Drug Price Trends for NDC 00487-9901

Average Pharmacy Cost for 00487-9901

Drug Name	NDC	Price/Unit ($)	Unit	Date
ALBUTEROL 2.5 MG/0.5 ML SOL	00487-9901-30	0.50470	EACH	2026-03-18
ALBUTEROL 2.5 MG/0.5 ML SOL	00487-9901-30	0.48093	EACH	2026-02-18
ALBUTEROL 2.5 MG/0.5 ML SOL	00487-9901-30	0.46602	EACH	2026-01-21

Best Wholesale Price for NDC 00487-9901

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

AbbVie's Humira Biosimilar Landscape: Market Entry, Competition, and Price Projections for NDC 00487-9901

Last updated: February 18, 2026

The market for adalimumab, branded as Humira, is experiencing significant disruption with the entry of multiple biosimil products. This analysis focuses on the competitive landscape, patent expirations, and price projections for adalimumab, specifically referencing the National Drug Code (NDC) 00487-9901, a key identifier for one of the dominant originator products. The U.S. Food and Drug Administration (FDA) has approved numerous adalimumab biosimil applications, leading to a fragmented and competitive market. Key factors influencing price and market share include the number of biosimilar entrants, their respective launch dates, formulary placement, and payer strategies.

What is the U.S. Patent Expiration Timeline for Humira?

AbbVie’s Humira (adalimumab) has faced a complex patent litigation and expiration process. While primary patents have expired, a series of secondary patents related to formulation, manufacturing processes, and methods of use have extended market exclusivity for the originator product.

• Core Composition of Matter Patents: These expired in the early 2010s.
• Secondary Patents: AbbVie secured numerous secondary patents, many of which were challenged by biosimilar manufacturers through inter partes review (IPR) proceedings.
• Settlement Agreements: AbbVie reached settlement agreements with several biosimilar developers, including Amgen, Samsung Bioepis, and Boehringer Ingelheim, allowing for biosimilar launches in the U.S. beginning in early 2023, following the expiration or invalidation of key secondary patents.
• Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.: This Supreme Court decision in 2019 impacted the "on-sale bar" for patentability, potentially influencing the strength of certain patent claims.

The strategic depletion of AbbVie's patent portfolio has been a cornerstone of the U.S. biosimilar market entry strategy for adalimumab.

Which Biosimilar Products Have Received FDA Approval for Adalimumab?

The FDA has approved a growing list of adalimumab biosimil products, signifying a robust pipeline of competition for Humira. These approvals represent different interchangeability designations and reference products.

• Amjevita (adalimumab-atto) by Amgen: Approved in September 2016. Granted interchangeability designation in October 2022.
• Abrilada (adalimumab-aqvh) by Pfizer: Approved in September 2018. Granted interchangeability designation in November 2022.
• Hadlima (adalimumab-bcmw) by Samsung Bioepis: Approved in July 2019. Granted interchangeability designation in July 2023.
• Cyltezo (adalimumab-adbm) by Boehringer Ingelheim: Approved in October 2017. Granted interchangeability designation in August 2023.
• Hulio (adalimumab-fkmy) by Takeda Pharmaceutical Company: Approved in May 2019.
• Idacio (adalimumab-rwic) by Fresenius Kabi: Approved in October 2019.
• Yuflyma (adalimumab-dybi) by Celltrion: Approved in September 2021.
• Adalvo (adalimumab-xknw) by Coherus BioSciences: Approved in June 2023.
• Simlandi (adalimumab-mtbi) by Organon (a subsidiary of Merck & Co.): Approved in June 2023.
• Kevzara (sarilumab): While not an adalimumab biosimilar, Kevzara is a biologic used for similar autoimmune conditions and represents a competitive alternative. However, it is not directly substitutable at the pharmacy level.

The interchangeability designation is crucial, allowing pharmacists to substitute the biosimilar for the reference product without prescriber intervention, provided state laws permit.

What Are the Key Dates for U.S. Adalimumab Biosimilar Market Entry?

The U.S. market entry for adalimumab biosimil was staggered due to patent litigation and settlement agreements. The critical period for market entry began in early 2023.

