HER2 targeted therapy market exceeds KRW 200 billion

Roche launches follow-on drugs like Perjeta and Kacyla to defend the sales drop from Herceptin

Biosimilar market share surges up to 29.3% led by Herzuma

The South Korean market for targeted therapy prescribed to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer has exceeded 200 billion won in sales last year.

 

Two domestically developed biosimilars increased the market influence and made up for the sale revenue void in the original by the original maker’s follow-on drugs, such as Kadcyla and Perjeta, breaking the market sales record.

 

On Mar.

 

11, a pharmaceutical market research firm IQVIA reported the trastuzumab drug market size last year dropped to 99 billion won by year-on-year 4.8 percent.

 

The market size increased for two consecutive years since it plummeted from 103.4 billion won in 2016 to 83.6 billion won in 2017, and recovered up to annual sales of 100 billion in 2019.

 

But it took a slight fall after a year.

 

Trastuzumab is the key substance in a targeted therapy Herceptin by Roche.

 

The drug is prescribed to HER2-positive patients with metastatic breast cancer and stomach cancer.

 

In South Korea, two biosimilars of the original Herceptin—Celltrion’s Herzuma and Samsung Bioepis’ Samfenet—were released to the market after the original’s patent expired.

 

The original generated sales of 69.9 billion won last year.

 

Compared against the year before, it was dropped by 11.2 percent.

 

And compared against 103.4 billion won raised in 2016, before the biosimilars were released, one-third of the sales were evaporated.

 

Herceptin’s pricing was brought down by 20 percent, from 517,628 won to 414,103 won per 150 mg injection, two months after Celltrion’s Herzuma was listed for National Health Insurance (NHI) reimbursement in April 2017.

 

And with another pricing drop, the original drug is currently maintaining the pricing at 362,340 won since April last year.

 

By principle of the South Korean drug pricing system, a biosimilar can be priced at 70 percent of the original’s pricing before the patent expiration.

 

And from October 2016, an item ‘developed by a company recognized as an innovative pharmaceutical company or a company with collaborative deal between South Korean and global companies, released first time internationally in South Korea, or manufactured in South Korea’ can be priced up to 80 percent of the original.

 

Meanwhile, an off-patent original’s pricing is reduced to 70 percent to 80 percent of the initial pricing when a biosimilar is launched.

 

The trastuzumab drug market shrunk down to 83.6 billion won due the pricing reduction in Herceptin in 2017.

 

But as biosimilars developed with South Korean technology pushed the sales, the market growth is catching up with the original’s gap.

 

Celltrion’s Herzuma sales last year grew by 10.4 percent from the year before and generated 25.4 billion won.

 

The Ministry of Food and Drug Safety (MFDS) authorized the sales of Herzuma in January 2014 and the drug started making sales revenue from the third quarter of 2017.

 

The 2018 sales was stale with 7.7 billion won, but the sales surged to 23 billion won in 2019 and it is keeping the growth ever since.

 

However, the domestic market share of Samsung Bioepis’ Samfenet is still insignificant.

 

Samfenet generated 3.6 billion won last year.

 

Although the sales grew by 65.8 percent compared to the year before, the gap with the competitor is rather substantial.

 

Currently, Daewoong Pharmaceutical is in charge of Samfenet sales.

 

Within three years of releasing the biosimilars, their market share in the trastuzumab drug market grew exponentially.

 

The two biosimilars took 29.3 percent of the last year’s trastuzumab drug market sales.

 

Herzuma’s share is at 25.7 percent, when Samfenet took up 3.6 percent.

 

Basically, Herzuma led the biosimilar market expansion.

 

And the targeted therapy market for the HER2-positive breast cancer patients expanded vastly as Herceptin developer Roche released follow-on drugs Kadcyla (trastuzumab emtansine) and Perjeta (pertuzumab).

 

Around 15 percent to 20 percent of the total breast cancer patients are confirmed positively with HER2, which has fast relapse and short survival period.

 

Roche’s Kadcyla generated 43.5 billion won last year, growing 22.7 percent from the year before.

 

Kadcyla is the first antibody drug conjugate (ADC) Roche first show cased for the breast cancer sector.

 

The drug can be prescribed to treat unresectable locally advanced or metastatic breast cancer in patients previously treated with trastuzumab and taxane.

 

During the same time, Roche’s Perjeta generated 74.1 billion won.

 

Growing 33.1 percent compared to the year before, the sales surpassed Herceptin for the first time.

 

The drug, in combination with docetaxel and trastuzamab, can be prescribed to patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous HER2 targeted therapy or chemotherapy.

 

As it was listed for selective reimbursement in May 2019, the combination therapy with trastuzumab became the standard adjuvant treatment before a surgery.

 

Five drugs including the three trastuzumab drugs, Kadcyla and Perjeta, have raised 216.6 billion last year together and increased the market by 11.0 percent from the year before.

 

Compared to 116.1 billion won in 2016, the market sales have almost doubled in four years and broke the record.

 

The industry evaluates Roche has overcome off-patent Herceptin’s sales drop with the follow-on drugs.

 

Also the HER2-positive breast cancer patients would benefit from the expanded treatment options.