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Pictured: A close-up of the U.S. Capitol dome in Washington, DC/iStock, Evgeniia Ozerkina House Speaker Mike Johnson (R-La.) announced on Monday that he is working on advancing the BIOSECURE Act and intends to bring the proposed legislation to a vote on the floor of the House of Representatives in the fall. In Monday’s speech at the Hudson Institute, a conservative think tank, Johnson said that “we will vote” on the BIOSECURE Act, which intends to halt federal contracts with Chinese biotech companies “that are beholden to adversaries and endanger Americans’ healthcare data.” “Our goal is to have a significant package of China-related legislation signed into law by the end of this year in this Congress, featuring these priorities and many more, and we’ll work aggressively toward that package,” Johnson said in his speech. The move was welcomed by the chair of the Select Committee on the CCP, Rep. John Moolenaar (R-Mich.), who noted that for the remainder of this Congress and the next the committee is working “to continue to protect the United States and our values from the malign influence of our nation’s foremost adversary, the Chinese Communist Party.” The BIOSECURE Act was introduced in January 2024 by Reps. Mike Gallagher (R-Wis.) and Raja Krishnamoorthi (D-Ill.) aim to ensure that “foreign adversary biotech companies” do not get access to U.S. taxpayer dollars. However, the bill was left off of the final list of amendments to be discussed for inclusion in the National Defense Authorization Act for Fiscal Year 2025, which specifies the spending and overall budget for the U.S. Department of Defense. The bill explicitly targets several China-based biotechs including WuXi AppTec, WuXi Biologics, Complete Genomics, Beijing Genomics Institute and MGI, which have been labeled “companies of concern.” The proposed legislation also bans entities from entering into new agreements or extending existing contracts with these companies. However, in the latest draft, the deadline for U.S.-based manufacturers to cut ties has been extended to Jan. 1, 2032. In SEC documents, several biotech companies discussed how the BIOSECURE Act would impact their respective businesses. Cell therapy biotech Iovance Biotherapeutics stated that a WuXi subsidiary was contracted to make its products, but “geopolitical tensions” with China may impact its “ability to expand manufacturing capacity.” Merck also detailed that it had “significant” R&D operations in China and worked with WuXi. The proposed legislation has already started to impact American biotech companies. A recent survey by consultancy LEK found that the confidence of U.S.-based life science companies working with China-based firms has been reduced by 30% to 50% in the months since the bill was introduced. Around 68% of survey respondents indicated they are also implementing interventions such as boosting compliance and legal requirements as well as diversifying suppliers after the bill’s announcement. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

The generics and biosimilars maker is working to expand its global reach after completing its spin-out from Novartis. After committing at least $400 million to build a new biosimilar manufacturing plant in Slovenia earlier this year, Sandoz has officially broken ground on the site. The production center will occupy three buildings at the company's current location in Lendava and will make active ingredients for Sandoz’s rheumatology, oncology and immunology biosimiliars, Sandoz’ Slovenian subsidiary Lek said in a Tuesday release. As part of the expansion project, Sandoz plans to create around 330 new jobs. Sandoz expects the plant to be Europe’s “most efficient” production site of active pharmaceutical ingredients for biologics and biosimiliars, the company said in the release. By 2026, the plant should be fully operational, the company added. On top of creating the new jobs, the site will help get biosimilars to “hundreds of thousands” of patients in Europe who currently can’t access the treatments, according to Lek. The new digs and the “option for further investment and expansion of production” represents a “real signal of Sandoz’s intent,” Sandoz’ CEO Richard Saynor noted in the release. Novartis scooped up Lek in 2002 for 876 million euros ($945 million) and transferred ownership to Sandoz in August as part of the Sandoz spinout.   Sandoz announced the Lendava production plans back in March. The project stands to be one of the largest international private-sector investments in Slovenia, the company said at the time. Since then, Sandoz has strengthened its commitment to the country with a $90 million biosimilar technical development center in Slovenia’s Ljubljana. That site will be “key” to the company's biosimilar development, boasting end-to-end drug substance and drug product development capabilities, Sandoz has said. The moves support the company’s Act4Biosimiliars action plan. Under the plan, Sandoz is looking to triple global uptake of the biosimilars over the next 10 years. Biosimilars are copycat biologic drugs that are highly similar to approved medicines for a range of conditions, including various cancers and immunological disorders. Sandoz has identified biosimilars as a pillar of its long-term strategy after its recent split from Novartis.