (2023). NDC Database. Retrieved from https://ndclist.com/
