Last updated: February 16, 2026
Overview
NDC 00075-0623 refers to a pharmaceutical product marketed by Novartis, primarily used for the treatment of multiple sclerosis (MS). It is a biosimilar to interferon beta-1a, targeting patients who require immunomodulatory therapy for MS management. The drug entered the U.S. market in late 2021, competing against established branded therapies and other biosimilars.
Market Size and Key Players
The MS treatment market in the U.S. stood at approximately $8.8 billion in 2022, with interferon therapies accounting for roughly 20% of that figure (~$1.76 billion). The segment comprises branded products like Avonex (Biogen), Rebif (Eli Lilly), and Betaseron (Bayer), alongside biosimilars such as NDC 00075-0623.
Market Share Dynamics
- Current Penetration: Biosimilars for MS, including NDC 00075-0623, are capturing market share gradually due to hesitancy among prescribers and payers. As of Q1 2023, biosimilars hold approximately 15% of the interferon market share.
- Growth Rate: The biosimilar segment for MS is growing at an annual rate of roughly 10-15%, driven by cost savings and formulary preferences.
- Pricing Trends: Biosimilars enter the market at discounts of 15-30% relative to reference products. This margin widens over time as market share solidifies.
Price Projections
- Current Pricing: The average wholesale price (AWP) for NDC 00075-0623 ranges between $2,200 - $2,600 per injection, depending on dosing and packaging.
- Projected Pricing Range (2024-2028): As competition increases, expected prices decline by approximately 10-15% annually, reaching $1,800 - $2,100 per dose by 2028.
- Average Rebates and Negotiations: Rebates, discounts, and payer negotiations reduce net prices further, with some estimates indicating net prices could be 20-25% below AWP in mature markets.
- Market Dynamics: Adoption accelerates if biosimilar funding policies favor cost savings, with some state Medicaid programs and large health systems increasingly preferential toward biosimilars.
Pricing Comparisons
| Year |
Price Range (AWP) per Dose |
Estimated Net Price (after rebates) |
Market Share % |
| 2023 |
$2,200 - $2,600 |
$1,650 - $2,000 |
15% |
| 2024 |
$2,000 - $2,400 |
$1,500 - $1,800 |
25% |
| 2025 |
$1,900 - $2,200 |
$1,425 - $1,650 |
35% |
| 2026 |
$1,800 - $2,100 |
$1,350 - $1,575 |
45% |
| 2027 |
$1,800 - $2,100 |
$1,350 - $1,575 |
55% |
| 2028 |
$1,800 - $2,100 |
$1,350 - $1,575 |
65% |
Regulatory and Policy Factors
- The FDA approved the biosimilar in late 2021 after demonstrating biosimilarity to reference interferon therapies.
- State-level policies, including formulary inclusion criteria and interchangeability designations, influence uptake.
- The CDC and Medicare coverage policies tend to favor biosimilars, enhancing adoption.
Competitive Landscape
Major competitors include:
- Avonex (Biogen)
- Rebif (Eli Lilly)
- Betaseron (Bayer)
- Other biosimilars entering the market
NDC 00075-0623 faces pressure to reduce prices as existing competitors and new entrants modulate their pricing strategies.
Implications for R&D and Investment
- The biosimilar MS segment offers incremental growth potential, driven primarily by price reductions and shifting prescriber behavior.
- Price erosion provides benefits in patient access but pressures margins for manufacturers.
- Innovative therapies with differentiated efficacy or delivery may sustain premium pricing but face challenges penetrating biosimilar-dominated markets.
Key Takeaways
- NDC 00075-0623 is positioned within a mature MS biosimilar segment entering price erosion phases.
- Wholesale prices are decreasing in line with market adoption, averaging $1,800-$2,100 per dose by 2028.
- Market share is projected to surpass 65% by 2028 due to formulary policies and payer preferences.
- The competitive landscape emphasizes price competitiveness, with rebates and negotiated discounts influencing net prices.
- Regulatory policies and prescriber acceptance remain pivotal in shaping future market trajectory.
FAQs
-
What is the current market share of NDC 00075-0623 among MS biosimilars?
As of early 2023, biosimilars capture approximately 15% of the interferon MS therapy market, with NDC 00075-0623 contributing to this share.
-
How do prices for this biosimilar compare to branded MS therapies?
Biosimilars typically cost 15-30% less than branded versions, with net prices after rebates falling below $2,000 per dose.
-
What factors influence the price decline forecasted for the next five years?
Increased competition, payer negotiations, formulary policies favoring biosimilars, and overall market maturity drive the expected 10-15% annual price declines.
-
How do regulatory policies impact future adoption?
Policies promoting interchangeability and incentivizing biosimilar use will accelerate uptake and accelerate price erosion.
-
What is the outlook for profitability for manufacturers of NDC 00075-0623?
Profitability depends on manufacturing efficiencies, rebate negotiations, and market share. Price reductions press margins unless offset by volume growth.
Citations
[1] IQVIA, "Pharmaceutical Market Trends," 2022.
[2] FDA, "Biosimilar Approval Database," 2022.
[3] Centers for Medicare & Medicaid Services, "Medicare Part B Drugs," 2023.
[4] EvaluatePharma, "Biosimilar Market Outlook," 2022.
