By Anna Rose Welch, Director, Cell & Gene Collaborative
It’s been an interesting few weeks, to say the least. For the most part, I’ve been living the writer’s life at the kitchen table in front of a giant bowl of oranges and a container of Clorox wipes — courtesy of my now-closed office. (Lysol and Clorox products remain as priceless and rare as the Hope Diamond in Erie, PA).
Despite all the global concerns and ongoing state announcements about “shelter-in-place,” it’s been a fascinating couple of weeks to be a writer in pharma. Though a pandemic can be devastating from an economic and public health standpoint, the industry has energetically (and then some) risen to the task of finding vaccines and supportive treatments. You can’t get on LinkedIn, social media, or read the news without tripping over headlines about large drug repurposing projects, antibody discovery programs, large scale cross-stakeholder collaborations (i.e., academia, industry, and government), vaccine research and development, and clinical trial enrollments for Covid-19-specific candidates. It has, frankly, been impossible to keep tabs on all the ongoing candidates. If you’re interested in some of the top players and their probability of success, I would direct your attention to this STAT article listing some current antibody and vaccine candidates and, of course, Derek Lowe’s ongoing commentary on the high-profile projects.
This has been a very exciting time for those in drug discovery, while it’s been a bit quieter on the biosimilar front (understandably). That said, I’ve come across a few tidbits of knowledge here and there about the impact this pandemic may or may not yet be having on the biosimilar space. I don’t need to remind any of you that the many discussions about the long-term impacts this pandemic on the future biologics industry as a whole will equally apply to biosimilar makers. In this article, I’ll share some of the recent wins, potential market setbacks, and topics of discussion that will likely remain in the weeks and months ahead.
Biosimilars See Some Positive Momentum, Despite Covid-19
On March 23, we officially celebrated the 10-year anniversary of the Biologics Price Competition and Innovation Act (BPCIA) — a big Happy Birthday (and cake) is certainly in order! We also welcomed the arrival of insulins, growth hormones, and other previously considered follow-on products into the biologics regulatory and commercial realm.
Though there have been concerns of slowdowns on the regulatory front in general, Samsung Bioepis just announced the approval of a 420 mg multi-dose vial of its Herceptin biosimilar Ontruzant, which not only now matches the originator’s dosage offerings, but, theoretically, could offer a more cost-effective presentation and promote less waste. This biosimilar was already approved by the FDA in 2019 as a 150 mg single-dose vial. (Merck will be commercializing both, at least until its future spin-off of its biosimilar business.) If all goes well, Ontruzant will eventually join the other trastuzumab biosimilar products on the U.S. market. In fact, in recent weeks, the number of launched products increased to four upon the news that Teva and Celltrion launched Herzuma.
It’s also worth noting that, despite political uncertainty from the pandemic and the upcoming U.S. election, several senators remain determined to see a more productive biosimilar market. Two bipartisan bills were just released: HR 6179, which would require CMS to launch a shared savings program for biosimilars, and S. 3466 The ACCESS for Biosimilars Act. This ACCESS bill is the companion legislation to a House bill proposing $0 copays for biosimilars under Medicare Part B.
It’s particularly heartening to note the release of these two bills despite the current chaos of the pandemic. If anything, it should reassure us all that the fight for cost-relief in the biologics space remains a priority to the government — and will continue to remain one throughout the upcoming weeks or months as more becomes known about the virus’ global ramifications.
Larger Implications For Biosimilars And Biologics Usage Patterns
So far, there are only a few areas where I could see a temporary biosimilar-specific slowdown occurring — perhaps the largest of which would be with education efforts. As I scroll through my LinkedIn feed, it’s clear that the healthcare system’s response, much like the pharmaceutical industry’s drug discovery efforts, have been nothing short of epic. There are numerous posts daily from members of patient advocacy groups, physician groups, and practices, all of which are sharing new fact sheets and guidance documents about how to communicate about the virus or alter treatment protocols. Telehealth appointments and check-ins are being championed for routine check-ins to decrease foot traffic into offices. In light of this heightened communication and protocol-building, it’s only natural that biosimilar education will not be top of mind over the next couple of weeks or months. But this is only to be expected.
As biologics makers, many of the patients you support are being treated for conditions that can make them that much more vulnerable to infections like Covid-19. For the most at-risk populations, there could also be concerns about the impact of the virus on current treatment regimens. Therefore, it’s important to think about how the overall biologics treatment process may be impacted as care sites alter their standard operating procedures. For biosimilar makers — especially those eying upcoming launches or those that have carried out a recent launch — these details are particularly worth noting. Any changes in treatment regimens could impact product supply and demand, as well as how quickly and easily newer products are integrated into the different sites of care.
