Between the launch of 7 adalimumab biosimilars, the release of several market trend reports, and clinical trial results on often ignored disease states, July was a very big month for immunology biosimilars.
Between the launch of 7 adalimumab biosimilars, the release of several market trend reports, and clinical trial results on often ignored disease states, July was a very big month for immunology biosimilars.
US Launches of Adalimumab Biosimilars
The first launch in July included 4 adalimumab biosimilar products: Cyltezo, Yusimry, Hadlima, and Hyrimoz.
Cyltezo is the only adalimumab biosimilar to have interchangeability. Yusimry is the only biosimilar to have a deal with the Mark Cuban Cost Plus Drug Company, an online pharmacy offering generic drugs at steep discounts to their originators. Hadlima and Hyrimoz each launched with a low-concentration formulation and a high-concentration formulation.
Celltrion’s Yuflyma was the next adalimumab product to launch. The product is only available as a citrate-free, high-concentration formulation and has a wholesale acquisition cost of $3288.25 per single-use unit to administer.
The last 2 products to launch in July were Idacio and Hulio, both of which are only available as low-concentration formulations. Idacio is Fresenius Kabi’s first immunology biosimilar and is the second biosimilar from the company to launch in 2023, following Stimufend (pegfilgrastim biosimilar). Hulio was originally developed by Viatris; however, Viatris sold its entire biosimilar portfolio to Biocon Biologics and is assisting the new owner with the transition.
Market Insights and Pricing Changes
A review article offered new perspective on the growing adalimumab market and whether these new products will lead to lower costs for patients. The article highlighted the variations between products, including the citrate-concentrations, high vs low concentration, and administration device variances, as concerns.
Additionally, dual-pricing strategies to get products on formulary lists create confusion and could lead to patients experiencing higher out-of-pocket costs. The authors made several policy recommendations to ensure lower patient costs and fair market competition.
A contributor article crafted by 4 pharmacists offered advice to clinics on how they can prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges. The article stressed the importance of health systems equipping their teams with education materials, becoming familiar with the variances between products, and monitoring state laws.
One study evaluating the launch price associated with Amgevita, the first adalimumab biosimilar to launch in the United States, compared with the originator (Humira) found that the list prices of the biosimilar were more than double the original price of Humira.
This was in part because AbbVie, the manufacturer of Humira, has dramatically raised the price of Humira over time to maximize profits before facing market competition. This price difference between the launch prices of adalimumab biosimilars and the originator can also be seen with Yuflyma, branded Hyrimoz, Cyltezo, branded Hulio, and Idacio.
However, a study of price changes in Europe found that prices of tumor necrosis factor-α inhibitors, such as infliximab, adalimumab, and etanercept, resulted in significant price reductions after the first and second biosimilars entered the market.
Clinical Trial Results
Often, immunology biosimilars are approved by the FDA using data that evaluate that drug in patients with rheumatoid arthritis. However, a recent study assessing an infliximab biosimilar found that the product has a similar safety and efficacy profile to the originator (Remicade) in patients with inflammatory bowel disease.
Additionally, a study from India showed that an adalimumab biosimilar (Zydus) was safe and effective in patients with ankylosing spondylitis for up to 48 weeks of treatment.
Lastly, a romiplostim biosimilar was evaluated in patients with chronic immune thrombocytopenia, demonstrating the product's biosimilarity to the originator (Nplate).
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.