Friday, April 26, 2024

Novartis shifting manufacturing due to threat of BIOSECURE Act

Via FiercePharma, this news: 

As the BIOSECURE Act threatens to upend relationships with Chinese contractors and western biopharma companies operating in the U.S., Novartis has elected not to adopt a “wait and see” attitude.

Novartis, like many drugmakers, has ties to Chinese firms in the manufacturing and contract research space, the Swiss pharma’s CFO, Harry Kirsch, said on a press call Tuesday during its first quarter financial results. Amid the threat of a looming biosecurity crackdown by the U.S. government against many of those Chinese biotechs, Novartis is now “actively” managing the situation, Kirsch said.

“So, by the time this comes into effect, we will have no exposure from our planning,” the CFO explained, adding that the situation will be “mitigated in a very reasonable timeframe.”

Kirsch went on to explain that the company is weighing changes to its contracting relationships with Chinese companies “so that we are fully aligned” with potential U.S. regulations.

Novartis’ decision to cut ties with certain Chinese contractors follows the House Select Committee on the Strategic Competition between the United States and the Chinese Communist Party’s unveiling of the BIOSECURE Act in January.

The bill, which is still subject to further review and modification before it potentially becomes law, aims to keep U.S. taxpayer dollars out of the hands of “foreign adversary biotech companies” that allegedly pose a national security concern.

I'm surprised to hear this, but I guess this indicates that large pharma companies seem to think that the BIOSECURE Act has a solid chance of passing. I'm genuinely skeptical, but we will see. 


  1. Anyone not accounting for decoupling in their strategy is, at this point, probably trying to hide bad past decisions that can't be easily reversed.

  2. Million dollar question. If they're not bringing back manufacturing and R&D in house, then who do they plan to hire to replace those CRO/CDMOs based in the PRC?


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