바이오스펙테이터

by Jongwon Jang

Sustainable Growth through Harmony in Reinforcement of Pipelines and Efforts for Maximizing Sales and Cost Reduction”.

Samsung Bioepis declared the “Sales of 1-trillion KRW with business in the black” for the first time at the point of two months before the end of 2019. This will be a milestone in the business history of biosimilar products of Samsung Bioepis accomplished 8 years after it was founded in 2012.

President Christopher Hansung Ko of Samsung Bioepis provided reporters and newswriters with a social gathering in the ‘BIOplus 2019’, held on November 12 at COEX, Seoul Korea, and stated, “… the company will be in the black this year for the first time!”.

The cumulative sales amount of Samsung Bioepis, up to the third quarter of this year, already exceeded the sales amount of last year. Samsung Bioepis remained in the red of approximately 100 billion KRW last year. However, the company realized an operating income of 41,700 million KRW in the first half of this year. If this trend continues, this year's profit turns positive.

The sales amount of biosimilar products, developed by Samsung Bioepis, is estimated to be 1-trillion KRW. He explained, “… we are witnessing a sales increase with cumulative sales amount of therapeutic agent for autoimmune disease (Biogen) in the European market, which has already reached approximately 650 billion KRW up to the third quarter this year …”.

In addition, the inclusion of sales amount of biosimilars for breast cancer together with therapeutic agent for autoimmune disease sold in the United States of America by another partner company, the MSD(Merck in America), is expected to reach 1 trillion KRW. He said, “… the biotech start-ups, such as Amgen or Gilead, spent over 20 years to accomplish sales amount of 1 trillion KRW since its foundation …”, “… I am happy and proud that Samsung Bioepis can reach sales amount of 1 trillion KRW in 8 years…”.

Samsun Bioepis currently sells four kinds of biosimilar products in Europe, America, and Korea. In particular, the presence of ‘Benepali (Biosimilar of Enbrel, Etarnercept)’ and ‘Imraldi (Biosimilar of Humira, Adalimumab)’ in the market is significant.

‘Benepali’ recorded cumulative sales amount of approximately 1.5 trillion KRW since its release into the market in 2016. Currently it exceeds the market share of original product in the market of five major countries in Europe (EU5: United Kingdom, Germany, France, Spain, and Italy).

Imraldi is a biosimilar of ‘Humira’, which is sold most frequently in the global market. It was released into the European market last October together with products of competitors such as Amgen, Sandoz, and Mylan. Upon the release of ‘Imraldi’ into the market, it recorded annual sales of 170 billion KRW. Samsung Bioepis dominates the market share in markets of biosimilars of Humira based on its capacity of supply and know-hows attained from existing therapeutic agent of autoimmune diseases.

President Ko also commented on the possibility of degrading profitability of biosimilar of ‘Humira’ due to intensified competition, “… the price of product would fall in accordance with increasing competition, however it remains on the predicted level …”, “… the trend of price decline is yet moderate, the current margin in the price is still reasonable…”. He added, “… companies supplying biosimilar products would be sustainable if they have price competitiveness and capability of securing quality of products in mass production system…”, and emphasized as follows, “… besides developing another products for purposes of cost reduction, (Samsun Bioepis) also improves the process of existing products released into the market continuously ...”.

He stated at the gathering, “… we are currently developing therapeutic agents for eye- and rare diseases besides for autoimmune diseases and anticancer agent that are currently on sale; we will also start to develop a therapeutic agent for musculoskeletal disease.”

Samsung Bioepis currently has SB11 (Biosimilar of Lucentis, Ranibizumab) and SB15 (Biosimilar of Eylea, Aflibercept) that are ophthalmiatric agents. It also has SB12 (Biosimilar of Soliris, Eculizumab) as a therapeutic agent for rare diseases. In particular, the company prepares for making inroads into global markets through developing partnership for sales and marketing with Biogen in America and with companies in Europe.

President Christopher Hansung Ko added comments on the business outlook of the coming year, “… we are going to prepare for the approval of sales of SBB (Biosimilar of Avastin, Bevacizumab) and SB11, and we are anticipating for the release of products approved by each country…”.

Samsung Bioepis filed the application for sales of SBB to European Medicines Agency (EMA) last July. It currently is in the last stage of Phase 3 Clinical Trial of SB11. Currently, the company expands its business domain continuously with the contract for license to sale, with 3SBio concluded for the second largest market of China, together with concluding contract of supply of ‘Brenzys’ (Biosimilar of Enbrel, Etarnercept) for 10 years in Brazil, the biggest market in South America.

President Christopher Hansung Ko stated, “… we are able to accomplish the business in the black through support for the infrastructure capable of developing simultaneous and multilateral portfolio, together with efforts of all staff …”, and emphasized, “… we will increase the profit through efforts of maximizing sales, developing pipelines, and attaining approvals of more products next year…”.

President Christopher Hansung Ko finalized, “…we will provide the public with substantial accomplishment next year through deliberating on ways for the simultaneous growing of the industry of bio-business. We will do our best as a leader among biopharmaceutical companies in Korea…”.