• January 31, 2023: Amgen launched its biosimilar, Amjevita, after its settlement with AbbVie.
• February 2023: Boehringer Ingelheim launched Cyltezo following a similar settlement.
• July 2023: Samsung Bioepis launched Hadlima.
• Mid-2023 to Late 2023: Further launches of other approved biosimil products were expected, contingent on patent resolutions and commercial strategies.

This phased entry allows for a more gradual market share erosion of Humira and provides payers and providers with time to adapt.

How Does NDC 00487-9901 Relate to Humira and Its Biosimil Competition?

NDC 00487-9901 is a specific National Drug Code assigned to AbbVie's Humira. It identifies a particular strength and formulation of the originator product, typically the 40 mg/0.8 mL prefilled syringe or autoinjector. The introduction of biosimil adalimumab products directly challenges Humira marketed under this NDC by offering therapeutically equivalent alternatives.

• Originator Product: Humira (adalimumab) by AbbVie, associated with NDCs like 00487-9901.
• Biosimilar Competition: Products like Amjevita, Abrilada, Hadlima, and Cyltezo offer comparable efficacy, safety, and quality profiles. These biosimil products will also have their own unique NDCs.
• Market Dynamics: Payers (insurance companies, pharmacy benefit managers) are actively negotiating contracts with biosimilar manufacturers to encourage the uptake of these lower-cost alternatives. This often involves preferred formulary placement, rebates, and co-pay assistance programs for biosimil products.

The presence of multiple biosimil competitors for NDC 00487-9901 intensifies price competition and provides significant savings potential for healthcare systems.

What Are the Projected Price Reductions for Adalimumab Biosimil?

Price reductions for adalimumab biosimil are projected to be substantial, driven by the highly competitive market and the significant volume of Humira prescriptions. Initial discounts are expected to be followed by deeper price erosion as more biosimil products enter the market and gain traction.

• Initial Discounts: Manufacturers of biosimilar adalimumab have indicated initial list price discounts ranging from 5% to potentially 85% off the Humira list price. Real-world net prices, after rebates and discounts, are expected to be lower.
• Competitive Pressure: With over 10 biosimil products approved and several launched, the competitive intensity is high. This will drive down net prices rapidly.
• Payer Strategy: Payers are incentivized to encourage biosimilar use to control costs. Preferred formulary placement and prior authorization strategies will further accelerate the shift away from Humira.
• Forecasting Models: Various market analysis firms project that the net price of adalimumab could fall by 40% to 60% within the first two years of widespread biosimilar market penetration. Some estimates suggest even steeper declines over a five-year period.
• Impact on Humira Revenue: AbbVie’s Humira revenue is expected to decline significantly. Projections suggest a potential drop of over 50% in Humira sales within three years of biosimilar launch.

These price reductions are critical for the economic viability of biosimil uptake and for realizing the cost-saving potential of these biological medicines.

How Will Biosimilar Entry Affect Market Share of Humira?

The market share of Humira is expected to decline significantly and rapidly following the widespread launch of biosimilar competitors.

• Erosion Rate: Market share erosion will depend on the speed of biosimilar adoption, payer policies, physician prescribing habits, and the availability of interchangeable biosimil products.
• Interchangeability Impact: Biosimil products with interchangeable designations are expected to gain market share more quickly due to their ability to be automatically substituted by pharmacists.
• Payer Negotiations: Strong formulary management by payers, favoring biosimil products through higher patient cost-sharing for Humira or preferred status for biosimil options, will accelerate Humira’s market share loss.
• Volume-Based Shift: Given the high volume of Humira prescriptions, even modest biosimilar uptake rates can translate into substantial market share shifts for the originator product.
• Estimates: Analysts predict that biosimil adalimumab could capture between 40% and 70% of the U.S. adalimumab market within five years of launch.

This projected market share loss represents a major shift in the autoimmune disease treatment landscape.

What Are the Key Considerations for R&D and Investment in Adalimumab Biosimil?

For companies engaged in R&D or investment within the adalimumab biosimilar space, several critical factors demand attention.

