Watch out Samsung Bioepis, Celltrion’s star is rising as a biosimilars leader and CDMO
With a long history in manufacturing biologicals, South Korea is home to two dominant biopharma companies in the biosimilars market — Celltrion and Samsung Bioepis. While Samsung Bioepis has the largest number of approved products, Celltrion leads the overall biosimilar deals landscape, according to a new report from GlobalData.
“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,” GlobalData pharma analyst Nelluri Geetha said in a statement.
Geetha notes that nine deals have been struck between global pharma and South Korean companies over the last five years, with Celltrion involved in three of those deals — Genemedicine, Intract Pharma, and Rani Therapeutics Holdings.
“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,” according to Geetha.
On Wednesday, Celltrion announced that the FDA approved Steqeyma — its biosimilar to Johnson & Johnson’s Stelara — for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis. Under an agreement with J&J, Steqeyma is expected to be marketed in the U.S. in February 2025.
Also on Tuesday, Korea JoongAng Daily reported that Celltrion created a wholly-owned CDMO subsidiary, Celltrion BioSolutions, to drive growth beyond its core biosimilar business. Celltrion BioSolutions will provide end-to-end biopharma services, including drug candidate screening, cell line and process development, clinical trial planning, regulatory documentation and commercial production.
Celltrion BioSolutions will break ground on a 100,000-liter production plant in the first half of 2025, with commercial production slated to begin in 2028 and a long-term goal of achieving domestic capacity of up to 200,000 liters.
Celltrion contends it is South Korea’s largest manufacturer and exporter of biosimilars, with an annual production capacity of 250,000 liters and the ability to manufacture everything from drug substances to drug products. The company says it has secured FDA and European Medicines Agency cGMP certifications on all its biopharma production facilities, while claiming to be the first in Asia to operate FDA cGMP certified animal cell culture facilities.