Last updated: February 24, 2026
What is NDC 62559-0291?
NDC 62559-0291 corresponds to a biosimilar version of a biologic drug. Based on data from the FDA and commercial databases, this NDC refers to Amjevita (adalimumab-atto), a biosimilar to Humira (adalimumab). It was approved by the FDA on September 24, 2018, and launched in the U.S. market during 2020.
Market Landscape
Product Profile
- Active Ingredient: Adalimumab, a monoclonal antibody targeting TNF-alpha.
- Indications: Rheumatoid arthritis, psoriasis, Crohn's disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis.
- Formulation: Prefilled syringe or auto-injector.
Market Size
The biologics market for adalimumab was valued at approximately $20 billion in 2022 in the U.S., with Humira accounting for nearly 60% of that market. Biosimilars, including Amjevita, have captured a fraction of this due to patent expirations.
Patent Timeline
Humira's U.S. patents expired in 2023. Prior to that, biosimilar entry was delayed by patent litigation and exclusivity agreements.
Competitive Landscape
| Product |
Approval Date |
Market Share (2022) |
Price (per dose) |
Manufacturer |
| Humira (reference) |
December 2002 |
60% of total market |
$5,000 |
AbbVie |
| Amjevita |
September 2018 |
~2% of adalimumab market |
$3,600 (initial) |
Amgen |
| Other biosimilars |
2023 onward |
Rising |
$2,600–$3,000 |
Multiple manufacturers |
Adoption Factors
- Biosimilar uptake is influenced by formulary preferences, prescriber familiarity, and insurance policies.
- Patent expiry in 2023 has triggered entry of multiple biosimilars, increasing price competition.
Price Projections
Past Pricing Trends
- Humira: Stable pricing around $5,000 per dose pre-2023.
- Amjevita (NDC 62559-0291): Initial launch price at approximately $3,600 per dose, about 30% lower than Humira.
- Post-2023 market entry saw a price decrease as biosimilars gained market share.
Short-Term Forecast (2023–2025)
| Year |
Estimated Average Price per Dose |
Market Share |
Notes |
| 2023 |
$3,200 |
10% |
Price declines driven by biosimilar competition |
| 2024 |
$2,800 |
25% |
Further adoption, price adjustments |
| 2025 |
$2,600 |
35% |
Market stabilization |
Assumptions:
- Incremental biosimilar adoption accelerates due to patent launches.
- Insurance discounts and PBM negotiations further pressure prices downward.
- No significant new indications or regulatory hurdles emerge.
Long-Term Projections (2026–2030)
| Year |
Estimated Price per Dose |
Market Share |
Factors Influencing Price |
| 2026 |
$2,400 |
50% |
Increased biosimilar market penetration |
| 2028 |
$2,200 |
65% |
Patent expiry discounts fully realized |
| 2030 |
$2,000 |
75% |
Dominance of biosimilars, generic competition |
Factors Impacting Price Trajectory
- Patent Litigation: Resolutions and patent challenges could accelerate biosimilar entry.
- Regulatory Policies: Policies promoting biosimilars (e.g., interchangeability) will influence price competition.
- Market Penetration: Payer preferences and formulary wins impact adoption.
- Manufacturing Costs: Biosimilar manufacturing efficiencies could lead to further price reductions.
Summary of Key Factors
- Market share expansion for biosimilars has driven significant price reductions since 2023.
- Prices are projected to decline steadily over the next decade, approaching approximately $2,000 per dose by 2030.
- Adoption rates depend on regulatory developments, patent litigation, and payer policies.
Key Takeaways
- NDC 62559-0291, Amjevita, remains a key player among adalimumab biosimilars, with near-term prices around $2,800.
- Biosimilars are expected to gain substantial market share, reducing prices further.
- Long-term price projections see average doses falling to around $2,000 by 2030.
- Market dynamics depend heavily on patent outcomes, regulatory policies, and payer acceptance.
- Competitive pressure from new biosimilars accelerates price erosion, possibly affecting revenue streams for originators.
FAQs
1. How soon could prices for NDC 62559-0291 decline further?
Prices are projected to decline gradually through 2025 as biosimilar adoption increases, reaching approximately $2,600 per dose.
2. What factors could disrupt the current price projections?
Regulatory changes, patent disputes, supply chain issues, or slower-than-expected biosimilar adoption could alter price trends.
3. How does the entry of multiple biosimilars impact overall market prices?
Multiple biosimilars increase competition, leading to further price reductions and market share redistribution.
4. Will Amjevita maintain its market position beyond 2025?
Its market share will depend on formulary acceptance, clinician preferences, and pricing strategies from competitors.
5. Are there opportunities for new biosimilar entrants?
Yes, patent expirations in 2023 open the door for additional biosimilar entrants, which can further intensify price competition.
References
[1] Food and Drug Administration (FDA). (2018). Approval of Amjevita.
[2] IQVIA. (2022). U.S. Biologics Market Data.
[3] EvaluatePharma. (2023). Biologics Market and Price Trends.
[4] Generic Pharmaceutical Association. (2023). Biosimilar Market Entry and Competition Reports.
