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Last Updated: April 15, 2026

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Amjevita (adalimumab-atto) Biosimilar Market Analysis and Price Projections

Last updated: February 18, 2026

Amjevita, the biosimilar to Humira (adalimumab) developed by Amgen, entered the U.S. market in January 2023. This analysis examines its current market position and projects future pricing trends based on competitive landscape, patent expirations, and regulatory factors.

What is Amjevita's Current Market Penetration?

Amjevita is one of the first biosimil adalimumab products approved and launched in the United States. Its market penetration is currently in its early stages, with uptake influenced by payer contracts, physician adoption, and the availability of multiple biosimilar competitors.

As of the first quarter of 2024, Amjevita's market share in the U.S. adalimumab market is estimated to be between 2% and 5%. This figure is subject to rapid change as more biosimil entrants gain traction and payer formulary strategies evolve. The initial launch was limited to certain indications, with broader label expansion anticipated as clinical experience and data accumulate.

Several factors are shaping its current penetration:

  • Payer Exclusivity and Rebates: Major payers have begun to offer Amjevita on their formularies, often with preferred status linked to rebate agreements. These agreements are crucial for incentivizing physicians and patients to switch from the originator product, Humira.
  • Physician Prescribing Habits: While physicians are increasingly open to biosimil adoption, ingrained prescribing habits for Humira remain a barrier. Education and consistent physician outreach are vital for increasing Amjevita's prescription volume.
  • Competitor Landscape: Amjevita faces direct competition from other adalimumab biosimil products, such as Cyltezo (Boehringer Ingelheim) and Hyrimoz (Sandoz), which also launched in 2023. The presence of multiple biosimil options intensifies price competition and impacts individual biosimilar market share.
  • Indication-Specific Uptake: Initial uptake is stronger in specific indications where payers have more aggressive formulary management strategies or where the clinical differentiation between biosimil and originator is perceived as minimal by prescribers.

What is the Competitive Landscape for Adalimumab Biosimilars?

The competitive landscape for adalimumab biosimilars is characterized by multiple U.S. launches in rapid succession, leading to significant price erosion.

Key players in the U.S. adalimumab biosimilar market include:

  • Amgen: Amjevita (adalimumab-atto)
  • Boehringer Ingelheim: Cyltezo (adalimumab-adbm)
  • Sandoz: Hyrimoz (adalimumab-adaz)
  • Organon/Samsung Bioepis: Hadlima (adalimumab-acwa)
  • Mylan (Viatris): Dasetta (adalimumab-aqvk)

These companies launched their biosimil products at different times in 2023 and 2024, following patent litigation resolutions.

U.S. Adalimumab Biosimilar Launch Timeline (Approximate)

Company Biosimilar Name U.S. Launch (Approx.)
Amgen Amjevita January 2023
Boehringer Ingelheim Cyltezo January 2023
Sandoz Hyrimoz January 2023
Organon/Samsung Bioepis Hadlima July 2023
Viatris Dasetta January 2024

The competitive pressure is intense, with biosimilar manufacturers offering substantial discounts compared to the originator Humira. This pricing strategy is essential for gaining market share from a well-established reference product. The number of approved biosimil entrants is expected to grow as additional patent challenges conclude.

What are the Key Patent Expirations and Their Impact?

The patent landscape for adalimumab has been complex, with numerous patents covering various aspects of the drug, including formulation, manufacturing, and method of use. The primary patents that have been litigated and expired or are nearing expiration have enabled biosimilar entry.

  • Composition of Matter Patent: This foundational patent has long expired, allowing for biosimilar development.
  • Manufacturing and Formulation Patents: A series of patents covering manufacturing processes and specific drug formulations have been the subject of extensive litigation. The expiration or successful challenge of these patents has been critical for biosimilar launches.
  • Method of Use Patents: Patents covering the use of adalimumab for specific indications have also played a role. Biosimil manufacturers typically seek approval for a broad label, mirroring the reference product's approved uses.

The resolution of these patent disputes has directly correlated with the timing of biosimilar launches. Companies that successfully navigated patent litigation were able to bring their biosimil products to market, thereby initiating price competition. The continuous resolution of remaining patent challenges will lead to further biosimilar introductions and intensified market dynamics.

What are the Current Pricing Strategies for Amjevita and Competitors?

Biosimilar adalimumab products have adopted aggressive pricing strategies characterized by significant discounts relative to Humira. This approach is designed to incentivize uptake and capture market share.

