Lucentis biosimilars have been applied to the MFDS

Both companies applied for permission around the same time

Along with Chong Kun Dang, Samsung Bioepis also applied for permission to the MFDS for Lucentis biosimilar.

 

Lucentis (Ranibizumab) is a treatment for ophthalmic diseases that treat macular degeneration and various eye damage, and it is a blockbuster with annual global sales reaching ￦4.6 trillion and sales of ￦37 billion in Korea as of last year.

 

According to the MFDS on the 31st, Lucentis biosimilar, a candidate from Chong Kun Dang and Samsung Bioepis, has received an application for permission.

 

Chong Kun Dang announced to the media that it applied for permission for items on the 28th of last month.

 

The company explained that from September 2018 to March this year, 25 hospitals, including Seoul National University Hospital, conducted the clinical phase 3 of Lucentis biosimilar candidate "CKD-701" for 312 macular degeneration patients.

 

Macular degeneration can lead to blindness if the macula, a tissue that accepts light from the retina, loses its function or becomes severe due to aging and inflammation.

 

Chong Kun Dang said it confirmed that there were no statistically significant differences in drug efficacy and other pharmacokinetics, immunogenicity and safety in indicators of less than 15 letters of vision loss and improved vision, average changes in maximum calibration vision, and thickness of the central retina.

 

Samsung Bioepis also completed its domestic clinical trial for Lucentis Biosimilar candidate "SB11 shares" and applied for permission from the MFDS.

 

Samsung Bioepis proved its equivalence with the original drug in phase 3 of the multinational market for 705 people.

 

From March 2018 to December 2019, clinical equivalence and validation criteria were met through comparative studies between SB11 and Lucentis in clinical trials of a total of 705 wet age-related macular degeneration (nAMD) patients.

 

In August, the company received approval for the first Lucentis biosimilar product in Europe.

 

In November last year, the U.S.

 

FDA began reviewing permits.

 

The Korean patent for Lucentis ended in April 2018.

 

As a result, biosimilar can enter the market as soon as it is approved.

 

If the two companies start selling their products around the same time, fierce competition is expected.