Daewoong Pharmaceutical announced on the 22nd that it will enter the biosimilar business.
The company appointed Dr. Hong Seung-seo, who is from Celltrion, as the head of the BS institutional sector overseeing the biosimilar business.
Deputy Minister Hong Seung-seo led the entire cycle from research and development to global commercialization of biosimilars at Celltrion and Celltrion Healthcare from 2002 to 2019. He has also served as the president of the research sector at Celltrion, the representative of Celltrion Healthcare, and the representative of LophiBio.
Daewoong Pharmaceutical, which has grown by focusing on synthetic drugs, has turned to biosimilars as a new growth opportunity due to their significant market growth potential. According to the global market research firm Insight Market Research Consulting Group (IMARC Group), the global biosimilar market size was 36 trillion won ($26.5 billion) last year and is expected to reach 250 trillion won ($185.1 billion) by 2033.
Biosimilars can deliver the same effects with less development time and expense compared to new drugs. The development period is shorter than that for new drugs, and the success rate for development and approval is relatively high. In March of this year, the European Medicines Agency (EMA) announced new guidelines allowing approvals based solely on quality data and Phase 1 clinical trials, without requiring Phase 3 trials. The company analyzed that a strategy to reduce development risks and enhance cost competitiveness has become feasible.
However, as more corporations enter the market, competition in the biosimilar sector is becoming increasingly fierce. Among domestic corporations, Celltrion, Samsung Bioepis, and U.S. pharmaceutical companies Amgen and Pfizer, as well as Sandoz, which was spun off from Swiss Novartis, have entered the biosimilar market early.
Daewoong Pharmaceutical plans to rapidly secure global competitiveness based on its research and development, production, marketing, and sales capabilities in protein pharmaceuticals. The company stated that it aims to achieve a higher approval and launch success rate, as well as faster market entry and sales expansion, through close strategic collaboration with domestic and international biosimilar and contract development manufacturing (CDMO) companies, in addition to its own development capabilities.
Deputy Minister Hong Seung-seo noted, "It is very meaningful for Daewoong Pharmaceutical, which has contributed to the health improvement of Koreans over the past 80 years, to challenge the biosimilar market," adding, "I will contribute to providing better treatment accessibility to patients worldwide based on Daewoong Pharmaceutical's sales network and execution capabilities."
Park Seong-su, the representative of Daewoong Pharmaceutical, said, "As Daewoong Pharmaceutical has the experience accumulated through the development and commercialization of various formulations, as well as the capability for global partnerships, we can show differentiated execution not only through in-house development but also through joint development in the biosimilar market."