The launch of Eli Lilly's 'Mounjaro,' which is called a 'miracle weight-loss drug' and garnered global attention alongside Wegovy, in Korea, is imminent.

With the domestic launch of Mounjaro scheduled for mid-August, competition in the obesity treatment market, besides diabetes, is entering a new phase.

There is significant interest in the sales and marketing strategies that Eli Lilly Korea will employ to challenge Novo Nordisk's Wegovy, which was launched in the domestic market approximately a year earlier.

According to pharmaceutical industry sources on August 7, Eli Lilly Korea is set to launch the GIP/GLP-1 dual agonist Mounjaro Prefilled Pen Inj (tirzepatide), hereafter referred to as Mounjaro, in 2.5 mg and 5 mg dosages for patients with type 2 diabetes and obesity in mid-August.

Mounjaro is the first and only GIP (Glucose-dependent Insulinotropic Polypeptide)/GLP-1 (Glucagon-like Peptide-1) receptor dual agonist. It is a single-molecule injectable designed to selectively bind to and activate GIP and GLP-1 receptors, allowing for once-weekly administration. It helps lower blood sugar by promoting insulin secretion, improving insulin sensitivity, and reducing glucagon concentration. Additionally, it aids in weight loss by delaying gastric emptying, which in turn reduces food intake.

In Korea, Mounjaro is approved as an adjunct drug to diet and exercise for improving glycemic control in adult patients with Type 2 diabetes (as monotherapy or combination therapy). It is also approved as an adjunct to a low-calorie diet and increased physical activity for chronic weight management in obese adults (initial BMI≥30kg/m2) or overweight adults (initial BMI≥30kg/m2) with at least one weight-related comorbidity (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).

For both indications, the recommended starting dose is 2.5mg once a week (intended for treatment initiation and not for glycemic control or weight management). After four weeks, the dose is increased to 5mg once a week. If further dose adjustment is needed, the dose is increased by 2.5 mg after at least four weeks at the current dose, with a maximum dose of 15 mg once a week.

Meanwhile, Eli Lilly Korea has decided to initially launch the 'pre-filled pen' formulation, which was first approved in 2023, amid delays in the approval of the vial and QuickPen formulations. This is interpreted as a strategy first to release the pre-filled pen formulation and subsequently launch the other formulations once their ongoing approval process is complete.

Following the launch of Mounjaro, Eli Lilly Korea plans to implement a comprehensive sales and marketing strategy, which will include hosting symposium for medical professionals at major hospitals and clinics starting in late August.

Consequently, the clinical community's attention is focused on Mounjaro's pricing. Since obesity treatment is not reimbursed, Mounjaro's supply price will be a critical factor.

According to the pharmaceutical industry, Mounjaro is expected to be supplied at around KRW 278,000 for the 2.5mg dose (4PEN) and approximately KRW 369,000 for the 5mg dose (4PEN).

This pricing is interpreted as a strategic move, considering that Novo Nordisk Pharma's Wegovy (semaglutide) was priced at KRW 372,025 per month for all dosages when it was launched in Korea last year.

It's believed the 5mg dose was strategically priced to compete with Wegovy. Consequently, it's expected that doctors will also consider the drug's supply price when setting the average monthly price for non-reimbursed treatments.

For reference, patients typically pay an average of KRW 500,000 to 600,000 per month for Wegovy as a non-reimbursed treatment at clinics. Given this, the non-reimbursed price for Mounjaro 2.5mg is likely to be lower than that of Wegovy, while the 5mg dose may be similar to Wegovy's monthly cost.

Cheol Jin Lee, Chairman of the Korean Society for the Study of Obesity (Good Family Clinic), stated, "The vial and QuickPen formulations need approval, but it seems that the Ministry of Food and Drug Safety's (MFDS) approval is delayed." Lee added, "If the vial formulation is also launched in Korea, it would offer a significant pricing advantage. As far as we know, Mounjaro will initially be released in a pre-filled pen format, which is a disposable injectable form."

Lee noted, "Since the efficacy of this drug was confirmed in clinical trials, if it is launched, it will likely be used primarily for new patients." He explained, "This is because it would be difficult for patients who are already on high-dose Wegovy to switch to Mounjaro, which starts at a 2.5mg dose. When considering efficacy and other factors, we would likely consider Mounjaro for new patients if it is launched."

With Mounjaro's launch, the focus shifts to its competition with Wegovy in clinical practice.

Novo Nordisk is also actively ramping up its sales and marketing efforts as the first anniversary of Wegovy's domestic launch approaches. In addition to its in-house sales team of around 80 people, the company is reportedly considering a joint sales and marketing strategy with a domestic pharmaceutical company.

Chong Kun Dang is a strong candidate being discussed within the pharmaceutical industry as a domestic sales partner. However, Novo Nordisk's position is that while they are pursuing collaboration with a domestic pharmaceutical company, nothing has been finalized.

At the same time, Novo Nordisk is also seeking to expand Wegovy's indication to adolescents aged 12 and older. If this becomes a reality, it would give Wegovy a differentiated competitive edge over Mounjaro in domestic clinical practice, primarily because adolescent obesity has emerged as a significant social issue.

Eli Lilly Korea has also established its own sales force, and like Novo Nordisk, is open to collaboration with domestic pharmaceutical companies.

Although several companies, including Hanmi Pharm, are being mentioned, Lilly is expected to focus on Mounjaro's launch for the time being.

In this context, the pharmaceutical industry is also closely monitoring Eli Lilly Korea's efforts to secure reimbursement for Mounjaro's diabetes indication. There is great interest in whether it will be recognized as an innovative new drug, alongside its competitor, Ozempic.

This contrasts with Novo Nordisk's strategy, which involves applying different indications for a single product as part of its reimbursement strategy.

An official said, "We have applied to the Health Insurance Review & Assessment Service (HIRA) for national health insurance coverage and are currently awaiting consideration from the DREC." They added, "As the first GIP/GLP-1 receptor dual agonist and a new treatment for type 2 diabetes, we expect Mounjaro to provide differentiated clinical value. Therefore, we are doing our best for it to be the first chronic disease drug to receive flexible application of the ICER value for innovative new drugs."

A pharmaceutical industry official, who requested anonymity, expressed doubt about whether Mounjaro could meet the government's definition of innovation. They said, "Of course, this doesn't mean Mounjaro has no innovative value. However, we need to verify whether it meets the criteria and definition of innovativeness that the government has established. Ultimately, the question of whether it can be applied will inevitably follow."

An official also said, "We are curious about how the drug price will be set if one treatment is covered for diabetes but not for obesity," and added, "With Ozempic also pursuing reimbursement with a target of the first half of next year, this issue will become a new topic of discussion."