The expiration of several biologic therapies for plaque psoriasis (PsO) this year gives these patients some hope for the arrival of more affordable treatment, according to GlobalData. The leading data and analytics company notes that the typical annual cost of biologic therapy in the US is greater than $50,000 per year – an intimidating figure even before considering that 10-15% of people with more serious cases of PsO are forced to discontinue due to lack of efficacy, according to estimates by key opinion leaders (KOLs) interviewed by GlobalData. The onset of biosimilars could help patients save up to $20,000 a year.

Tiffany Chan, Immunology Analyst at GlobalData, comments: “Despite the large number of therapies already available for PsO, several key unmet needs still remain. Firstly, there is a lack of cost-effective treatments and a need for more novel topical ointments and targeted therapies in both treatment-refractory and milder patients alike.

“Secondly, patient access continues to be a significant unmet need, as the high cost of current therapies presents a significant barrier to care. However, several biologic patents are expected to expire in the next few years, allowing manufacturers to begin marketing biosimilars, which should bring these costs down and save patients money.”

Notably, AbbVie’s Humira’s (adalimumab) US patent expiry in 2023 has been much anticipated by both payors and physicians as tumor necrosis factor (TNF) inhibitors remain among the first-line biologics for this indication. J&J’s interleukin (IL)-12/23 inhibitor Stelara (ustekinumab) is also expected to lose patent protection in 2023.

Chan continues: “Biosimilar therapies are expected to be priced at a fraction of the cost of their branded counterparts.”

While the majority of patients appear to be well managed by existing therapies, subgroups at both ends of the disease severity spectrum remain difficult to treat.

Chan adds: “Patients with mild and moderate PsO have limited treatment options, mainly consisting of topical treatments and phototherapy. The development of oral or new topical therapies for mild PsO patients presents ample opportunity for companies interested in entering the space. Not only could these therapies help provide greater symptom control, they may also aid in preventing the progression of disease.”

Currently, KOLs interviewed by GlobalData anticipate that BMS’ deucravacitinib could be poised to meet this need, as its pivotal trials utilize Otezla – a current front-runner among mild and moderate patients – as an active comparator.

Chan continued: “For disease-refractory patients, there are several therapies with novel formulations or novel mechanisms of action in late-stage development. Although there are several IL-17 inhibitors already available, UCB’s IL-17A and IL-17F dual inhibitor, bimekizumab, is expected by KOLs to be a best-in-class drug – based on its mechanism of action and available clinical data.”

Although Amgen’s Otezla offers an oral formulation of a PDE-4 inhibitor, Arcutis’ roflumilast is a topical formulation within the same class. These could present good options for patients who are refractory to available treatments, either as monotherapies or adjunctive to current standard of care.

This is also an opportunity for manufacturers to meet patient demand. Some patients would prefer to not use injectable therapies and prefer topical formulations instead. Even though there are a number of genericized topical treatments available to patients with PsO, there have not been any new developments in topical treatments over the last 25 years.

Currently, Arcutis Therapeutics’ topical phosphodiesterase inhibitor, roflumilast, and Dermavant Sciences’ aryl hydrocarbon receptor agonist, tapinarof, are innovator topical therapies in Phase III development. If approved, KOLs interviewed by GlobalData are confident that these therapies will be seen as alternatives to topical steroids, price notwithstanding.

Additionally, Pfizer’s Janus kinase inhibitor brepocitinib tosylate is being investigated in both oral and topical formulations and is currently in Phase II development.

Chan adds: “Despite the maturity of the PsO market, KOLs interviewed by GlobalData agree that opportunity remains for manufacturers willing to employ more targeted and savvy approaches to the development of new therapies. By attempting to fulfill these specific unmet needs, pharmaceutical companies could generate new treatment options for patients, which could reduce the need for administration and monitoring by healthcare professionals.”