Galderma is challenging the Korean market for atopic dermatitis treatment with its first biologic, 'Nemluvio (nemolizumab).'

Given the market's already competitive nature, Galderma is likely to secure a market presence with the drug's mechanistic differentiation, convenient administration, and expanded indication.

Galderma Korea submitted an application for Nemluvio's Korean marketing authorization to the Ministry of Food and Drug Safety (MFDS) in August of last year. The company expects to obtain approval by the end of the fourth quarter of this year.

Nemluvio's indications submitted for marketing authorization in Korea are two types: atopic dermatitis and prurigo nodularis.

Approval of Nemluvio gathers attention because it is the first biologic from Galderma Korea.

While Galderma has supplied ethical-the-counter (ETC) drugs such as acne treatments and botulinum toxins to the Korean market, most of these have been topical agents or aesthetic products. In that context, approval of nemolizumab for the atopic dermatitis indication is significant in terms of portfolio expansion.

However, the current situation for nemolizumab, as a latecomer, is not easy given that global big pharma companies are fiercely expanding their presence in the severe atopic dermatitis treatment market in Korea.

Starting with Dupixent, a biologic like nemolizumab, and followed by JAK inhibitors, as well as LEO Pharma's Adtralza and Lilly's Ebglyss, these drugs are also expanding their influence in the market.

In the market for atopic dermatitis, where strong early entrants have been introduced, the key competitive advantage for Galderma's nemolizumab is projected to be its 'mechanistic differentiation.'

Nemluvio is the first drug to inhibit the IL-31 pathway, which is central to itching, rather than the IL-4/13 or IL-13 pathways targeted by existing biologics.

By binding to the IL-31 receptor alpha (IL-31RA) and blocking the itching signal itself through neuronal transmission, it is expected to provide a rapid and robust improvement in pruritus compared to existing drugs.

The efficacy of Nemluvio was demonstrated in the multi-national Phase 3 clinical trial, the ARCADIA program.

In a comparison study against topical corticosteroid (TCS) combination therapy, involving a total of 1,728 patients with moderate to severe atopic dermatitis, both the EASI-75 achievement rate and the itch improvement index (NRS)showed significant improvement at 16 weeks, meeting the co-primary endpoints.

Furthermore, the administration method was designed with patient convenience in consideration, involving subcutaneous injections every 4 weeks, and a pre-filled pen for self-administration has also been secured. This method offers the advantage of a lower medication burden compared to treatments that require administration once every two weeks or daily oral intake.

Galderma is also accelerating the global launch of nemolizumab. Following obtaining initial approval in Japan at the end of 2023, nemolizumab was approved in Europe and the United States for the prurigo nodularis indication earlier this year.

This strategy targets a niche market that shares a similar immunopathologic structure with atopic dermatitis but has had limited treatment options available.

Indeed, Galderma is differentiating nemolizumab as a dual-indication product for treating both prurigo nodularis and atopic dermatitis, attempting to distinguish its marketing strategy in a market with high entry barriers.

However, for Galderma Korea, as a latecomer, challenges remain, including initial price barriers and the uncertainty of reimbursement listing.

That is, whether or not it achieves reimbursement is considered a crucial variable for its success or failure. This is a pattern that has been repeated with previous competitor drugs.

Given that it is a latecomer compared to existing drugs, the drug pricing evaluation process is likely to be complicated. How Galderma designs its non-reimbursement marketing or specialized sales targeting healthcare professionals in preparation for this will be key.

Additionally, nemolizumab is expected to test Galderma Korea's capabilities in building hospital and specialized channel networks in the Korean market. For Galderma, whose primary business has focused on aesthetics and general dermatology, this presents new challenges.

How nemolizumab can quickly be established as an 'essential drug' among healthcare professionals and patients and gain market presence in Korea is expected to become clearer during the approval process in the second half of this year and the launch preparation in 2026.