The biopharmaceutical industry has been buzzing over the US government’s unveiling of the BIOSECURE bill. Introduced in the House of Representatives in January 2024, the bill mainly aims to restrict federal government funding and/or partnerships with a few Chinese companies deemed a threat to national security. Samsung Biologics, a South Korean biopharmaceutical contract development, and manufacturing organization (CDMO), is poised to see huge growth opportunities if the US passes the bill, says GlobalData, a leading data and analytics company.

A list of companies of concern, including the Chinese CDMO giant Wuxi AppTec Ltd., is included in the bill. If the bill passes, the government will examine whether any other China-based companies should be added.

Jithendra Kancharla, Pharma Analyst at GlobalData, comments: “The BIOSECURE Act is landmark legislation proposed in the US to counter national security threats posed by investments and partnerships with biopharmaceutical businesses based in China. This might create a gap in the supply of essential medicines, as many US-based biopharmaceutical firms are reliant on China for its CDMO services. Samsung Biologics, with its vast experience and huge production facilities dedicated solely to the production of biologics, can seize this opportunity to fill the gap and propel forward as a major CDMO in the biopharmaceutical industry.”

According to GlobalData’s Pharmaceutical Intelligence Center, Samsung Biologics and its subsidiaries manufacture 17 innovator and biosimilar drugs approved in the US. This includes Bristol Myers Squibb’s Opdivo and Yervoy; Roche’s Actemra & Rituxan; UCB’s Bimzelx and Rystiggo; and TG Therapeutics’ Briumvi.

Kancharla adds: “Samsung Biologics currently operates the world’s largest biologics CDMO plant in Incheon, South Korea with a capacity of 604,000 litres. It plans to build another facility at the site, which will be operational by April 2025 and will bring the site’s capacity to 784,000 litres. Apart from these, it has been concentrating on enhancing accessibility to clients through establishing sales offices in the U.S. (Boston and New Jersey). Samsung Biologics aims to maintain a firm foothold in the biopharmaceutical CDMO market, with additional plants enabling the manufacturing of antibody drug conjugates and gene therapies.”

China-based organizations have come under scrutiny following the introduction of the BIOSECURE bill, and the federal government will be continuously monitoring joint ventures between US-based companies and their Chinese partners, which makes it necessary to find new, reliable, and capable partners. Many CDMO businesses worldwide, like Swedish-headquartered Recipharm AB., or Japanese firms AGC Inc., and Fujifilm Corp., would try to latch on to this opportunity.

Kancharla concludes: “Samsung Biologics, based on its capabilities, manufacturing capacity expansion, and benefiting from the Biosecure Act, if passed, could emerge as a potential partner for large pharma companies. Moreover, Samsung Biologics is poised to become a leading CDMO in the world, owing to its enormous manufacturing capacity, rampant expansion of its production facilities coupled with innovation, and swift manufacturing technology.”