Estimated Average Wholesale Price (AWP) Discounts (as of early 2024):

  • Amjevita: Offers at least two list prices: one at a 5% discount and another at a 40% discount to Humira's AWP. This dual-pricing strategy aims to capture different market segments and payer preferences.
  • Cyltezo: Launched with a 25% discount to Humira’s AWP.
  • Hyrimoz: Introduced with an initial 45% discount to Humira’s AWP.
  • Hadlima: Launched with a 40% discount to Humira’s AWP.

These list price discounts are indicative of the underlying net price achievable after rebates and contract negotiations. Actual realized prices are considerably lower than the AWP and are highly variable based on payer contracts.

Factors influencing pricing strategies:

  • Rebate Contracts: Biosimilar manufacturers offer substantial rebates to payers and pharmacy benefit managers (PBMs) to secure preferred formulary placement. These rebates can significantly reduce the net cost to payers.
  • Market Share Objectives: The initial pricing is geared towards establishing a foothold. As competition intensifies, further price adjustments are anticipated.
  • Cost of Goods Sold (COGS): The manufacturing costs for biosimil products play a role in setting competitive price points. Amgen has invested in efficient manufacturing processes for Amjevita.
  • Value-Based Agreements: Some payers are exploring value-based contracts that tie reimbursement to patient outcomes, which could influence pricing negotiations.

The initial pricing of Amjevita and its competitors has already led to a significant reduction in the overall spending on adalimumab in the U.S. market.

What are the Projections for Amjevita's Market Share and Price Over the Next Five Years?

Projecting Amjevita's market share and price over the next five years involves assessing several dynamic factors.

Market Share Projections:

  • Year 1-2 (2024-2025): Amjevita's market share is projected to grow from its current low single digits to an estimated 10%-15%. This growth will be driven by increased payer adoption, expanded physician comfort with biosimil switching, and the continued exit of Humira from certain market segments.
  • Year 3-5 (2026-2028): Market share is expected to stabilize and potentially reach 20%-30% of the total U.S. adalimumab market. This projection assumes continued competition, with potential for further biosimilar entrants and ongoing price erosion. The overall adalimumab market size will also be a factor, as newer biologic therapies emerge.

Price Projections:

  • List Price Erosion: The list price for Amjevita and its competitors will likely continue to decline. The initial 5% and 40% discount tiers for Amjevita may see further price reductions, potentially approaching or exceeding 50% discount from Humira's historical list price by 2028.
  • Net Price Compression: Net prices, after rebates, will experience more significant compression. The intense competition among biosimilar manufacturers will force them to offer increasingly aggressive rebate packages to payers. This could lead to net prices that are substantially lower than the initial list price discounts suggest.
  • Therapeutic Area Pricing Divergence: Pricing may diverge based on the specific therapeutic indications. For indications with higher drug spend or where physician switching is more challenging, net prices might remain slightly higher initially, but competitive pressures will likely drive them down over time.
  • Impact of Biosimilar Volume: As the volume of biosimilar adalimumab increases, the perceived value of the originator Humira may decrease, further pressuring prices.

Key Drivers for Projections:

  • Continued Biosimilar Entry: As more adalimumab biosimil patents expire or are successfully litigated, additional competitors will enter the market, intensifying price competition.
  • Payer Strategies: Payers will continue to leverage biosimil competition to achieve significant cost savings. Formulary tiering, prior authorization requirements, and direct rebates will remain key tools.
  • Physician and Patient Acceptance: Increased physician confidence in biosimilar efficacy and safety, coupled with greater patient awareness and willingness to switch, will drive adoption. Real-world evidence from ongoing use will be critical.
  • Manufacturing Scale and Efficiency: Biosimilar manufacturers with optimized production processes will be better positioned to offer lower prices.
  • Regulatory Environment: Favorable regulatory pathways and policies that support biosimilar uptake will positively influence market share and pricing.

Table: Projected Amjevita U.S. Market Share and Price Trends

Metric Early 2024 2025 Projection 2027 Projection
Market Share (U.S. Adalimumab Market) 2%-5% 10%-15% 20%-30%
List Price Discount (vs. Humira AWP) 5% & 40% 40%-60% 50%-70%
Net Price Trend Significant Erosion Continued Compression Further Compression

Note: AWP refers to Average Wholesale Price. Net price reflects actual realized pricing after rebates and discounts.

What are the Regulatory and Policy Factors Influencing Amjevita's Trajectory?

Regulatory and policy frameworks play a critical role in the successful adoption and pricing of biosimil drugs like Amjevita.

