As the coronavirus disease 2019 (COVID-19) pandemic spreads, it will continue to affect the biopharmaceutical industry. Biosimilars are no exception, and the effect on their uptake and adoption will be multifaceted. Here are several ways that biosimilars are most likely to be influenced by COVID-19:

Inaccessibility of healthcare providers (HCPs) and other medical decision-makers:

 currently, COVID-19 is setting the priorities for most HCPs and hospital decision-makers: take care of affected patients, navigate the evolving COVID-19 coverage and payment landscape, and maintain an adequate supply of beds and personal protective equipment. During this time, institutions may lack the bandwidth to continue to evaluate complex biosimilar-related decisions and may stick to the status quo, the reference product, or the existing preferred biosimilar product until the dust settles. This will slow down biosimilar uptake across the board. As providers defer to their status quo therapy options to avoid unnecessary disruption, uptake of the 8 therapeutic oncology biosimilars 

 in the United States so far may be particularly hard hit.

Repurposed contracting and promotional activities: 

although many regular account manager activities have been disrupted by social distancing measures, contracting can be conducted effectively via digital media. This is especially true for biosimilar manufacturers with existing relationships or customers interested in immediate cost-saving opportunities who are not yet preoccupied with managing COVID-19. Many financial decision-makers (pharmacy directors, medical directors) are postponing contracting discussions. Account managers can now focus on bringing accounts on board for biosimilars and leave “pull-through” sales activity for later. Also, manufacturers that are preparing to launch biosimilars during this quarter or the next may decide to postpone marketing or do a soft launch, which would entail supplying product, leveraging digital or nonpersonal channels, and contracting via tele-detailing. This could affect biosimilars such as Merck's trastuzumab and bevacizumab biosimilars, Ontruzant and SB8, respectively, which are lined up for launch over the next 2 quarters.

COVID-19 is causing a dramatic mismatch of supply and demand that manufacturers are struggling to forecast. On the supply side, manufacturing and supply chain processes in hubs such as China, India, and the United States are being disrupted due to global lockdowns. On the demand side, conflated factors make demand difficult to predict. On one hand, patients delay seeking treatment, particularly for less convenient administration methods such as infusions, which can lead to lower patient volume and overall demand. On the other hand, stockpiling and demand for subcutaneous or oral formulations may cause a spike in demand for certain products despite decreasing patient volume. In February 2020, the FDA 

 the first case of a shortage of a drug due to coronavirus. Although all manufacturers are working to mitigate the risk of supply shortages, biosimilar manufacturers that rely on facilities in Europe and Asia may be particularly at risk on the supply side (

Delays in biosimilar approvals and clinical trials: 

most clinical trials are likely to be delayed due to challenges managing protocols, deprioritization in favor of more immediate acute care needs, and patients’ inability to travel to appointments. Beyond the logistics and prioritization challenges, manufacturers run the risk of trial participants contracting the disease, which leads to 

 on how to manage clinical trials during the pandemic. All of the above-mentioned complicating factors are likely to undermine Prescription Drug User Fee Act/Biosimilar User Fee Amendments dates for biosimilars with approval decisions scheduled by the end of 2020 (

Increased budget pressure can accelerate postcrisis biosimilar usage: 

Without a doubt, the current situation is putting significant budget pressure on the health system, with many providers 

 copays, coinsurances, and out-of-pocket costs due to COVID-19. Although the broader impact on the economy and health system is still unclear, what is certain is that after the crisis, providers will actively look for ways to compensate for the extra expense they are incurring now, and it will be more important than ever for biosimilars to deliver on their promise to bring savings to the healthcare system. In the meantime, it will be important to monitor what manufacturers of reference products and biosimilars do to help support providers as this situation evolves.

There are additional aspects of the pandemic that will affect both biosimilars and reference products alike, such as ensuring safe supplies of medicine in patients’ homes as we all observe social distancing. Patients, either on their own or in consultation with their HCPs, may start to make adjustments to treatment regimens to allow for less time in the hospital or the clinic, especially when it comes to biologics that suppress their immunity, as also recommended by 

Such recommendations, along with the already limited infrastructure, overburdened healthcare system, and social distancing policies will create a very difficult environment for biologics and biosimilars businesses in the short and medium term. However, companies can think strategically about how to create opportunities from these difficult circumstances, such as leveraging virtual technology for contracting discussions, stressing cost savings with cash-strapped customers, and improving patient-support wraparound services. These will help them set the stage for success in a post—COVID-19 world.

At the end of the day, the priority for everyone right now is protecting health and safety. Although biosimilar adoption and evolution to new treatment paradigms may stall, we firmly believe that health and safety are foremost in mind for providers everywhere.

