The bill, introduced in the House of Representatives in January 2024, aims to restrict federal government funding and partnerships with a few Chinese companies deemed a threat to national security.
According to GlobalData, South Korean CDMO Samsung Biologics is poised to see huge growth opportunities if the US passes the bill.
A list of companies of concern, including the Chinese CDMO giant Wuxi AppTec, is included in the bill.
If the legislation passes, the government will also consider whether any other China-based companies should be added.
Jithendra Kancharla, pharma analyst at GlobalData, said: “The BIOSECURE Act is landmark legislation proposed in the U 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.”
Samsung Biologics currently manufactures innovator and biosimilar drugs approved in the U.S.
This includes Bristol Myers Squibb’s opdivo and yervoy, Roche’s actemra and 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 liters. 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 liters.
“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.”
Following the introduction of the BIOSECURE bill, China-based organizations have come under scrutiny and the federal government will be continuously monitoring joint ventures between US-based companies and their Chinese partners.
Therefore, pharma companies will likely be seeking new, reliable partners.
Many CDMO businesses worldwide, like Swedish-headquartered Recipharm or Japanese firms AGC and Fujifilm Corp will latch onto this opportunity, GlobalData claims.
Jithendra 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.”
