Drug maker Alvotech announced today that it has begun enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira. Alvotech says that it has enrolled its first patient, and it plans to enroll approximately 400 total participants at 30 European sites in the study of AVT02 versus the reference product in patients with chronic plaque psoriasis.
Drug maker Alvotech announced today that it has begun enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira. Alvotech says that it has enrolled its first patient, and it plans to enroll approximately 400 total participants at 30 European sites in the study of AVT02 versus the reference product in patients with chronic plaque psoriasis.
A phase 1 study of the safety, tolerability, and pharmacokinetics of the proposed biosimilar is already underway in Australia.
Alvotech notes that its formulation of the proposed drug contains a high concentration of adalimumab, which it says could be more convenient for patients based on the potential for a reduced injection volume. If the drug is eventually approved, its concentration could prove to differentiate the product from a host of competitor biosimilars that are already on the market in Europe and that will enter the United States in the coming years.
Fausto Berti, PhD, Alvotech’s senior vice president and head of clinical and late-stage development, said in a statement that “the initiation of this [phase 3] study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases by providing high-quality biosimilars. Specifically, with AVT02 containing biosimilar adalimumab at high concentration…we hope to reach future patients with a more convenient, cost-effective version of adalimumab.”
Announcement of the phase 3 study comes shortly after the Iceland-headquartered biosimilar developer announced that it had raised $300 million, through a private bond offering, to allow it to further develop its biosimilar pipeline and refinance debt.
The biosimilar developer has also recently announced partnerships with companies including Fuji Pharma, which will commercizlize Alvotech’s biosimilars in Japan, and Changchung High & New Technology Industries Group, which will sell the products in China.
In order to keep pace with its anticipated supply needs, Alvotech recently built a new state-of-the-art biopharmaceutical facility in Iceland, which was granted licensure by the Icelandic Medicines Agency, together with the Irish Health Products Regulatory Authority, in 2018. Additionally, the company owns manufacturing plants in Germany and Switzerland.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
The Role of Biosimilars: Advancing Access, Financial Health, and System Sustainability
March 11th 2024Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the biosimilar industry and the last 5 years of progress.
Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo
March 6th 2024Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.