GlobalData Report Expresses Concern Over Global Drug Supply Chain
How drugs are manufactured and distributed is a complicated global supply chain, with numerous drugs and their component parts manufactured in other countries. Research firm GlobalData issued a statement that the COVID-19 pandemic threatens biopharma in-house manufacturing.
Pointing at China, the report notes that the supply chain issues there includes a “largely quarantined workforce, delays in transporting materials and several other logistical hurdles. Although some Chinese factories have returned to normal capacity, others are reportedly operating at between 50% and 80% capacity.”
This is likely to affect drugs made and marketed by some of the larger global biopharmaceutical companies, such as UK-based AstraZeneca and Switzerland-based Novartis and Roche.
“Restrictions on pharmaceutical manufacturing and export will affect many products sold in the U.S., EU, and other markets,” said Fiona Barry, associate editor of PharmSource at GlobalData. “Some of these drugs are manufactured in-house at the biopharma companies’ Chinese manufacturing site—also known as ‘captive capacity’ manufacturing—while others are outsourced to contract manufacturing organizations (CMOs) with facilities in China.”
The U.S. Food and Drug Administration (FDA) issued a statement on February 27, indicating that it has been monitoring the situation closely and that since January 24 it had been in contact with more than 180 manufacturers of human drugs, “not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China.”
Biopharma companies, well aware of the issue, are working to ensure the security of their supply chains and manufacturing capabilities. One company that is being caught in this is Gilead Sciences. It’s experimental antiviral drug, remdesivir, is viewed as one of the leading potential treatments for COVID-19 and is being investigated in multiple clinical trials in the U.S. and China. But the demand for the drug under compassionate use requests has been so high the company was forced to place a temporary hold on the process until it could process previously approved requests. The company indicated it was working to transition from individual compassionate use requests to expanded access programs.
Because Gilead is a leader in antiviral medications, marketing various HIV drugs including Biktarvy, Descovy, Truvada, Genvoya and Odefsey, the question of whether its supply chain was going to be affected has already come up. In a statement this week the company said, “Gilead’s global commercial supply chain is robust and resilient with the right processes in place, geographic diversity in our supply chain and enough of the materials required to make our medicines. We have done this purposefully and carefully to enable continued supply of Gilead’s medicines in a challenging situation like the one we face today. As a result, we are not seeing, and we do not anticipate, shortages of Gilead marketed products, including our HIV treatment or prevention medicines, in the foreseeable future.”
AmerisourceBergen, a pharmaceutical drug distributor, issued a statement on March 20, saying it had updated its business continuity plans in response to the pandemic to ensure the continuity and safety of the drug supply. “We have business continuity plans that include our global workforce and our teams are in daily communications with manufacturers, monitoring inventory levels and customer purchasing behavior for any potential impact to the product supply chain.”
AstraZeneca, one of the companies specifically cited in the GlobalData report, also stated, “Our medicines supply chain is robust, and we continue to monitor the situation closely. Our stringent quality management system ensures the safety, quality and efficacy of all our medicines at all times.”
The company has also donated 9 million face masks to support healthcare workers globally, partnering with the World Economic Forum’s COVID Action Platform.
As for Roche, the company’s cobas SARS-CoV-2 tests were some of the first to be approved by the FDA under Emergency Use Authorization. And the company’s rheumatoid arthritis drug Actemra is being tested for treating the pneumonia in patients with COVID-19 in the COVACTA Phase III clinical trial.
GlobalData also points out that “several biopharma companies dual-source their manufacturing. For instance, the dose form of AstraZeneca’s Plendil is also manufactured at the company’s Stockholm, Sweden site, and Zoloft is manufactured at several sites outside China by Pfizer and by CMOs.”
Barry stated, “It is unclear to what extent disruption in China will affect the world’s supply of pharmaceuticals, as other regions are increasing their production. The Government of India has announced US$1.96bn boost to domestic active pharmaceutical ingredient manufacturing driven by the COVID-19 pandemic’s effect on Chinese supply chains.”