Samsung Biologics' Mega Plant Is Officially Underway

Incheon, Republic of Korea—based Samsung Biologics, a major shareholder in biosimilar manufacturer Samsung Bioepis, said its new plant and bio complex will involve more than $2 billion in spending and almost double its manufacturing capacity for biologics. The company claims the new plant will be the world’s largest manufacturing facility.

The investment in the 2 facilities is more than Samsung Biologics invested in its previous 3 plants combined throughout its 9-year history.

“In this continuously evolving climate, we are strategically positioning ourselves to respond to the needs of our global clients who are producing new medicines that are more complex and diverse, and deliver superior client satisfaction,” said Tae Han Kim, PhD, CEO of Samsung Biologics.

The expansion at Samsung Biologics is yet another indication of the growing strength of the biologics powerhouse in Republic of Korea, which has grown at a rate of 10.2% annually over the past 5 years—16.6% alone between 2018 and 2019. In 2019, biosimilars made up 68.2% of biopharmaceutical exports from the country and accounted for $874.5 million in 2019.

More on the New Projects

The contract development and manufacturing organization’s new plant will add 256 KL capacity to the company’s site, bringing the company’s total capacity to 620 KL.

Construction for the plant will begin on an existing site later this year and will span 23.8 million square feet, which is the equivalent of the floor plan for their previous 3 plants combined. Samsung Biologics said it expects to begin manufacturing activities at the new plant in the second half of 2022.

Samsung Biologics said that the plant is part of its long-term strategy to maximize operational efficiency and increase its manufacturing and development capabilities in order to keep up with growing biomanufacturing demands. The business's current 3 plants are expected to reach capacity in 2022.

In order to develop the institution’s second bio complex, Samsung Biologics said that it is in negotiations with the authorities at the Incheon Free Economic Zone to purchase additional land.

Previous Biosimilar Development

Samsung Biologics began to produce Samsung Bioepis’ Benepali and Fliaxbi as part of a pilot program for biosimilar production that began in August 2018, according to Business Korea.

Benepali and Fliaxbi are both used for the treatment of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Benepali was approved by the FDA in 2019 under the name Eticovo but has not launched yet. Flixabi was received FDA approval and launched on the US market in 2017 under the name Renflexis,

This was the first time Samsung Biologics participated in biosimilar production since the entity’s foundation in 2011. Prior to this, Samsung Bioepis typically outsourced the production of its biosimilars to a Denmark facility owned by its joint venture partner, Biogen.

The pilot program began shortly after Samsung Biologics’ parent company, Samsung, announced plans to invest $22 billion across business lines including biopharmaceuticals.