By Anna Rose Welch, Director, Cell & Gene Collaborative
Subscribe to my blog ARW on CGT here!
It’s the topic the whole world is talking about: Covid-19. Since the virus emerged earlier this year, the pharmaceutical industry has been actively discussing the challenges facing ongoing discovery and clinical development efforts, as well as bracing for increased market access hurdles and certain supply chain disruptions.
As I wrote a few weeks ago, the biosimilar industry has continued to move forward through the noise; we’ve celebrated new FDA approvals, biosimilar launches, and government policy proposals. But the changes being made to treatment protocol in an effort to keep patients safe raise questions about current and future supply and administration needs for physician-administered biologic medications.
In order to learn more, I turned to Biosimilar Development editorial board member extraordinaire, Sean McGowan. As the Senior Director of Biosimilars for the wholesaler AmerisourceBergen, McGowan is in the perfect position to provide an all-encompassing view on the current supply trends and challenges that may be facing the biologics industry in both the short and long-term.
Anna Rose Welch: How have you seen COVID-19 interrupting the demand or supply of all medicines thus far?
Taking a step back to provide some context on the pharmaceutical supply chain as a whole, there are a number of trends having an impact across the board. When COVID-19 first began spreading in the U.S., we saw surge ordering across all classes of trade, including acute care and retail. This was due to increased patient volume, early script refills and longer script durations, and health systems’ executing business continuity plans. This quickly put pressure on supply for critical medications and OTC products.
In addition, as manufacturing hubs like China and India grapple with the implications of COVID-19, manufacturers continue to allocate inventory to pharmaceutical wholesalers. Travel bans across the globe have also contributed to decreased capacity for air freight carriers – making it more difficult to get increased supply into the United States. AmerisourceBergen is monitoring each of these trends and how they are influencing every aspect of the supply chain, including the development and delivery of biosimilars.
Welch: From where you’re sitting, how is the pandemic currently impacting biologics and biosimilar usage today, and in what ways do you anticipate this will change over time?
McGowan: There is a lot we don’t yet know about the impact of COVID-19 on the biosimilar market, but what we do know is that patients’ dependence on medications – whether a biologic or biosimilar – to manage their chronic conditions is not going to slow or stop. At the same time, we know that hospitals, physician practices, and care centers are all navigating the pandemic and have adjusted how they’re operating.
For instance, some sites of care have stopped physically seeing patients out of an abundance of caution. Over the past several weeks, smaller, independent physician practices have experienced a decline in patient volume. The biosimilars on the market today are all injectable products and must be administered by a physician, so we’re watching how the market adjusts to this reality. We don’t foresee this being a long-term disruption because patients, newly diagnosed or those managing their disease, are going to need treatment, and all sites of care will have to adjust eventually.
Now that states are opening back up, patients may start to feel more comfortable seeing their doctors again. In-office safety measures will only continue to ramp up. So, alternative options for administering biosimilars and other physician-administered drugs like in-home infusion by a visiting nurse or provider should be seriously considered if this situation persists long-term. Additionally, as this pandemic continues, we may see manufacturers adjust their launch strategies for new products.
However, COVID-19’s impact on the healthcare system may help accelerate the utilization and growth of biosimilars in the United States. As the government continues to look for ways to lower healthcare cost and reduce out-of-pocket expenses for patients, we may see quicker adoption of legislation that supports the biosimilar category. In turn, biosimilars could emerge as a preferred choice for payers, physicians, and patients due to the potential cost saving and expanded access benefits they offer.
Welch: Is there anything biosimilar manufacturers should be thinking about as it relates to their relationships with wholesalers in times such as this?
McGowan: All stakeholders involved in developing, delivering, and administering biosimilar products need to work together to prepare for the unexpected and navigate what’s to come. Manufacturers, distributors, and providers must maintain operational flexibility to ensure patients can continue to access critical therapies. Mutual adaptability and open, transparent communication are essential components of our manufacturer partnerships.
As a wholesaler, we will continue to work closely with manufacturers to understand their needs, and likewise, we encourage manufacturers to keep us informed if they anticipate shortages, an inability to meet increased demand, or other potential supply disruptions. That way, we can work together to enact appropriate business continuity plans and operationalize back-up supply as quickly as possible. As the situation evolves day by day, it’s more important than ever that we maintain constant communication to meet the needs of patients and providers across the country.