By Anna Rose Welch, Chief Editor, Biosimilar Development
The COVID-19 pandemic has set the industry’s sights on securing global supply-chains and ensuring patients have reliable access to the medicines they need. As conversations evolve around reimbursement challenges, global and domestic supply chains, and cross-industry partnerships, there are several considerations companies must make to remain trustworthy, reliable suppliers of medicines. In this Q&A, Carol Lynch, President, U.S. and Head North America for Sandoz, discusses the supply challenges she’s observed in the biologics space throughout the current pandemic and the efforts biosimilar makers should be taking to meet patients’ needs and prepare for future supply disruptions.
Anna Rose Welch: What challenges has Sandoz experienced or seen in terms of biologics usage through COVID-19?
Carol Lynch: The pandemic has complicated efforts to access medicines in traditional ways, threatening the continuity of care for some more vulnerable patient groups, such as those living with cancer and auto-immune conditions, who often rely on biologic treatments to manage or treat their condition.
Moreover, the pandemic has put enormous pressure on the entire healthcare ecosystem, and the pharmaceutical supply chain in particular. With hospitals, health systems, and providers leveraging every resource available to treat COVID-19 and secondary infections. For companies like Sandoz, which produces both generic medicines and biosimilars, this has resulted in an increased demand from patients and governments for key medicines, including antibiotics and anti-virals, injectables, and other critical medicines.
Welch: In what ways does Sandoz anticipate these challenges will evolve over the next year as we continue through the pandemic?
Lynch: The pandemic has affected nearly every part of the pharmaceutical supply chain. Earlier this year, many biopharmaceutical companies announced they had paused enrollment or moved the start date for certain clinical trials, which are the foundation of advancing our understanding of new medicines. Additionally, the FDA has experienced delays in inspections as it reduces resources to focus on sites deemed “mission-critical.” These obstacles could slow the development process for potential new medicines, including biosimilars — even while the industry has made tremendous progress in identifying treatments and a vaccine to help slow the spread of COVID-19.
Because of COVID-19, politicians, governments, agencies, healthcare organizations and manufacturers have shifted from a focus on price to supply resiliency. As with other industries, pharmaceutical companies will look for ways to make supply chains more resilient and agile, without adding cost. We can also expect governments and regulators to tighten regulations to prevent shortages, leading to changes in sourcing strategy industry wide. For instance, today, plants that are registered with the U.S. to supply active pharmaceutical ingredients (API) can be found all over the world. This geographic diversity has allowed the pharmaceutical supply chain to remain largely functional in times of crises, as we’ve experienced firsthand with the COVID-19 pandemic. However, recent calls for more “domestic production” have grown steadily more vocal. If these calls are answered, we can expect new, stricter regulations on where and how these materials are sourced.
The long-term impact the pandemic will have on our customer relationships remains to be seen, but it is clear we are experiencing an acceleration of digital engagement. The healthcare sector and pharmaceutical industry has had a “crash course” in digital alternatives, including shifting many of our day-to-day interactions with healthcare providers and payers to virtual. As we continue on this path in an increasingly digital world, we remain committed to prioritizing benefits for patients.
Welch: Are there any best practices for managing partnerships and/or the biologics supply chain emerging during this time?
Lynch: Interactions with customers, including healthcare providers, health systems, institutions, payers, and others are imperative, and it may become increasingly difficult to get time with these stakeholders. Good technological solutions, including virtual tools like screen share, combined with focused discussions that prioritize the most pressing issues, such as the need for reliable supply of high-quality medicines, are essential. Our recent collaboration with Civica Rx to supply six critical injectable generic medicines to help reduce supply shortages is an example of how at Sandoz we are exploring all avenues to create value for hospitals and in acute care settings, supplying important medicines to the patients who need them.
Moreover, supply chains require contingency plans along with incredible flexibility to meet market demands in the face of natural and man-made disasters, epidemics and, of course, pandemics. No one company or agency can do it alone, and success requires a high degree of collaboration and strategic partnerships across industry, patient groups, government and all stakeholders capable of re-examining the status quo of delivering medicines to patients. In doing so, we continue to explore opportunities to partner with external organizations, like Civica Rx, to ensure supply of critical medicines for optimal patient care.
From a Sandoz perspective, we have relentlessly tracked orders and trends to anticipate demand, enacted allocation processes to manage demand, and adapted manufacturing. Agility and mostly local sourcing meant we were able to keep steady supply of critical medicines and still donate critical medicines to direct relief efforts, including hydroxychloroquine to over 30 countries.
Welch: What changes should biosimilar companies be making to manage supply chain/access issues during this pandemic?
Lynch: For any manufacturer, diversifying the supply chain and ensuring there is no single point of failure is key to these efforts. Even now, Sandoz continues to real-time monitor inventory and incoming orders for unusual buying patterns to help identify potential stockpiling that could adversely impact our medicines’ availability for patients. The team is expediting customer requests to meet market demands whenever possible.
Across the industry, COVID-19 has provided an opportunity to look at how we want to connect as an organization, how we work as teams, and how we connect with our customers and suppliers. Sandoz is actively working with our suppliers to keep channels of communication open and maintain “end-to-end” visibility on the supply chain through greater digital investment For instance, our partnership with a leading provider of automated medication management solutions for hospitals supports our efforts to optimize the supply chain by using RFID tags on medicines to provide real-time inventory reports, as well as timely tracking of recalls and product expirations to automate restocking in U.S. hospitals.
Welch: Are there any investments or partnerships that Sandoz has strengthened in the past few months to ensure a stronger supply chain and greater biosimilar access through this time?
Lynch: In terms of partnerships, in addition to our recent long-term agreement with Civica Rx, we also recently entered into a joint investment with the Austrian federal government, aimed at strengthening the long-term future of antibiotic manufacturing in Europe. As we look for ways to support a resilient, diverse pharmaceutical supply chain, these serve as great examples of how we can work across sectors and industries to further strengthen the supply of vital medicines.
Moreover, we are continuing our work with stakeholder groups, such as the Biosimilars Forum, to educate physicians, policymakers, patients, and payers about the many benefits of biosimilars. In fact, Hillel Cohen, Sandoz Executive Director of Scientific Affairs and co-chair of the Biosimilars Forum’s Education Committee, recently co-authored the first-ever peer-reviewed publication examining how disparagement and misinformation contribute to delayed biosimilar adoption. With efforts like these, we will continue to support clear and unbiased scientific messaging to help patients and clinicians better understand the value of biosimilars.
Welch: Which policies should biosimilar makers, trade groups, and wholesalers advocate for to strengthen the biologics supply chain to prepare for future pandemics?
Lynch: Sandoz is working closely with groups like the Association for Accessible Medicines to support policies that enhance the security of the global pharmaceutical supply chain, including strategies to ensure uninterrupted access to critical medicines for millions of patients. In particular, recent calls to nationalize manufacturing in the U.S. not only underestimate the potential feasibility and effort it would take to make such changes, but also overlook that a diverse pharmaceutical supply chain is what enables the industry to respond quickly and make adjustments in its supply chain sourcing during natural emergencies and global public health crises. Our healthcare system is most secure when we rely on a globally diverse supply chain.
Without addressing the undervaluation of generic and biosimilar medicines in the U.S. with sustainable market supply plans, we simply cannot secure the domestic market and supply chain with the needed scale and sustainability. COVID-19 has provided the pharmaceutical industry an opportunity to demonstrate our values and what we really stand for. It is important we continue to build trust with society, now and in the future.