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).
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
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.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.