Daewoong wins nod for first generic version of Ibrance tab

the market worth KRW 50B, races against Kwang Dong

Has acquired priority marketing authorization following success in patent nullification

Kwang Dong set to launch generic in capsule formulation…set to launch in 2027

Daewoong's first generic for Pfizer's breast cancer treatment, 'Ibrance Tab,' has been approved.

 

Due to the successful patent nullification, the company received priority marketing authorization.

 

The first generic can be launched in March 23rd, 2027, when the product patent expires.

 

The Ministry of Food and Drug Safety (MFDS) has granted approval of Daewoong's "Ranclib tab" 75 mg, 100 mg, and 125 mg.

 

This drug can be used to treat hormone receptor (HR)-positive or HER2-negative metastatic or advanced breast cancer.

 

It is used in combination with aromatase inhibitor as first-line endocrine therapy in women or in combination with fulvestrant after endocrine therapy in women with advanced diseases.

 

Pfizer

Pfizer's Ibrance containing palbociclib is the original medicine.

 

Ibrance was the first CDK4/6 inhibitor to be developed.

 

It was launched with reimbursement coverage in November 2017 through the risk-sharing agreement (RSA).

 

Unlike capsules, tablets can be taken regardless of food.

 

The film-coating of the tablet allows for co-administration with proton pump inhibitors (PPI) or antacids, which are used to manage gastrointestinal disorders or diarrhea that commonly occur in breast cancer patients.

 

Overall, tablets provide easier administration convenience than capsules.

 

Ibrance's 2023 sales were KRW 50.5 billion, according to IQVIA.

 

Due to the drug's high marketability, Korean pharmaceutical companies are attempting at early market entries through patent challenges.

 

In addition to Daewoong, Kwang Dong Pharmaceutical, Boryung, and Samyang have entered patent challenges.

 

After winning the nullification trial for the ingredient patent in March, Daewoong has established a ground to launch generic once the substance patent expires.

 

In addition to successfully winning the patent challenge, Daewoong also acquired priority marketing authorization with approval as it met the requirement for the first generic.

 

The prior marketing authorization period is from March 23rd, 2027, the day after Ibrance Tab's substance patent expires, to December 22nd, 2027.

 

Last year, Kwang Dong Pharmaceutical acquired the priority marketing authorization of 'Alency Cap' for the same period as Daewoong's product.

 

However, Kwang Dong Pharmaceutical won the priority marketing authorization against Ibrance Cap rather than Ibrance Tab.

 

Additional approvals are expected soon as other companies that have challenged the patent have won.

 

At the launch, Ibrance had no competitors in the market for breast cancer.

 

However, the sales are slightly decreasing as similar CDK4/6 inhibitors Kisqali (Novartis, ribociclib) and Verzenio (Lily, abemaciclib) have launched.

 

The analysis suggests that the market size may be downsized upon generic launch.

 

"Although Ibrance generates the highest sales in the CDK4/6 inhibitors market, the sales have been gradually decreasing," pharmaceutical industry personnel said.

 

"Sales could drop even more when generics launch following the substance patent expiration.

 

Korean pharmaceutical companies could have launched generics earlier."