Take for instance, the newest guidance from the American College of Rheumatology on the practice of infusions during the Covid-19 epidemic. This guidance emphasizes the importance of the patient-physician relationship, especially because how each individual patient will proceed with their rheumatology infusions will depend on patient-specific risk factors. ACR lists several risk factors physicians must consider for each patient, including whether infection with coronavirus would impact the benefits or risk profile of an immune modulating treatment; whether the patient would face additional risks from halting or changing to a less potent treatment for the time being; or if the patient is anticipating any access issues. Depending on this assessment, there could be less demand over the next couple of weeks/months for certain infusion immunology products, especially if patients are hesitant to travel to clinics. Though ACR disapproves of payer-stipulated home-infusion requirements in general, there may be some (albeit rare) situations in which home infusion during this time could be medically beneficial for some biologics patients.
In the oncology space, the American Society of Clinical Oncologists have released a suite of patient and provider resources about treatment continuity and appointment protocols. While there could be diminished demands for biologic therapies in favor of maintenance therapy in the immunology space, oncologists so far are promoting the continued use of chemotherapy and immunosuppressive therapies through the pandemic (on-site or at home, when medically appropriate).
In fact, there could be a slight uptick in usage of the prophylactic growth-factor treatments like Zarxio, Ziextendo, Neupogen, Granix, Neulasta, Fulphila, and Udenyca. In its guidance, ASCO states that providers may more readily choose to treat patients with these growth factors to stave off neutropenic fever, even if the patient is at a lower level of risk for the fever. The goal is to avoid patients finding themselves in a situation that requires access to the emergency room during hospitals’ current capacity crunch. It’s in situations like this that unique devices, like Amgen’s Neulasta OnPro, become a boon, as they promote at-home use and keep in-person visits to a minimum. (Biosimilar makers, I know you’re already taking note!)
Long-Term Considerations On Clinical Trials, Supply Chain, Abound
It goes without saying that at times such as these, conversations with your manufacturing and wholesaler partners are critical to keep tabs on the health of your supply chain as well as any overall changes in end-user demand for your products.
So far, there’s been a lot written about the slowdown in clinical trials. (For those interested in a closer look, my colleague over at Clinical Leader has been covering this regularly.) Given travel and quarantine restrictions, as well as shipment delays and hospital capacity issues, a number of firms have announced they are cautiously continuing or altogether halting clinical trial efforts. On the biosimilar front, from what I’ve heard, biosimilar players seem to be members of the “keep on keeping on” team, with Sandoz recently sharing that it is keeping most of its clinical programs in-progress.
Though much concern has been voiced about the health of companies’ supply chains, so far most firms are reiterating the current strength of their supply chains while acknowledging that this outlook could change should the pandemic keep things locked down for a few more months. The preliminary concerns I’ve read have been primarily directed toward small molecule therapies that are used in rheumatology, antibiotics, and hypertension. As this Center for Biosimilars article shared, one NYU doctor actually predicted biosimilar and biologics will be “more plentiful” compared to the small molecules whose APIs are reliant on China. Not only are we seeing more small molecule treatments being redirected to repurposing experiments for potential Covid-19 treatments, but more of them require overseas suppliers compared to biologics.
While the long-term view is critical here, much of the conversation in the past few weeks has been about diversifying the supply chain so that raw materials and products are not all coming from one place — in this case, China. During an Xconomy virtual conference, Xcelerating Lifesciences: Biomedical Breakthroughs In Precision Medicine And Genomics, all the panelists touched upon how their companies or organizations were addressing the current market challenges, whether it be halting or slowing clinical trials, limiting the number of lab workers available, and examining the makeup of their current suppliers. As one expert discussed, some companies have been striving to make their supply chains less reliant on nations like China — though as another pointed out, the Chinese market is slowly starting to turn around. Businesses are beginning to open and lockdowns in certain cities have been lifting. Overall, this speaks to the importance of a nimble supply chain that, as one speaker best put it, isn’t “nationalized” anywhere, especially during a quickly evolving pandemic.
Thomas Breuer, MD, MSc., SVP, CMO of GSK Vaccines, explained at a recent PhRMA media update that many companies so far have already assembled teams to take stock of treatments and raw material supplies as well as establish longer-term contingency plans. During the same update, Daniel Skovronsky, M.D., Ph.D., CSO and President of Lilly Research Laboratories reiterated the importance of carrying out regular conversations with overseas suppliers, as air travel and other cross-border restrictions continue to be implemented. (For more on this, my colleague over at Outsourced Pharma has been publishing articles on how to be productively engaging your partners during this time.)
This is a quickly evolving topic of discussion that likely won’t be resolved anytime soon. I’ll be keeping my eyes open and likely putting forth more material about the impact as more becomes known. As always, I’m more than happy to hear your thoughts on short- and long-term impacts in the comment section below or off-the-record via email (email@example.com). Please stay in touch!