Biosimilars Immunology Roundup: July 2023

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).