Alvogen’s Alymsys reimbursed...compete with Avastin similar

Three-way race between Alvogen’s Alymsys, original Avastin, and Samsung Biologics’ Onbevzi

Sees mixed results in ovarian cancer... Samsung Biologics adds indication, Alvogen’s indication deleted

Celltrion also receives approval in September and aims at releasing its drug with reimbursement within the year

Samsung Bioepis’s Avastin biosimilar

Competition for biosimilars of the anticancer drug Avastin (bevacizumab) is intensifying in the domestic market.

 

Alvogen’s ‘Alymsys’ is making a bid against Samsung Bioepis’s ‘Onbevzi,' which had been dominating the Avastin biosimilar market.

 

With the entry of Alymsys, the original Avastin and its two biosimilars will be competing in the market.

 

According to industry sources on the 11th, Alvogen Korea’s ‘Alymsys inj.’ will be included on the NHI reimbursement list starting this month.

 

The maximum reimbursement price for the 0.1g dose will be KRW 208,144 per vial, the same as Samsung Bioepis’s ‘Onbevzi inj.’ The price of the 0.4g dose was also set at KRW 677,471, the same as Onbevzi.

 

The price of its original, Roche’s Avastin inj is set at KRW 218,782 for the 0.1g dose and KRW 712,098 for the 0.4g, which is slightly higher than its biosimilars.

 

Onbevzi enjoyed a monopoly in the biosimilar market for 1 year after being approved for reimbursement in September last year, and enjoyed a significant preoccupation effect in the market.

 

Its sales, which reached KRW 0.5 billion in Q4 last year based on IQVIA, had continued rising to KRW 1.8 billion in Q1, and then KRW 4.1 billion in Q2.

 

At this rate, its sales is expected to exceed KRW 10 billion only one year since its launch.

 

With the launch of Onbevzi, Avastin’s price was also discounted.

 

With the price reduction, its sales also dropped by KRW 20 billion from the KRW 58.9 billion in 1H of the previous year to KRW 38.1 billion in the 1H this year.

 

Avastin is a targeted therapy monoclonal antibody that is widely indicated for the treatment of various cancers including ▲metastatic colorectal cancer, ▲metastatic breast cancer ▲non-small-cell lung cancer ▲advanced or metastatic renal cell carcinoma, ▲glioblastoma, ▲epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, ▲uterine cervical cancer, etc.

 

Its market size exceeds KRW 100 billion in Korea.

 

Due to its potential, biosimilar companies that had mainly stayed abroad have been launching large-scale marketing activities in the Korean market.

 

However, Avastin’s patent emerged as a variable.

 

Due to the patent, biosimilars were restricted from being used like the original drug, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the ovarian cancer indication.

 

Samsung’s Onbevzi was also unable to obtain this indication due to unresolved patent issues earlier in its release.

 

On the other hand, Alvogen’s Alymsys was approved with the said indication.

 

This is why the release of Alymsys was expected to weaken the competitiveness of Onbevzi in the market.

 

But the situation was once again reversed with Samsung reaching an agreement on patent issues with the original developer Genentech, and Alvogen failing to do so.

 

Samsung recently reached an agreement with Genentech for the patent suit on Avastin, which had been ongoing since June 2020.

 

As a result, the company was able to obtain an additional indication for epithelial ovarian cancer last month.

 

Alvogen, on the other hand, had to delete the indication in August due to a patent dispute and received reimbursement approval for the remaining indications.

 

This is why the reimbursement approval period was delayed by one month.

 

Despite some indication-related issues, many experts expect biosimilars to succeed in the domestic market, considering the high usage rate of bevacizumab in various other cancers as well.

 

Samsung Bioepis entrusted sales of its product to Boryung Pharmaceutical, which is showing prominence in the anticancer drug market, and Alvogen to the large domestic pharmaceutical company Daewoong Pharmaceuticals for its early settlement in the market.

 

In addition, Celltrion also received approval for its ‘Vegzelma inj’ on September 28th and is working to release the drug with reimbursement within the year.

 

Celltrion also reached an agreement on Avastin’s patent with Genetech in May and was approved for the same indication as the original, including ovarian cancer related indication.

 

Until now, Remsima was the only product that showed a good performance in the domestic biosimilar market.

 

It is analyzed that the domestic biosimilar market is also entering full-fledged growth, starting with the Avastin biosimilar.