Is the third Avastin biosimilar coming out?

Alvogen Korea, Celltrion, etc.

Attention is focusing on whether another company will release an Avastin (Bevacizumab) biosimilar approved by Samsung Bioepis and Pfizer.

 

This is because it was found that a new item was approved by the MFDS in August.

 

If the item is approved, a total of four items, including the original Avastin by Roche and three biosimilars, are expected to compete.

 

According to the MFDS on the 24th, a new biosimilar with Bevacizumab, the same ingredient as Avastin, was applied on August 30.

 

The item was found to have applied for permission, excluding ovarian cancer-related indications that could cause patent disputes.

 

Samsung Bioepis' Onbevezy and Pfizer's Jairabeve were also approved except for some of the ovarian cancer indications.

 

This is because the patent will last up to March 2033.

 

Onbevezy and Jairabeve were approved on March 11 and May 17 this year, respectively.

 

Among them, Onbevezy has been on sale by Boryung since September.

 

It is 37% cheaper than the original product, and the expiration date is 36 months long.

 

Pfizer is also expected to release its products in the domestic market soon.

 

The fact that another biosimilar is aiming for the domestic market also appeared in the recent patent challenge trial.

 

Alvogen Korea filed a trial for invalidation of Avastin's ovarian cancer-related patent in August.

 

Alvogen is reportedly planning to release biosimilars in Korea.

 

However, it is analyzed that it may not be an item developed by Alvogen.Samsung Bioepis has also been participating in the patent invalidation trial.

 

Celltrion has also terminated phase 3 clinical trials of "CT-P16," an Avastin biosimilar, and is in the process of product approval.

 

Including Alvogen Korea and Celltrion, there are five domestic Avastin biosimilars.

 

As Avastin is with a performance of about 120 billion won in Korea alone, competition for market share is expected to be fierce.

 

Amgen, Samsung Bio, and Pfizer are already competing in the European market.

 

On top of that, as Beringer Ingelheim and Celltrion are about to be approved, competition for biosimilars is expected to be fierce in the Avastin market.