Samsung Bioepis’s Lucentis biosimilar approved in Korea

gains market dominance

First-ever biosimilar to be granted marketing authorization in Korea following first-ever approvals in the US (largest market) and Europe

Accumulates multinational prescription data… acquires premium of being the ‘first’ approved

Samsung Bioepis became the first company to receive approval for a Lucentis biosimilar in Korea with ‘Amelivu (ranibizumab).’ Lucentis is a treatment developed by Genetech for ophthalmologic diseases such as macular degeneration and macular edema.

 

With Amelivu’s approval, Samsung Bioepis is now approved for a total of 6 biosimilars in Korea.

 

The company is selling 3 types of autoimmune disease treatments that treat rheumatoid arthritis, etc – ‘Etoloce (Enbrel similar),’ ‘Remaloce (Remicade similar),’ and ‘Adaloche (Humira similar)’ – with Yuhan Corp.

 

Its other two drugs, which are anticancer drugs ‘Sampenet (Herceptin similar),’ and ‘Onbevzi (Avastin similar)’ are sold jointly with Boryung Pharmaceutical.

 

Amelivu’s approval in Korea holds significance in two ways.

 

On the surface, Amelivu will be entering the domestic Lucentis biosimilar market worth 30 billion won as the ‘first drug’ introduced to the market, and will be able to gain market dominance before its competitor, Chong Kun Dang’s ‘CKD-701’ as its review is still in process.

 

From a broader perspective, the approval may act as momentum in penetrating overseas markets.

 

In addition to Korea’s approval this May, Amelivu has been approved in August and September last year in Europe and the US, which allows the company to accumulate real-world prescription data on the drug in various countries.

 

Acquisition of such actual prescription data may facilitate easier approval in other countries in the future.

 

Also, the accumulated evidence (data) can also contribute to the creation of a virtuous cycle that leads to an increase in actual prescriptions in global markets such as the US and Europe.

 

Amelivu’s approval in each country is also directly related to the future of Samsung Bioepis.

 

The company has been recently expanding its business to ophthalmology, endocrine system, and blood diseases.

 

In ophthalmology, in addition to Amelivu, Samsung Bioepis has completed a Phase III trial of its biosimilar for Eylea(SB15), the drug that has been bisecting the market for macular degeneration with Lucentis.

 

An official from Samsung Bioepis said, “We can now expand our business to ophthalmic disease treatments in earnest with our approval of Amelivu in various countries.” Global clinical trial on 705 patients Meanwhile, Amelivu was approved in each country based on the large-scale Phase III study.

 

Samsung Bioepis conducted a global Phase III study comparing SB11 (Korean brand name: Amelivu) with the original from March 2018 to December 2019 in 705 patients with wet (neovascular) AMD.

 

Analysis of the 634 patients among the 705 that continued to receive treatment up to week 52 showed that Amelivu was equivalent (non-inferior) to the original in terms of its efficacy, safety, pharmacokinetics, and immunogenicity.

 

Based on the results, Samsung Bioepis received marketing approval for the drug in Europe in August, in the US in September, and in Korea this May.

 

SB11 will be sold under the brand name ‘Byooviz’ in Europe and the US by Biogen, and its marketing partner and release date in the Korean market is yet unknown.

 

Pursuant to a global license agreement entered into with Genentech, Samsung Bioepis will have the freedom to market the drug in the United States as of June 2022, i.e., before the expiration of Genentech’s applicable SPCs, and elsewhere in other territories after the expiration of Genentech’s SPCs.

 

Increasing macular degeneration market… Epis preoccupies market The blockbuster macular degeneration treatments are ‘Lucentis’ and ‘Eylea.’ Lucentis’s patent is set to expire in July 2022 in Europe, and June 2020 in the US.

 

In the case of Eylea, its patent is set to expire in May 2025 in Europe and in June 2023 in the US.

 

Lucentis is currently sold by Roche and Novartis and has raised 4.4 trillion won in global sales last year.

 

Samsung Bioepis is the first company in the world to receive marketing approval for a Lucentis biosimilar and is competing with European countries including Germany and Sweden in the global market.

 

In Korea, Chong Kun Dang has also conducted a Phase III trial on domestic patients and is being reviewed by the Ministry of Food and Drug Safety.

 

An industry official said, “Samsung Bioepis developed its biosimilar for the two major AMD treatments Lucentis and Eylea in time of their patent expiry.

 

In the case of Lucentis, the company will be able to gain market dominance as it owns the ‘premium’ of being the first approved in Europe, the US, and Korea.”