We sat down with Sarfaraz Niazi, PhD, an adjunct professor and biosimilar industry expert, to discuss the potential impact high-concentration adalimumab products could have on the US market.
Reference adalimumab (Humira), developed by AbbVie was approved by the FDA in December 2002 and quickly became a blockbuster drug used to treat 12 rheumatic and inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Biosimilar competition overseas has eroded much of AbbVie’s international market share. Humira’s patent thicket and settlements have shielded the drug from US market competition posed by biosimilars until 2023. Additionally, AbbVie developed and received approval for a high-concentration, citrate-free formulation, which has rapidly become the dominant form of adalimumab, posing an additional challenge to biosimilar competitors.
However, Celltrion Healthcare and Alvotech are positioning themselves to be the leaders in high-concentration, citrate-free adalimumab biosimilars, with Celltrion getting the greenlight Yuflyma in mid-February 2021 from the European Union to enter the market. With new versions of adalimumab on the horizon, what will this mean for the market and the biosimilars already marketed and in the US’ pipeline?
We sat down with Sarfaraz Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of Karyo Biologics, Adello Biologics, and PharmSci, to discuss the implications for the adalimumab market and patients.
To learn more about Celltrion's EU approval, click here.
To learn more about Alvotech’s high concentration adalimumab, click here.
To learn more about high-concentration citrate-free adalimumab products, click here.
To learn about the patent dance, click here.