Ultomiris's reimb ignites competition in gMG mkt

Market landscape shifts dramatically after Ultomiris receives reimbursement approval

FcRn-targeting ‘Vyvgart’ enters reimbursement preparation phase following approval

UCB's Zilbrysq and Rystiggo join in... intensifying competition

Interest is growing in Handok's future launch strategy for Vyvgart (efgatizimod alfa), a treatment for generalized myasthenia gravis (gMG), following the reimbursement entry of its competitors.

Pic of Vyvgart

As a rare disease drug, securing reimbursement is essential. Although its mechanism differs from competitors, Handok plans to move quickly toward reimbursement.

Handok received approval in January for Vyvgart, an imported orphan drug indicated for adult patients with generalized myasthenia gravis who are positive for anti-acetylcholine receptor (AChR) antibodies.

Generalized myasthenia gravis is a chronic, rare autoimmune disease caused by neuromuscular transmission disorders, with approximately 85% of patients possessing autoantibodies against acetylcholine receptors.

When these antibodies bind to the receptor, they activate the complement system and damage the postsynaptic membrane. This structural damage weakens signal transmission from nerves to muscles, ultimately causing neuromuscular transmission failure.

Vyvgart selectively targets IgG homeostasis by preventing pathogenic IgG autoantibodies from binding to neonatal Fc receptors (FcRn), which normally prevents IgG from being degraded by lysosomes. By blocking this binding, Vyvgart promotes the degradation of self-antibodies, thereby demonstrating therapeutic efficacy in patients with autoantibody-mediated myasthenia gravis.

As the first-in-class FcRn-binding therapy approved in Korea, Vyvgart’s entry was expected to expand treatment options for adult gMG patients in Korea.

However, the market dynamic changed abruptly on December 1, when AstraZeneca’s Ultomiris gained reimbursement for the same AChR-antibody–positive gMG population. 

Pic of Ultromiris

AstraZeneca announced that its C5 inhibitor, Ultomiris (ravulizumab), was granted reimbursement starting in December for adult patients with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis.

Although it received approval as a subsequent option after treatment with two or more non-steroidal immunosuppressants prior to Ultomiris therapy, thereby limiting its use, Ultomiris’s rapid reimbursement has drawn significant attention in the clinical field.

Handok signed an exclusive domestic supply agreement with Argenx BV in 2023 for Vyvgart and is in charge of its approval registration, coverage, and exclusive distribution in Korea.

According to the company, having received approval in January this year, it is preparing for the next step – reimbursement discussions. However, it has not yet submitted the documents required to formally initiate the reimbursement listing process with the Health Insurance Review and Assessment Service (HIRA).

While the speed of reimbursement has become important due to competing drugs entering the reimbursement system, Handok maintains a cautious approach given Vyvgart’s novel mechanism of action.

A Handok official stated, “We were closely monitoring Ultomiris' reimbursement process internally, as it is a treatment for the same indication. Since Ultomiris was granted reimbursement for the same indication, we see positive aspects for Vyvgart’s reimbursement listing in Korea.”

“However, Ultomiris already has reimbursement for other indications, and expanded reimbursement to gMG. So it underwent a different reimbursement track from Vyvgart. Vyvgart, being a new drug seeking initial reimbursement, would require more time.”

In short, Ultomiris both intensifies future competition and, at the same time, lowers the reimbursement barrier.

But Handok is not in a position to proceed slowly.

UCB’s Zilbrysq (zilucoplan) and Rystiggo (rozanolixizumab) were approved in November 2024 and April this year, respectively.

Zilbrysq shares a mechanism with Ultomiris, while Rystiggo targets FcRn like Vyvgart.

With UCB aggressively pushing for the drugs’ approval and reimbursement in Korea, Handok also faces pressure to accelerate its efforts to secure reimbursement.

A Handok official stated, “We are actively exploring ways to ensure Vyvgart secures successful reimbursement. Since the conditions under which rare disease treatments receive reimbursement are crucial, we are examining the timing, track, and reimbursement conditions to maximize patient benefit.