Samsung reigns over Avastin biosimilar market in Korea

When will it end?

Pfizer and Alvogen receives approval but no news on their reimbursement

Alvogen withdraws application for reimbursement approval…supply amount and patent challenger resutls expected to rise as variable

No new biosimilars of ‘Avastin (Roche, bevacizumab)' are being introduced to the market after Samsung Bioepis’s biosimilar.

 

The Avastin biosimilar market is estimated to have a ₩120 billion market in Korea.

 

In terms of approvals, Pfizer Korea and Alvogen Korea had also received approval for their biosimilars after Samsung Bioepis, but only Samsung Bioepis received reimbursement approval for its biosimilar in September last year.

 

The industry analysis is that the supply amount and results of patent challenges have risen as a variable, delaying reimbursement and release of the other biosimilars.

 

According to industry sources on the 13th, Alvogen Korea withdrew its reimbursement application for ‘Alymsis inj’ that was approved in January this year.

 

With the withdrawal, Alymsis’s reimbursed release in Korea is expected to be further delayed.

 

The industry had previously expected Alymsis to be released with reimbursement in September this year.

 

Alymsys is an Avastin biosimilar developed by the Spanish pharmaceutical company mAbxience that received US FDA approval in April through Amneal Pharmaceuticals.

 

In Korea, the drug will be supplied by Alvogen Korea and marketed by Daewoong Pharmaceutical.

 

The two companies signed an agreement in October last year under which Daewoong Pharmaceutical owns the rights to exclusively distribute and sell Alymsis in Korea.

 

However, a variable - the patent challenge - arose with only reimbursement approval left for its release.

 

Two of Alvogen’s three patent invalidation trials filed by the company were accepted by the court, but one was rejected.

 

The rejected patent is known to be a combined therapy use patent set to expire in 2033.

 

The industry believes that patent challenge results may have affected Alvogen’s reimbursement application withdrawal.

 

However, no news on the reimbursement of Pfizer’s ‘Zirabev inj,’ which was approved before Alymsis, is arising either.

 

Zirabev was approved in May last year.

 

Therefore, speculations are rising that the release date of Zirabev is not being set due to insufficient domestic supply.

 

With the release dates of Alvogen and Pfizer’s Avastin biosimilar unclear, the market preoccupation effect of Samsung Bioepis’s ‘Onbevzi inj,’ the first biosimilar that was released in September last year, has doubled.

 

Onbevzi, which is sold in Korea through Boryung Pharmaceutical, has already passed the review of drug committees at 58 hospitals in Korea.

 

This includes the ‘Big 4’ hospitals in Korea - Samsung Medical Center, Seoul Asan Medical Center, Seoul National University Hospital, and Sinchon Severance Hospital.

 

Based on IQVIA, Onbevzi accounted for 9% of the market in the first quarter of this year.

 

Onbevzi 0.1g/4mL is listed at ₩208,144 in Korea.

 

This is slightly cheaper than Avastin 0.1g/4mL, which costs ₩218.782.

 

Samsung Bioepis has also been emphasizing the economical price of its drug.

 

A company official said, “We will continue to make efforts to provide more treatment options for patients with Onbevzi while contributing to the NHI fiscal-saving effort made by the health authorities in Korea.” Meanwhile, Celltrion had also applied for the approval of its Avastin biosimilar 'CT-P16' in September last year but had not received marketing authorization yet.