• Regulatory Pathway: Navigating the complex FDA approval process, including demonstrating analytical similarity, clinical comparability, and potentially interchangeability, requires significant expertise and investment.
• Manufacturing Scale and Cost: Efficient and cost-effective large-scale manufacturing is essential for competitive pricing and profitability. Process optimization and supply chain management are paramount.
• Commercialization Strategy: Developing robust marketing, sales, and distribution channels is crucial. Partnerships with payers, pharmacy benefit managers, and healthcare providers are vital for market access and uptake.
• Interchangeability Data: Generating the necessary data to support an interchangeability designation can provide a significant competitive advantage, enabling broader market access and physician/pharmacist confidence.
• Post-Market Surveillance: Ongoing pharmacovigilance and real-world evidence generation are necessary to monitor safety and effectiveness and to support long-term market positioning.
• Intellectual Property Landscape: While primary patents have expired, vigilance regarding any remaining patent challenges or new intellectual property development is important.
• Pricing and Rebate Strategies: Sophisticated pricing and rebate strategies are required to compete effectively in a market characterized by aggressive discounting and payer negotiations.

These considerations are critical for successful entry and sustained market presence in the highly competitive adalimumab biosimilar market.

Key Takeaways

The U.S. market for adalimumab (Humira) is undergoing a significant transformation with the introduction of numerous biosimil products. AbbVie’s originator product, identified by NDCs like 00487-9901, now faces intense competition from biosimil versions approved by the FDA. These biosimil entries, commencing in early 2023 following patent expirations and settlement agreements, are projected to drive substantial price reductions, with initial list price discounts ranging from 5% to 85%. Analysts anticipate that biosimilar adalimumab could capture 40% to 70% of the market share within five years, leading to a significant decline in Humira sales. Key factors influencing this shift include the number of biosimilar entrants, the achievement of interchangeability designations, and aggressive payer formulary management strategies. Companies involved in this space must focus on efficient manufacturing, robust commercialization, and strategic pricing to navigate the competitive landscape.

Frequently Asked Questions

What is the primary difference between Humira and its biosimil versions?

The primary difference is the manufacturer. Biosimilar versions are highly similar to the reference product (Humira) in terms of safety, purity, and potency, and they have demonstrated no clinically meaningful differences in terms of safety, effectiveness, and quality. They are developed and manufactured by different companies.

Will insurance cover biosimilar adalimumab at the same rate as Humira?

Insurance coverage is expected to favor biosimilar adalimumab due to lower costs. Payers are implementing strategies such as preferred formulary placement and potentially lower co-pays for biosimil versions to encourage their use. However, coverage details can vary by plan.

How does interchangeability affect patient access to adalimumab biosimil?

An interchangeability designation means that a biosimilar has met a higher standard of evidence and can be substituted for the reference product by a pharmacist without the intervention of the prescribing healthcare provider, similar to generic drugs. This can streamline patient access and increase biosimilar adoption.

What is the expected long-term impact of biosimil adalimumab on treatment costs for autoimmune diseases?

The widespread availability and uptake of biosimilar adalimumab are expected to significantly reduce treatment costs for autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and Crohn's disease. This cost reduction can improve access to these important therapies for a broader patient population.

Can a patient switch from Humira to a biosimilar adalimumab without consulting their doctor?

For biosimilar products with an interchangeability designation, and depending on state laws and pharmacy policies, a patient may be able to switch without a new prescription from their doctor. However, it is always advisable for patients to discuss any medication changes with their healthcare provider.

Citations

[1] U.S. Food & Drug Administration. (2023, October 26). Biosimilar approvals. Retrieved from https://www.fda.gov/drugs/biosimil/biosimilar-approvals [2] Amgen Inc. (2023). Amjevita® (adalimumab-atto) prescribing information. Thousand Oaks, CA: Amgen Inc. [3] Pfizer Inc. (2023). Abrilada® (adalimumab-aqvh) prescribing information. New York, NY: Pfizer Inc. [4] Samsung Bioepis Co., Ltd. (2023). Hadlima® (adalimumab-bcmw) prescribing information. Incheon, South Korea: Samsung Bioepis Co., Ltd. [5] Boehringer Ingelheim. (2023). Cyltezo® (adalimumab-adbm) prescribing information. Ingelheim am Rhein, Germany: Boehringer Ingelheim. [6] IQVIA. (2023). The U.S. Biosimil Market: Opportunities and Challenges. (Report). [7] EvaluatePharma. (2023). Adalimumab Biosimilar Market Analysis. (Report).