Key Influencing Factors:

  • FDA Approval Process: The U.S. Food and Drug Administration's (FDA) rigorous approval process ensures that biosimil products are highly similar to their reference products, with no clinically meaningful differences in safety, purity, and potency. This scientific underpinning is essential for physician and patient confidence.
  • Interchangeability Designation: While Amjevita is approved as a biosimilar, the FDA also has a pathway for "interchangeable" biosimil designation. An interchangeable biosimilar can be substituted for the reference product by a pharmacist without the intervention of the prescribing healthcare provider, mirroring the substitution rules for generic drugs. Amjevita has not yet received an interchangeability designation for all its indications, which can impact its ease of substitution and market penetration compared to interchangeable biosimil.
  • BPCIA (Biologics Price Competition and Innovation Act): This act established the U.S. biosimilar regulatory pathway. Its provisions, including data exclusivity periods for reference biologics and patent litigation frameworks, directly influence biosimilar launch timelines and market entry.
  • Payer and Pharmacy Benefit Manager (PBM) Policies: Payer formulary decisions, rebate negotiations, and incentive programs for physicians and patients significantly shape biosimilar uptake. Policies that encourage biosimilar use, such as preferred tier placement and lower co-pays, are crucial.
  • State Pharmacy Substitution Laws: Laws at the state level governing pharmacist substitution of biosimil for reference biologics can impact the speed and ease of substitution, especially for interchangeable biosimil.
  • Government Pricing Initiatives: Broader healthcare policy discussions and potential government initiatives aimed at reducing drug costs, such as price negotiations or caps, could indirectly affect the pricing landscape for all biologics, including biosimil adalimumab.
  • "Most Favored Nation" Policies: While not directly applied to biosimil pricing, broader policies that seek to align U.S. drug prices with those in other developed countries could create downward pressure on all biologic drug prices over time.

The interplay of these regulatory and policy elements will continue to define the market dynamics for Amjevita and other adalimumab biosimilars.

Key Takeaways

  • Amjevita has initiated its market entry with early penetration estimated at 2%-5%, facing immediate competition from other adalimumab biosimil launches.
  • Aggressive pricing strategies are in place, with Amjevita offering list price discounts of 5% and 40%, while competitors have introduced discounts ranging from 25% to 45%. Net prices are significantly lower due to rebate negotiations.
  • Market share for Amjevita is projected to grow to 10%-15% by 2025 and 20%-30% by 2027-2028, driven by increasing payer adoption and physician comfort.
  • List prices are expected to decline further, with discounts potentially reaching 50%-70% by 2027-2028, and net prices will experience more substantial compression.
  • The regulatory environment, particularly the pathway for interchangeability and evolving payer policies, will significantly influence Amjevita's future trajectory.

Frequently Asked Questions

  1. What is the primary difference between Amjevita and Humira? Amjevita is a biosimilar to Humira. While highly similar in terms of safety, purity, and potency, minor differences in inactive ingredients are permitted. Clinically, they are expected to have the same efficacy and safety profiles.

  2. Can a pharmacist automatically substitute Amjevita for Humira? As of its initial launch, Amjevita is approved as a biosimilar but not necessarily interchangeable across all indications. Interchangeability allows for automatic substitution. The ability to substitute without prescriber intervention depends on the specific FDA designation for Amjevita and state pharmacy laws.

  3. What does "Average Wholesale Price" (AWP) represent in biosimilar pricing? AWP is a reference price used by payers and manufacturers to calculate discounts and rebates. It is not the actual price paid by a patient or payer, which is determined by negotiated net prices after rebates.

  4. How quickly can biosimil competitors erode the market share of the reference product? The speed of market share erosion depends on factors such as the number of biosimilar competitors, their pricing and rebate strategies, payer formulary decisions, and physician adoption rates. For adalimumab, the market has seen rapid initial erosion following multiple biosimilar launches.

  5. Will Amjevita's price continue to fall even after significant initial discounts? Yes, it is highly probable that Amjevita's price will continue to fall. The competitive pressure from multiple biosimil entrants and the strategic imperative for payers to achieve cost savings through aggressive rebate negotiations will drive further price compression.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Biosimilar approvals & designation. Retrieved from [FDA Website URL - placeholder as specific URL not provided] [2] Amgen Inc. (2023). Amjevita® (adalimumab-atto) Prescribing Information. [Product Insert URL - placeholder as specific URL not provided] [3] Boehringer Ingelheim. (2023). Cyltezo® (adalimumab-adbm) Prescribing Information. [Product Insert URL - placeholder as specific URL not provided] [4] Sandoz. (2023). Hyrimoz® (adalimumab-adaz) Prescribing Information. [Product Insert URL - placeholder as specific URL not provided] [5] Organon & Samsung Bioepis. (2023). Hadlima® (adalimumab-acwa) Prescribing Information. [Product Insert URL - placeholder as specific URL not provided]

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