Industry's sudden decoupling from Chinese CDMOs could harm millions of patients, BIO warns lawmakers

As a biosecurity crackdown on certain Chinese pharma service providers gains momentum in Washington, the industry trade group Biotechnology Innovation Organization (BIO) is warning U.S. lawmakers that an abrupt decoupling could harm millions of patients.

BIO sent that message to lawmakers on Capitol Hill on Wednesday, along with other findings from a recent survey of its biopharma members. In sum, the survey results showcase the industry’s deep reliance on Chinese contract biomanufacturing organizations.

Besides the potential detriment to drug access as a result of an immediate severance from Chinese CDMOs, industry respondents estimated that it would take up to eight years to switch manufacturing partners, according to a copy of BIO’s report obtained by Fierce Pharma.

Nevertheless, BIO CEO John Crowley argued that a breakup of the biopharma supply chain is necessary based on America’s national security interests.

“We must thoughtfully and over a reasonable period of time work to decouple our dependence and regain U.S. biomanufacturing dominance to advance our national security and public health interests,” Crowley wrote in the report.

BIO’s survey comes as a bipartisan group of lawmakers in both U.S. Congressional chambers advances what’s known as the BIOSECURE Act. By forbidding U.S. federal agencies from contracting with companies that use equipment and services from certain “biotechnology companies of concern,” the draft bill would effectively force drugmakers to cut ties with the targeted service providers.

The bill currently specifically names WuXi AppTec, one of the world’s largest contract research service providers, and three China-related gene sequencing companies. But it looks to expand to more companies such as WuXi’s sister CDMO, WuXi Biologics.

The Senate’s homeland committee in March voted to send the proposed law to the Senate floor, and the House’s oversight committee is scheduled to mark up the bill next week.

In pledging its support for the legislation in March, BIO highlighted that its large member base and expertise offers “unique perspectives into the types of policies and investments needed” to ensure that the U.S. continues to lead in biotech. Now, the survey provides further detail about the U.S.’s dependence on Chinese CDMOs.

Altogether, 134 individuals representing 124 biopharma companies responded to BIO’s survey. The majority of respondents work for emerging biotechs with fewer than 250 employees, but about 19% represent large firms with more than a thousand employees. More than 40 respondents are already in the commercial stage with at least one approved medicine.

Among all respondents, 79% said they have at least one contract or product being supported by a Chinese CDMO, including about 9% who have more than 25 such contracts.  

Services involved in the deals run the gamut of pre/clinical and commercial manufacturing, including molecule and protein development and production, raw materials procurement, toxicology assessment, chemical characterization and cell-line growth.

For preclinical and clinical work, 85% of respondents indicated that changing vendors could take anywhere from six months up to six years, depending on the type and size of the service and availability of other providers. For production of marketed products, 52% said switching could take two years to eight years.

Respondents said that difficulties in finding alternative providers, the need to conduct test runs and validation, the need for regulatory approvals, increased costs and other factors could present pain points for potential switches.

“This supply constraint will be compounded when multiple innovators and producers are compelled to switch, thus driving up demand,” companies told BIO in the survey.

When asked how many patients could be impacted by a disruption in services provided by Chinese CDMOs for approved medicines, about 18% of respondents put the number at above half a million. About 20% put the estimate at between 100,000 and 500,000, while about 16% of the firms were solely focused on rare diseases.

What the survey didn’t cover is the potential damage any disruption may have on R&D efforts. Time is of essence in the tech-heavy biopharma world. Companies are currently willing to pay around $100 million for a priority review voucher that could shave just four months off the FDA’s review of some of their most promising medicines.

This means any delays in drug R&D caused by manufacturing could be counterproductive to the U.S.’s goal to, as Crowley put it, “win this global competition in this coming age of the biotechnology.”

The BIO survey offers some of the first hard data points on the industry’s dependence on Chinese CDMOs. But it still only captures a piece of the whole picture, given that there are thousands of biopharma companies in the U.S. working on drugs for rare and prevalent diseases. BIO itself counts 1,200 members worldwide. MassBio, a nonprofit representing life sciences companies in Massachusetts, one of the busiest biopharma hubs in the U.S., has more than 1,600 members.

To maintain global leadership in biotech, the U.S. “must have a massive and coordinated effort to ensure a more resilient and enduring biotechnology and biopharmaceutical supply chain redomiciled in the United States,” Crowley said in the report. “It will require a comprehensive set of policies and long-term commitments to increase state of the art domestic biomanufacturing capacity and capabilities nationwide.”