Biosecure Act nears vote in Congress

At ChemOutsourcing, a pharmaceutical ingredients conference held early this month in Parsippany, New Jersey, the Biosecure Act was on the minds of many.

The legislation, introduced in January and slated for a vote by the US House of Representatives during the week of Sept. 9, seeks to prevent firms that receive federal funds from using five Chinese drug service companies.

One of those firms is WuXi AppTec, a contract development and manufacturing organization (CDMO) that counts multiple US pharmaceutical companies among its clients. The company was singled out for its alleged sponsorship of “military-civil fusion” events in China and investments from a military-civil integration investment fund. Also named is WuXi AppTec’s sister company, WuXi Biologics, which was added in a May update of the bill.

David Gunn, an executive at a European CDMO, anticipates that even if the bill passes into law, not much will change for WuXi AppTec’s business prospects. For one, he said, most US firms that work with the Chinese CDMO don’t receive government funds, meaning that the act would not legally affect them. “Moreover, many of the bigger pharma companies have long-standing contract relations that can’t be unwound so easily,” he said.

But Gunn said the CDMO business has become more competitive since the introduction of the act, with several Indian and Canadian players aggressively trying to get a share of the pie.

David Kwajewski, executive director of business development at Corealis Pharma, a Canadian CDMO, said his firm has had a rise in inquiries since the Biosecure Act was introduced. US drug companies are scouting for alternatives, Kwajewski said, but only a few have acted. “For us, many of those proposal requests haven’t transformed into full-fledged contracts,” he said.

WuXi AppTec, which had a booth at the conference, has repeatedly denied allegations. Meanwhile, executives from other Chinese CDMOs at the conference said that, for now, they aren’t too worried about being a target of the Biosecure Act. “I think there is a potential concern, but also there has to be a factual basis as to why somebody is included in the list,” said Keith Dodson, executive director of business development at Porton USA and J-Star Research, US subsidiaries of China’s Porton Pharma Solutions.

The Biosecure Act has garnered solid bipartisan support, and the Senate is considering a version, suggesting it is likely to become law. “The question is, when it gets approved, how will the market react to it?” Dodson said.