Alvotech, whose drug candidate AVT02 is being developed as a biosimilar to adalimumab (Humira, AbbVie), enrolled the first patient in a clinical phase 3 study evaluating the product, the company announced in a press release.
Adalimumab, a tumor necrosis factor inhibitor (TNF), is indicated for the treatment of autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, and plaque psoriasis. Adalimumab targets and blocks the TNF protein that contributes to the disease symptoms of autoimmune conditions, such as inflammation and tissue destruction.
AVT02’s formulation contains a high concentration (100 mg/ml) of adalimumab, which is expected to be more convenient for patients compared with other biosimilar products, according to Alvotech.
The objective of the phase 3 study is to compare AVT02 with adalimumab in terms of safety, efficacy, tolerability, and immunogenicity in adult patients with moderate-to-severe chronic plaque psoriasis. According to Alvotech, the study will enroll 400 participants at approximately 30 sites across Europe.
“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,” Fausto Berti, PhD, Alvotech senior vice president and head of clinical and late stage development at Alvotech, said in a prepared statement. “Specifically, with AVT02 containing biosimilar adalimumab at high concentration (100 mg/ml), we hope to reach future patients with a more convenient, cost-effective version of adalimumab.”
Additionally, a separate phase 1 pharmacokinetic study, AVT02-GL-101, with healthy participants is ongoing in Australia and New Zealand.
“We are delighted that, after intensive preparation, our first biosimilar product has enrolled its first patient,” Robert Wessman, founder and chairman of the board, said in the press release. “It is a major step forward in the development of our biosimilars portfolio. By developing a high-quality and cost-effective biosimilar, we seek to give as many patients as possible the opportunity to access this treatment option and provide an opportunity for health care providers around the world to improve patient care and significantly reduce costs.”
Currently, AbbVie’s adalimumab is one of the top-selling prescription medications worldwide, with recorded sales of approximately $20 billion in 2018. AbbVie’s patent protection has attempted to ward off competition from adalimumab biosimilars, which have also been developed by Amgen, Novartis, Samsung Bioepis, and Mylan.
Most recently, the FDA approved adalimumab-adaz (Hyrimoz),
which was developed by Sandoz, a subsidiary of Novartis, in October 2018. However, the product will not be available in the United States until 2023, as a result of patent litigation with AbbVie.
Alvotech enrolls first patient in clinical phase 3 study [news release]. Alvotech. https://www.alvotech.com/newsroom/read/alvotech-enrolls-first-patient-in-clinical-phase-iii-study-involving-biosimilar-version-of-humira
. Accessed March 14, 2019.