Latecomer psoriasis drug Bimzelx enters competition in KOR

Targets Korea’s psoriasis market based on its dual inhibiting mechanism of action

Differentiated from existing drugs by inhibiting interleukin-17A and 17F

Insurance reimbursement approved in just 10 months after the company applied for reimbursement in August last year

The new psoriasis treatment Bimzelx (bimekizumab) has cleared the reimbursement hurdle and is now officially entering Korea’s market competition.

 

With numerous psoriasis treatment options already on the market, the drug is expected to target new patients based on its relatively low drug price.

 

On the 12th, UCB Korea held a press conference to celebrate the launch of Bimzelx in Korea and highlighted the product's competitiveness.

 

▲ (From left) Jeong-Eun Kim, Department of Dermatology, Hanyang University Hospital; Stevan Shaw, Head of Research at UCB UK

Bimzelx is the first plaque psoriasis treatment that dually inhibits interleukin-17A and 17F (IL-17A and 17F).

 

IL-17A and IL-17F are key cytokines that trigger the inflammatory process in psoriasis, and Bimzelx selectively and directly targets and inhibits both simultaneously.

 

In the BE READY trial, the global Phase 3 clinical study that became the basis for the approval, 90.8% of patients in the Bimzelx group achieved PASI 90 at Week 16, and 68.2% of patients achieved PASI 100.

 

In a clinical trial that compared Bimzelx with another biological agent, there was a clear difference in the percentage of patients who achieved complete clearance of skin lesions at Week 16, which is referred to as 'PASI 100'.

 

Specifically, ▲BE VIVID: Bimzelx 59%, ustekinumab (Stelara) 21% ▲BE SURE: Bimzelx 60%.

 

8%, adalimumab (Humira) 23.9% ▲BE RADIANT: Bimzelx 61.7%, secukinumab (Cosentyx) 48.9%, etc.

 

The introduction of Bimzelx as a new psoriasis treatment option is significant because of its dual inhibiting mechanism of action that blocks IL-17A and IL-17F.

 

Dr.

 

Stevan Shaw, Head of Research at UCB UK and developer of Bimzelx, said, "Bimzelx’s dual inhibition of interleukin-17A and interleukin-17F showed a higher skin lesion improvement rate in psoriasis patients compared to secukinumab, which only inhibits interleukin-17A.” He further explained, “The dosing regimen, which involves administration every 8 weeks for maintenance therapy, also enhances patient convenience, representing a significant advantage over existing interleukin-17A inhibitors.” In addition, Professor Jeong-Eun Kim of Hanyang University Hospital's Department of Dermatology said, “Even in a meta-analysis conducted over a long period of 52 weeks, Bimzelx showed better efficacy than other drugs in terms of the cumulative number of days achieving PASI 100.

 

No new safety issues were reported during long-term treatment that continued for over three years, with no special events reported overall.” In other words, despite the emergence of various psoriasis treatments, there is still unmet demand due to resistance and other factors, for which Bimzelx is considered to be competitive.

 

The reimbursement price for Bimzelx, which has been covered by health insurance since June, is KRW 801,332.

 

In order to compare the specific drug prices with existing treatments, it is necessary to consider the dosage and administration, and Bimzelx does not have a significant advantage in terms of cost competitiveness, which is a strategy often chosen by later entrants.

 

Bimzelx is administered subcutaneously at 320 mg (two 160 mg doses) at 0, 4, 8, 12, and 16 weeks, and then every 8 weeks thereafter.

 

Considering that competing treatments have administration schedules ranging from 4 weeks to 12 weeks, Bimzelx has a moderate dosing schedule.

 

Regarding this, Professor Kim stated that prescriptions will be tailored to individual patient characteristics and the doctors’ discretion.

 

He added, “While consideration should be given to the patient's comorbidities and prior treatment history, there is no guideline on which drug must be used as the first or last option based on efficacy.

 

However, as more treatment options become available, the therapeutic paradigm for psoriasis is expected to shift and become more segmented.” Finally, Professor Kim added, “Personally, I think Bimzelx should be considered first for patients who do not respond well to biological agents.”