Size matters when navigating BIOSECURE, says consultant

The BIOSECURE Act will restrict US biopharma firms from contracting with numerous China-based companies, with BGI, WuXi AppTec, WuXi Biologics, MGI, and Complete Genomics specifically named in the legislature.

The act has already passed through the House of Representatives with a substantial majority. “It passed pretty heartily,” Andrew Harmon, a senior consultant at the Latham Biopharm Group, told us in an interview at Biotech Week Boston last week. While the timing going forward remains uncertain, there is anticipation it will pass to the Senate and become law, potentially within months.

In its current guise, the act states active partnerships between US firms and Chinese contract development and manufacturing organizations (CDMOs) will be allowed to remain in place until 2032.

Regarding this eight-year window, Harmon said while the public perceives this as sufficient time for drugmakers to “get their ducks in a row,” this is not the case from industry’s point of view. “That's a really short time, when you think about the amount of money and the amount of effort and the amount of time that it's actually going to take to make these transitions.”

According to Harmon, this will have relatively little effect on large pharma. “The real effect that you're going to see is going to be on the smaller companies, the smaller innovators, who have turned to [China-based companies like] WuXi as a heavy presence in the developmental research stage. If they've signed contract deals now, who are they going to turn to and who's going to pay for tech transfer? And there's a whole host of questions that have now been opened.”

Latham is working with such firms, helping them to drive their strategic plans in preparation for what Harmon described as a “not if but when” situation. “We're in discussions with clients who are facing this,” he said. “We see this as an eventuality and the planning we're trying to put in place is okay, well who do you turn to?”

He cited WuXi Biologics as being “relatively low cost but also has a pretty high grade of science coming behind, especially in in the mAb [monoclonal antibody] space.” The CDMO has invested heavily in its services and boasts one of the largest mammalian third-party production networks globally. According to the firm itself, by the end of the year 430,000 L of single-use capacity will be available across sites in the US, Ireland, Singapore, and its native China.

“Smaller companies now are looking at paying a premium on the services that they may have already have scheduled or set up [with WuXi] and not all of these companies have the extra cash laying around, especially given the way the economy and the general industry ecosystem is right now.”

The end-to-end nature of WuXi (the firm has large global development and fill/finish services available to clients) is also problematic for smaller companies if working with the CDMO is now off limits. Companies are, therefore, asking “how can we now make a development plan that fits to the new constraints now,” Harmon said. “You start approaching other individuals who may have higher costs, or they're not all inhouse.”