With the launch of seven adalimumab biosimilars, the release of several market trends reports, and results from clinical trials in often-ignored disease states, July was a pivotal month for immuno-biosimilars.
Launch of Adalimumab Biosimilar in the United States
The initial launch in July included four adalimumab biosimilar products: Cyltezo, Yusimry, Hadlima and Hyrimoz.
Cirtezzo is the only compatible adalimumab biosimilar. Usimli is the only biosimilar to have signed an agreement with Mark Cuban Cost Plus Drug Company, an online pharmacy that offers generic drugs at deep discounts to original drugs. Hadrima and Hirimoz have launched low- and high-concentration formulations, respectively.
Celltrion’s Yuflyma was the next adalimumab product to launch. This product is available only as a citrate-free high-concentration formulation with a wholesale purchase cost of $3,288.25 per single-use unit for administration.
The final two products launched in July are Idacio and Hulio, both available only as low-concentration formulations. Idasio is Fresenius Kabi’s first immunological biosimilar and second biosimilar following Fresenius Kabi’s Stimfend (pegfilgrastim biosimilar), which will be launched in 2023. Hulio was originally developed by Viatris. However, Viatris has sold its entire portfolio of biosimilars to Biocon Biologics to help transition to new owners.
Market Insights and Price Changes
The review article provided a fresh perspective on the growing adalimumab market and whether these new products will lead to cost savings for patients. The article highlights product-to-product variability as a concern, including differences in citric acid concentration, high and low concentrations, and dosing equipment.
Additionally, the dual pricing strategy for listing products on formulation lists can cause confusion and increase out-of-pocket costs for patients. The authors made several policy recommendations to ensure patient cost reduction and fair market competition.
Contributed articles written by four pharmacists provided advice to clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and to overcome new administrative challenges. This article emphasized the importance of healthcare systems providing teams with educational materials, familiarizing themselves with the differences between products, and overseeing state laws.
A study evaluating the launch price of Angevita, the first adalimumab biosimilar to be launched in the US, compared to the original product (Humira) found that the list price of the biosimilar was more than double the initial price of Humira turned out to be
This is partly because Humira’s manufacturer, AbbVie, has significantly increased the price of Humira over time to maximize profits before facing market competition. Adalimumab This price differential between the launch price of his biosimilar and the innovator is also seen in Yuflyma, the Hyrimoz brand, Cyltezo, the Hulio brand, and Idacio.
However, a study of price movements in Europe found that prices of tumor necrosis factor-alpha inhibitors such as infliximab, adalimumab and etanercept led to significant price reductions after the first and second biosimilars entered the market. turned out to be
Clinical trial results
In many cases, immune system biosimilars are approved by the FDA using data evaluating the drug in patients with rheumatoid arthritis. However, a recent study evaluating a biosimilar to infliximab found the product to have a safety and efficacy profile similar to the original product (Remicade) in patients with inflammatory bowel disease.
Additionally, an Indian study showed that adalimumab biosimilar (Zydus) was safe and effective in patients with ankylosing spondylitis for up to 48 weeks of treatment.
Finally, a biosimilar of romiplostim was evaluated in patients with chronic immune thrombocytopenia, demonstrating the biosimilarity of this product to its original product (Nplate).
