Understanding Humira Biosimilars: A Comprehensive Guide

The pharmaceutical market has been revolutionized with the introduction of biosimilars for the top-selling drug, Humira (adalimumab). After a monopoly of two decades, Humira is now challenged by its first biosimilar, Amjevita, and seven others that were launched in the United States this year. These new players hold the potential to reduce prescription drug prices, yet the exact impact and timing are still uncertain.

This guide will provide an in-depth understanding of adalimumab biosimilars.

The New Contenders in the Market

Eight biosimilars have emerged this year, offering discounts as high as 85% off Humira’s list price of $6922. Some manufacturers even offer dual pricing options.

Here is a brief overview of these biosimilars:

  • Amjevita (adalimumab-atto) by Amgen, launched on January 31 with a discount of 5% to 55%
  • Cyltezo (adalimumab-adbm) from Boehringer Ingelheim, launched on July 1 with a discount of 5% to 7%
  • Hadlima (adalimumab-bwwd) by Organon/ Samsung Bioepis, launched on July 1 with an 85% discount
  • Hulio (adalimumab-fkjp) from Biocon, launched on July 3 with a 5% discount, or 85% for unbranded
  • Hyrimoz (adalimumab-adaz) by Sandoz, launched on July 1 with a 5% discount, or 81% for unbranded
  • Idacio (adalimumab-aacf) by Fresenius Kabi, launched on July 3 with a 5% discount
  • Yuflyma (adalimumab-aaty) from Celltrion, launched on July 2 with a 5% discount
  • Yusimry (adalimumab-aqvh) by Coherus, launched on July 3 with a discount of 84% to 85%

Three of these, namely Hadlima, Hyrimoz, and Yuflyma, are available as high-concentration formulations, which account for 85% of Humira prescriptions, as reported by Goodroot, a group of companies aiming to reduce healthcare expenses.

Interchangeability and Its Implications

Cyltezo holds a unique position as the only adalimumab biosimilar with interchangeability status, allowing pharmacists to replace an equivalent Humira prescription without clinician intervention. This substitution is permissible in 47 states without prior approval from a clinician, but notification is required within a specific period. However, the benefits of this interchangeability for Cyltezo remain unclear, as it corresponds to the lower-concentration version of Humira, which constitutes just 15% of prescriptions.

Most of the companies behind these biosimilars are seeking interchangeability designations for their products, except for Fresenius Kabi (Idacio) and Coherus (Yusimry).

Payer Coverage for Biosimilars

At present, biosimilars are finding their place on formularies alongside Humira, indicating they are considered at the same level. Pharmacy Benefit Management (PBM) companies OptumRx and Express Scripts from Cigna Group have included Amjevita, Cyltezo, and Hyrimoz in their offerings, available at both price points.

According to Isaac Sorensen, a spokesperson for OptumRx, this inclusion provides their clients with the flexibility to access biosimilars at a lower list price. This is particularly beneficial for members on high-deductible plans or those with co-insurance, potentially leading to lower out-of-pocket expenses.

Mark Cuban Cost Plus Drug Company, operating on a direct-to-consumer model, plans to offer Yusimry for $567.27 on its website. SmithRx, a San Francisco-based PBM, intends to collaborate with Cost Plus Drugs to make Yusimry available, allowing SmithRx members to use their insurance benefits for further cost reduction. RxPreferred, another PBM, also plans to offer Yusimry through its partnership with the Cuban company.

Formulary Watch, a news website, reported that CVS Caremark, one of the largest PBMs, will offer Amjevita. However, it will be classified as a non-preferred brand while Humira continues to be the preferred brand. CVS Caremark did not provide a comment to Medscape regarding this matter.

The Impact of Biosimilars on Patient Costs

While biosimilars have been hailed as a potential avenue to reduce expenditure on biologic drugs, it remains uncertain whether patients will see a decrease in their out-of-pocket expenses. Mark Fendrick, MD, Director of the University of Michigan Center for Value-based Insurance Design, has indicated that predicting whether third-party payer discounts will filter down to consumers is challenging.

Typically, a consumer’s co-pay is calculated as a percentage of the drug’s list price. This suggests that a lower drug price could lead to reduced out-of-pocket costs for patients. However, Humira’s copay assistance program, which has successfully reduced prescription costs for consumers, complicates this assumption. A 2022 IQVIA report revealed that, due to this program, 82% of commercial prescriptions for Humira cost patients less than $10.

Fendrick further points out that if biosimilar companies want to be competitive, they will need to offer savings comparable to those of Humira’s program. He warns of potential dissatisfaction if patients are required to pay more out-of-pocket for a less expensive drug.

It should be noted that all eight companies producing these biosimilars either already offer or plan to introduce copay-saving programs. Many of these programs tout copays as low as $0 per month for qualifying patients.

The Future for Humira

With the influx of competition, AbbVie, Humira’s manufacturer, may need to negotiate better deals by increasing rebates on Humira or reducing its price to maintain its market position.

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