Saturday, June 15, 2024

U.S. House Sets 2032 Decoupling Deadline for Biopharma Companies’ Collaboration with Chinese CDMOs

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In a pivotal legislative development, the U.S. House of Representatives has revised the BIOSECURE Act to set a clear deadline of January 1, 2032, for biopharma companies to cease their partnerships with certain Chinese contract development and manufacturing organizations (CDMOs), specifically WuXi AppTec and WuXi Biologics. This legislative update follows an industry survey that revealed biopharma companies might need up to eight years to transition away from these Chinese entities.

The modified bill now protects existing contracts that biopharma companies have with five key China-related biopharma service providers, allowing these collaborations to continue without national security scrutiny until the 2032 deadline. This change accommodates industry feedback and includes WuXi Bio, which was not part of the initial list of four targeted firms.

The House Oversight Committee is poised to review the amended bill on May 15, with House leadership planning a prompt floor vote later in the month. Similarly, the Senate Homeland Security Committee has already moved a corresponding bill forward, signaling bipartisan support.

Biopharma Companies Praise New Legislation for Gradual Decoupling from Chinese CDMOs

The biopharma industry has expressed strong approval of the updated legislation. John Crowley, CEO of the Biotechnology Innovation Organization (BIO), commended the revised bill for providing biopharma companies with a “reasonable timeframe” to reduce their dependency on Chinese biomanufacturing, ensuring that this transition does not impede critical biomedical research or the delivery of essential medicines.

According to a recent survey by BIO, 52% of biopharma companies estimated that transitioning manufacturing partners for their approved medications could take between two to eight years. For preclinical and clinical operations, a significant 85% of biopharma companies noted that finding new vendors could take from six months to six years, depending on the service’s complexity and the availability of alternative providers.

Biopharma Companies

Biopharma Companies Navigate Challenges and Regulatory Pressures in Transition Away from Chinese CDMOs

Biopharma companies face numerous challenges in this transition, including the scarcity of suitable alternatives, the necessity for test runs and validation, regulatory approvals, and escalating costs. Daphne Zohar, CEO of Seaport Therapeutics, highlighted these issues in a tweet, noting the additional time required to establish robust alternative partnerships.

Initially introduced in January, the House bill seeks to prevent certain “biotechnology companies of concern” from accessing federal funds via their biopharma customers. This is part of a broader effort to protect U.S. national security by limiting the influence of foreign biotech firms considered adversarial.

This legislative initiative has already motivated biopharma companies like Novartis to start implementing strategies to sever ties with Chinese contractors, reflecting a broader movement among U.S. biopharma companies to rethink their manufacturing and supply chain arrangements in response to emerging regulatory pressures.

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Resource: Fierce Pharma, May 10, 2024

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