Korean biosimilar market: a big upward trend

South Korea has emerged as one of the strategic country for the development of biosimilars, that too on the global level. It is one of the most promising countries where pharmaceutical companies have identified huge investment potentials for R&D process. Offering the advantages of favourable government and business conducive environment (including tax holidays, tax concessions, cash grant, site location support etc.), the South Korean biosimilars market particularly is poised for significant and rapid growth in the coming years. It has truly become the growth engine of the country attracting huge investments from public and private companies located in and outside Korea. At the same time, locally developed biosimilars are steadily gaining a larger market share in the Korean pharmaceutical sector.

Hinting at how Korea specifically managed to rise to such a stature in the world of biologics, TH Kim, president & CEO of Samsung Biologics did comment for a press, “The western companies began five or six years earlier than the Korean companies. However, we have caught up and dramatically cut our approval times. People often ask me how this was possible. The answer is that we went “all in” – complete dedication to the market. Once we chose to specialise in biosimilars, there was no room to survive if we failed with the few projects we had”.

Samsung Bioepis has the largest number of approved products by the FDA and EMA, followed in second place by Celltrion. One of the main issues facing developers of biosimilars is the bottleneck surrounding global approvals. “In my opinion, many companies either fail to gain approvals, or the process is delayed because of their inadequate manufacturing facilities” hypothesized TH Kim. He continued by saying, “Although over 100 companies have products that have received approval by either the EMA or the FDA, most do not possess the capacity for production and have failed to improve their facilities and operation technologies in line with their R&D advancements”.

Traditional Korean pharmaceutical companies, such as Chong Kun Dang, Dong-A ST, and Samchundang Pharmaceutical, are accelerating their entry into the biosimilar market.

Chong Kun Dang

Chong Kun Dang received approval for two biosimilars, each in oncology & ophthalmology - Nesbell (darbepoetin alpha) in 2018 & LusenBS (ranibizumab) in 2022, respectively. Chong Kun Dang aims to target the Korean market for ranibizumab worth 32 billion won (25m USD) & Southeast Asia and the Middle East, which is worth about 200 billion won (150m USD).

Dong-A ST

In 2014, Dong-A ST signed an out-license agreement with Japan's Sanwa Kagaku Kenkyusho (SKK) for the development and sales of darbepoetin biosimilar DA-3880 in Japan. After obtaining approval for manufacturing and sales in Japan in 2019, DA-3880 successfully settled in the Japanese biosimilar market, achieving sales of 8 billion won in 2020 and 12.5 billion won in 2021.

Dong-A ST has also completed the global phase 3 clinical trial of Stelara biosimilar DMB-3115 (ustekinumab) in November last year. It is one of the highest-grossing biologics in autoimmune markets, recording $16.8 billion in sales worldwide in Q3 2022. Dong-A ST plans to apply for product approval of DMB-3115 in the U.S. and EU in the first half of this year after completing the analysis of the phase 3 clinical trial and securing positive data.

Sam Chun Dang Pharmaceutical

Sam Chun Dang Pharmaceutical completed the global phase 3 trial of SCD411 (aflibercept), in Q3 2022 for treatment of macular degeneration. Sam Chun Dang plans to receive permission first in Japan, and then apply for permission sequentially in the U.S., Korea, and Europe.

The turning point for biosimilar makers

Initially, biosimilars failed to make a splash in the domestic market, unlike in Europe and the U.S. One of the key reasons being, in Korea, when a biosimilar is launched, the price of the originator drug is automatically reduced due to the nation’s drug pricing policy. Plus, Korean patients strongly preferred the originator brand. But manufacturers like Samsung Bioepis and Celltrion have earned the trust of doctors and patients by focusing on R&D and continuing to release new products. Noteworthy examples are biosimilar versions of Enbrel (etanercept), Amgen's autoimmune disease treatment, & those referencing Herceptin (trastuzumab), Genentech's breast cancer and metastatic gastric cancer treatment, have drastically increased their market shares over the past few years.

IQVIA data showed that Enbrel biosimilar products accounted for 44 percent of the total market sales in 2022, with 8.1 billion won ($6.1 million). Two Enbrel biosimilars are on the Korean market -- LG Chem's Eucept and Samsung Bioepis' Etoloce. Herceptin biosimilars include Celltrion's Herzuma and Samsung Bioepis' Samfenet. Last year, sales of Herzuma and Samfenet were 29 billion and 5.6 billion won, with sales of Herzuma increasing 3.7 times in five years and Samfenet increasing 2.5 times in four years from 2.2 billion won in 2019. The original, Herceptin, on the other hand, saw a 25 percent drop in sales.

Clearly the South Korean government's plan to promote the biosimilars industry and invest in the biosimilars market is showing strong indicators of success. The Korean believes that it can be successful in taking a bigger chunk of the biosimilars market by being price competitive, and relies more on biosimilar products, which has lower development costs compared to novel biologics. Unlike generics that failed to advance to the global market, the industry wants to be aggressive with the biopharmaceutical projects and aspires to become a leader in that space.

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