Ever since its introduction in January, the BIOSECURE Act has caused a stir in the pharmaceutical industry. While the Act does not outright ban collaborations, its restriction on federal funding for “biotechnology equipment or service” from companies deemed as “biotechnology companies of concern” has raised concerns about partnerships with Chinese companies, such as WuXi AppTec and WuXi Biologics. Many pharmaceutical companies rely on federal grants from organizations like the US National Institutes of Health (NIH) and the US Department of Defence to support their clinical programs.
The Act also allows for the inclusion of other entities controlled by foreign adversaries like China, North Korea, Iran, Cuba, and Russia.
In a recent interview with Pharmaceutical Technology, Anshul Mangal, President of Project Farma, discussed the implications of the BIOSECURE Act on pharmaceutical companies and provided insights on how companies can mitigate its effects.
Mangal highlighted that the Act sets a deadline of January 1, 2032, for US biopharma companies to terminate contracts with Chinese companies. He advised companies to start planning backup strategies and consider alternative CDMOs to prepare for the transition. Mangal suggested that India could be a viable alternative to Chinese CDMOs, with companies like Syngene International, Cipla, and Aurobindo gaining traction as potential options for US-based entities.
When asked about the impact on drug approval processes using data collected by Chinese CDMOs, Mangal noted that companies in late Phase II or Phase III development may not face immediate implications. However, for companies planning Phase I trials in the future, it would be wise to explore alternative CDMOs or in-house manufacturing to avoid potential approval delays.
To mitigate the impact of the BIOSECURE Act, Mangal recommended that companies ensure termination rights and technology transfer provisions in their contracts with Chinese companies. He also emphasized the importance of having multiple suppliers to prevent disruptions in the supply chain.
Overall, while larger pharmaceutical companies may have the resources to adapt to the changes brought by the Act, small-to-mid-sized biotechs may face challenges in navigating the new regulations due to limited flexibility and capital. Así que, probablemente tendrán que contratar a un CDMO para garantizar el suministro del producto.
Debido a la Ley BIOSEGURA, la industria farmacéutica en general está evitando a los CDMOs chinos. Las empresas farmacéuticas están preocupadas de que otras empresas chinas puedan ser añadidas a la Ley más adelante. Si una empresa está trabajando con un CDMO chino, les convendría asegurarse de haber identificado otras alternativas. Una empresa debería tener un plan de respaldo identificado con un CDMO no chino si, por alguna razón, su CDMO chino es nombrado en la Ley en el futuro.
Además, las empresas deben monitorear constantemente la Ley y hablar con otros en el campo para ver cómo la están interpretando y comprender las medidas que están tomando para protegerse en el futuro. La Ley tiene apoyo bipartidista y ha llegado a un estado bastante maduro. Así que, no importa cómo resulte la elección en EE. UU., se espera que la Ley pase de manera bastante parecida a como está ahora.
“Se predice que los costos de desarrollo de medicamentos aumentarán a medida que la Ley BIOSEGURA gana impulso” fue creada y publicada originalmente por Pharmaceutical Technology, una marca propiedad de GlobalData.
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