UCV Korea has launched Bimzelx (ingredient: bimekizumab) for treating psoriasis and is set to challenge the market.

Although existing psoriasis treatments have taken a share of the market, the company will target unmet needs based on the drug's new mechanism.

UCB Korea held a media session on November 20 to celebrate the launch of Bimzelx in South Korea and presented the product's competitiveness in the market.

Bimzelx is the first treatment for plaque psoriasis that bi-specifically inhibits interleukin-17A and 17F (IL-17A, IL-17F). It received the Ministry of Food and Drug Safety (MFDS) approval at the end of August.

IL-17A and IL-17F are cytokines that play a central role in inducing inflammatory cascade in psoriatic diseases. Bimzelx works by simultaneously selecting, directly targeting, and inhibiting both cytokines.

In the Phase 3 BE READY clinical trial, which was the basis of approval, 90.8% of the Bimzelx-treated group reached 'PASI 90' at 16 weeks, and 68.2% of those reached 'PASI 100.'

In a clinical trial comparing Bimzelx to different biological agents, a difference has been observed in the percentage of patients reaching 'PASI 100,' an indicator of complete skin clearance.

In detail, the results have shown ▲59% for BE VIVID Bimzelx, 21% for ustekinumab (Stelara) ▲60.8% for BE SURE Bimzelx, 23.9% for adalimumab (Humira )▲61.7% for BE RADIANT Bimzelx, 48.9% for secukinumab (Cosentyx).

The study results demonstrated that Bimzelx has the advantage of a higher PASI 100 score than previously launched biological agents.

Due to the recurrent and remissive nature of psoriasis as a refractory disease, there remains an unmet need for effective treatments. The introduction of Bimzelx, with a novel mechanism, is being evaluated as a potential addition to the therapeutic arsenal.

"Psoriasis patients seek treatment and expect rapid, strong, and lasting therapeutic effects, which are closely tied to improving their quality of life. Despite the availability of various treatment options, there has been an unmet need for safe psoriasis medications that maintain long-term efficacy," Ki Heon Jeong, Professor of the Department of Dermatology at Kyung Hee University Medical Center, explained.

"Bimzelx has demonstrated superior efficacy to some existing treatments through direct comparison clinical trials. Additionally, its maintenance therapy allows administration at 8-week intervals, offering improved convenience compared to existing IL-17 inhibitors," Hojin Lee, UVB Korea's Medical Strategy Lead, said.

Currently, UCB Korea has entered into a distribution agreement with Geo-Young and is actively preparing for the launch of Bimzelx.

However, given the number of psoriasis treatments already available on the market and covered by national health insurance, the impact of Bimzelx remains uncertain.

Regarding this Professor Jeong stated, "It has been quite some time since biological agents were introduced to the market, yet there are still patients suffering despite having tried all available biologic therapies. Introducing a new treatment option with strong efficacy for patients with severe psoriasis is highly significant."

UCB Korea has emphasized that securing reimbursement is their top priority regarding Bimzelx's market entry.

"Following Bimzelx's approval on August 29, we submitted a reimbursement application to the Health Insurance Review and Assessment Service (HIRA) the next day. While we are still in the early stages, including holding drug briefings, we aim to achieve reimbursement by next year," Il Shim, Executive Director of UCB Korea, stated.

"Since previously approved treatments are in the market, the company is aware of the drug pricing issue. We aim to obtain reimbursement for the drug quickly," Shim added.