Phase III trial of Eylea biosimilar is ready to kick off

Alteogen's biosimilar is in Phase I trial

Samsung Bioepis is accelerating the development of a macular degeneration treatment, Eylea biosimilar (Aflibercept, Bayer Korea).

 

The development stage is the most advanced in Korea.

 

On the 11th, the MFDS approved phase III global clinical trials for Eylea biosimilar ‘SB15’ by Samsung Bioepis It is phase III trial comparing the effectiveness, safety, pharmacokinetics and immunogenicity between SB15 and Eylea in subjects with neovascular age-related macular degeneration.

 

As a multinational clinical trial, 66 out of 446 subjects participated in Korea.

 

Clinical trials are conducted at Kyunghee University Hospital, KUMC, KU Ansan hospital, Nune Eye Hospital, Pusan National University Hospital, Bundang Seoul National University Hospital, Samsung Medical Center, YUMC, Haeundae Paik Hospital, and AMC.

 

Eylea, along with Lucentis, is the world's most used treatment for macular degeneration.

 

It was released in July of that year with domestic approval in March 2013.

 

As of IQVIA, 2019 domestic sales amounted to ₩46.8 billion.

 

The domestic market outperformed Lucentis (Novartis), which recorded ₩30 billion.

 

Domestic indications include not only for the treatment of neovascular age-related macular degeneration, but also for the treatment of vision damage caused by retinal vein obstructive macular edema/diabetic macular edema and by choroidal neovascularization due to pathological myopia.

 

The domestic related patent (Modified chimeric polypeptide with improved pharmacokinetic properties) is expected to expire on January 9, 2024.

 

There is no commercially available Eylea biosimilar to date.

 

SCD Pharm and Alteogen are developing along with Samsung Bioepis in Korea.

 

SCD Pharm was approved for phase III clinical trial by the US FDA in May.

 

However, domestic clinical trials have not yet been approved.

 

Alteogen was approved for clinical trial I by the MFDS in May last year, and was administered to the first patient in February.

 

Eylea Biosimilar by Alteogen will be manufactured and supplied by DMBio and will be sold in the domestic market by Hanlim Pharm when commercialization and development are completed.

 

Samsung Bioepis is the first phase III trial in Korea.

 

Since 2017, Samsung Bioepis has also been conducting phase III clinical trials of the Lucentis biosimilar, which is the competitive drug of Eylea, and is expected to be approved soon as it is said to have been completed at the end of last year.