The most common treatment for autoimmune conditions such as ankylosing spondylitis, plaque psoriasis, Crohn’s disease, juvenile idiopathic arthritis, and rheumatoid arthritis is currently a drug called Humira, created by AbbVie. It has one of the highest number of sales across the world of any medication. In 2018 alone, AbbVie made 20 billion dollars in Humira sales. Unfortunately, this means it’s not cheap for patients.
Other companies have been working to develop a biosimilar product which would be cheaper but just as effective for patients. However, AbbVie’s product is patent protected, aiming to save them from biosimilars. These have been created by Mylan, Novartis, Samsung Bioepsis, and Amgen. For instance, a biosimilar created by Novartis (adalimumab-adaz) was approved by the FDA just a short time ago however, because of AbbVie’s patent, it won’t be available in the U.S. until 2023.
Most recently, Alvotech has created AVT02. The company has just announced that they’ve enrolled the very first patient in their Phase 3 clinical trial of the drug and they’re excited about its potential.
AVT02 contains a high concentration of biosimilar adalimumab (100 mg/ml) which is the active ingredient in Humira. Alvotech suspects that AVT02 will be more convenient for autoimmune disease patients compared to other biosimilar products because of this high concentration. Additionally, they believe it will be more cost-effective.
Their Phase 3 trial will compare AVT02 directly with adalimumab. It will evaluate the safety, tolerability, immunogenicity, and efficacy of the product in 400 patients who have chronic plaque psoriasis (ranging from moderate to severe). This trial will be conducted at 30 different sites in Europe.
In addition to this study, Alvotech has an ongoing Phase 1 study investigating the pharmacokinetics of AVT02 in healthy volunteers. This study is being conducted at locations in New Zealand and Australia.
This new Phase 3 trial by Alvotech is exciting for this patient population because it could mean a cheaper treatment option could be coming to the market in the near future. The company believes that AVT02 will help more patients access the medication they need without sacrificing any quality. Ultimately, ATV02 could improve patient care and patient’s quality of life.
You can read more about this new potential therapy here.