The recent FDA approval for Cimzia marks UCB’s entrance into the immuno-dermatology market, a competitive field in which Cimzia could find a niche space. However, there are a number of safe and efficacious biologics in the psoriasis market, and Cimzia could struggle if it is not well received by prescribing physicians and dermatologists, says GlobalData, a leading data and analytics company.
On 28th May 2018, the FDA approved the extension of the label of UCB’s tumor necrosis factor (TNF) inhibitor Cimzia (certolizumab pegol) for use in adults with moderate-to-severe plaque psoriasis. Plaque Psoriasis is an inherited disease that typically causes patches of skin that are dry and red characteristically found on the scalp, elbows, and knees.
Although Cimzia marks the fourth TNF inhibitor to be approved for the treatment of psoriasis, Cimzia is the first Fc-free biologic to be approved by the FDA. GlobalData anticipates Cimzia will face strong competition from the widely used branded anti-TNFs, including AbbVie’s Humira, Amgen and Pfizer’s Enbrel, and Johnson and Johnson’s Remicade, not to mention their respective biosimilars.
More recently, IL-12/23 inhibitors and IL-17 inhibitors have been approved for use in moderate-to-severe psoriasis patients, marking a challenging market for UCB to compete in. That being said, GlobalData believes that Cimzia could be a safe and attractive therapeutic option, as its efficacy and safety have been investigated in pregnant and breastfeeding women.
This meets a significant unmet need in psoriasis patients, as there are limited safe and efficacious drugs available for this patient population. In addition, IL-17 and IL-23 inhibitors have not been tested for safety and efficacy in pregnant and breastfeeding women.
Vikesh Devlia, MSc, Pharma Analyst at GlobalData comments, “Cimzia has the potential to capture a share of patients who are not well suited to currently available biologics. However, UCB will need to capture a share of psoriasis patients that are pregnant and breastfeeding in order to be successful.”