Wegovy's release on the 15th…competitor Mounjaro

obesity drug Wegovy set to be released in Korea on the 15th... will complete with Mounjaro upon its launch

Ozempic, Wegovy to be used separately for diabetes and obesity indications, respectively…Mounjaro used for both indications

Lilly seeks to adopt strategies to accelerate its product’s market entry

Mounjaro expected to be released in the first half of next year, seeks potential distribution partners

With the release of Wegovy, the next-generation obesity drug, set for the middle of this month (October), the release of its competitor Mounjaro is also gaining attention.

 

Although Lilly has not yet announced a specific launch date for its Mounjaro, the company has opted to add another indication to its drug rather than apply for new drug approval, which is raising expectations on the company’s early launch scenario.

 

Pic of Mounjaro

Novo Nordisk recently announced that it will launch Wegovy (semaglutide) in the Korean market from the 15th of this month.

 

This will be the 9th global launch in a year and a half since the drug was approved by the Ministry of Food and Drug Safety in April last year.

 

With the launch of Wegovy, a representative next-generation obesity treatment, near, attention is also being drawn to the release of Mounjaro (tirzepatide), which was approved by the MFDS in August.

 

As there is a time gap between the global approvals of Wegovy and Mounjaro, the timing of the domestic launch of the two is also set to differ.

 

Even so, the industry is awaiting the release of Mounjaro due to the company’s method of approval.

 

Lilly received approval for its Mounjaro as an adjunct to chronic weight management in June last year, about a year after receiving approval for the type 2 diabetes indication.

 

In the U.S., Lilly received approval for the obesity treatment separately under the brand name Zepbound, just as a separate brand called Ozempic is approved for the diabetes indication of Wegovy.

 

In Europe, as in Korea, Lilly received approval for both the diabetes and obesity indications with one product, Mounjaro.

 

The industry interpreted Lilly's approach as a choice made to accelerate the approval timeline, although it may not necessarily mean an early launch.

 

‘It's much easier to get multiple indications approved for one product if you don't have to brand the product separately,’ said a pharma industry insider.

 

“Given that the drug showed significant weight loss in the diabetes clinical data already showed, and that the product is already approved in the US and Europe, adding an indication to an existing product is faster.” He added, “Adding an indication only requires safety and efficacy review, but new approvals are allocated a longer time allocated for review, including GMP site assessment, which makes a difference in the speed of (approvals).

 

In general, it is rare for an existing product to receive approval for a new indication as a separate product in Korea.” In other words, it's Lilly's choice whether to add indications to a product and seek new approvals, but in terms of speed of approvals, adding indications is much easier.

 

The company is also expected to have considered the fact that MFDS’s inspection timeline for overseas manufacturing sites is scheduled to be after 2027.

 

In conclusion, there is no doubt that Lilly's decision to add an indication for Mounjaro gave the company an option to ‘choose’ the timing of its launch rather than wait for approval.

 

The industry is now speculating on Mounjaro’s launch in the first half of next year, with a shortlist of potential domestic distributors.

 

The idea is that the company will seek to enter the market before Wegovy has a chance to reap the benefits of first-mover advantage.

 

However, the industry believes that the distributors that are being discussed based on their relationship with Lilly or their experience in distributing obesity drugs need to be watched further.

 

In addition, even if Mounjaro is launched immediately, it is a different matter whether sufficient quantities can be supplied to Korea, which also requires review from various aspects.

 

Lilly Korea is of the view that the launch date should be determined before discussing whether to select a distribution partner.

 

“Both Wegovy and Mounjaro are expected to compete with a greater focus on obesity treatment,’ said another pharmaceutical industry insider.

 

“However, as they have different indications for type 2 diabetes and cardiovascular disease, their impact is likely to vary depending on the patient condition.”