Celltrion leads biosimilars deals landscape in South Korea, finds GlobalData

South Korea has emerged as a global leader in the biopharmaceutical industry, driven by its advanced clinical research infrastructure and government support. Key companies like Celltrion and Samsung Bioepis dominate the biosimilars market, contributing significantly to the approvals and pipelines. Celltrion’s strong presence in deal-making further underscores South Korea’s growing influence in the global biosimilars landscape, reveals GlobalData.

According to GlobalData’s Pharmaceutical Intelligence Center, 24 biosimilars from South Korean companies are approved across various geographies, of which 11 are monoclonal antibodies (mAbs). Additionally, five biosimilars are in the pre-registration stage for 10 different therapy areas.

Samsung Bioepis has the largest number of approved products by the FDA and EMA, followed by Celltrion, which is the world’s first to get approval for a biosimilar therapy with Remsima (infliximab), a copy of Janssen Biotech’s Remicade.

Nelluri Geetha, Pharma Analyst at GlobalData, comments, “South Korea has a long history in manufacturing biologicals and a regulatory pathway for biosimilars was introduced in South Korea in 2009. The government’s support for the biosimilars industry, as well as major investments by top companies, have contributed to the rapid growth of the domestic biosimilar market in South Korea.”

Over the last five years (2020 to 2024#), nine deals have happened between global pharma and South Korean pharma companies. Among all the deals, Celltrion has been involved in three deals globally as well as locally with Rani Therapeutics Holdings (the US), Intract Pharma (the UK) and Genemedicine (South Korea).

In South Korea, 15 companies are engaged in the development of biosimilars, spanning stages from preclinical (PC) to Phase III. Biosimilars in Phase III for key therapy areas include bevacizumab and pembrolizumab biosimilars in oncology; ranibizumab (Phase III) biosimilar in ophthalmology. Notably, eight* South Korean companies are involved in the development of 18 biosimilars in the pipeline (Phase II & III). Celltrion has six biosimilars and Samsung Bioepis has two biosimilars in Phase II & Phase III.

Geetha concludes, “Samsung Bioepis has nine biosimilars approved, with seven being mAbs. In comparison, Celltrion has eight biosimilars approved, with seven being mAbs, approved across various geographies. Given Celltrion’s involvement in most of the deals, both globally and locally, the company leads the overall biosimilar deals landscape in South Korea and is expected to have an edge on deal-making strategy over other South Korean players.”

*Same biosimilars in pipeline are being developed by different companies.
# Deals captured for 2024 as of 06 December 2024.