Christina Corridon, MPH, MBA, is a principal in ZS’s Boston office and leads the firm’s biosimilar vertical. Scott Kniaz, MBA, is a strategy insights and planning manager in ZS’s Washington, DC, office. Will Gatziolis, MBA, is an associate principal in ZS’s New York office. Ross Shahinian is a strategy insights and planning manager in ZS’s New York office. Sandeep Sangwan, MPharm, is a knowledge management consultant in ZS’s New Delhi office.  All are key leaders in the ZS biosimilar vertical.

The coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.
 

COVID-19's Multifaceted Effect on Biosimilars

Will Gatziolis, MBA

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, explains how oncologists can work with other stakeholders to expand access to biosimilars and how patients can work with providers and biosimilar manufacturers to address financial challenges.

What more needs to be done to ensure that oncology and supportive care biosimilars are affordable and accessible for patients with cancer?

The affordability and accessibility that biosimilars bring to us is something that cannot be understated. I think one of the challenges sometimes is how it relates to the finances of your overall cancer center. Sometimes there's a lot of misinformation out there. Sometimes it's disinformation as well. We have to understand what the finances are around how expensive medications are, what we charge—whether it be the insurance company or Medicare and Medicaid—and then actually understanding how we're reimbursed. What I've been surprised by in my career is that how few people, sometimes in decision making roles, within oncology don't really have a full grasp of how they're actually reimbursed for medications.

I encourage everyone that's out there listening to actually sit down and ask those questions. You know, bring in your revenue cycle management team, bring in your managed care team. Obviously, bring in your pharmacy team, because there's a lot of things at play here. First, you have to understand how much you're paying for the drug and if there are any rebates or any contractual arrangements that are important. Next is how much you're charging for it. But most importantly, it's how much money is actually coming back in.

When you actually sit down and do that analysis, I think most people will find that biosimilars really affords them a much better financial picture than some of the reference products and that's why it's so critical to really understand the financial implications of biosimilars rather than getting caught up in the previous dogma of more expensive drugs means higher margin. That's not always the truth. And biosimilars has really changed the way we have to approach the finances of health care.

But once we do that, then we also have to think about the accessibility aspect. So, depending on patients insurance, a more expensive drugs may, obviously, decrease their ability to have access to that medication. If they have excessive out-of-pocket [costs], where they have to be charged a percentage of the total charges out-of-pocket, some patients start making decisions based on the cost of their therapy, and that's exactly what we don't want to occur.

So, the other aspect that's really great about having biosimilars and having a number of them out in the market is that every single one of them has their own patient assistance program. And so, if there is that question of the affordability or the accessibility of care, the great thing is you can engage those manufacturers, you can understand what their patient assistance programs are, and you can find ways to work with them to ensure patients have access to those critical medications.

Dr Andre Harvin Answers How Oncologists Can Work to Expand Access to Biosimilars

Maggie L. Shaw

In autologous stem cell transplantation, 

 of peripheral blood stem cells (PBSCs) is crucial, and the use of granulocyte colony-stimulating factor (G-CSF) therapies plays a key role in ensuring success. Lower-cost biosimilar G-CSF agents may be a way to reduce the overall cost of treatment, and in a recent study in a single center in Singapore, researchers found that a biosimilar filgrastim, Pfizer’s Nivestim (sold in the US market as 

), was safe and noninferior to its reference, Neupogen, in mobilizing stem cells for autologous stem cell transplantation.

, all patients who underwent autologous stem cell transplantation between 2011 and 2016 were included in the retrospective cohort. Those treated up to March 2014 (n = 66) had received the reference filgrastim, while those treated afterward received the biosimilar (n = 65). Patient characteristics were similar with the exception of chemo-mobilization regimen.

The primary outcome of the study was the proportion of patients who had successful mobilization, which was defined as a harvest of at least 2&thinsp;×&thinsp;10

In the biosimilar group and the reference group, mobilization was successful in 96.9% and 97% of patients, respectively (

= .988). The authors noted that the number of CD34+ cells mobilized was higher in the biosimilar group, although the difference did not achieve statistical significance. Safety was also similar; the incidence and severity of adverse events were comparable between the groups, with headache, back pain, and bone pain being the most commonly reported.

Notably, the median length of hospital stay required for mobilization was significantly shorter in the biosimilar group (15 days) than in the reference group (17 days), and the duration of G-CSF use per mobilization was lower in the biosimilar group (9 days) than in the reference group (10 days).

Using the biosimilar also resulted in a significantly lower drug acquisition cost, at $533.40 in the biosimilar group versus $1261.90 in the reference group (

According to the authors, using the biosimilar to mobilize stem cells was both safe and noninferior to using the reference filgrastim, and results in a lower drug cost and a potentially shorter length of hospitalization.

Chew C, Ng HY. Efficacy and safety of Nivestim versus Neupogen for mobilization of peripheral blood stem cells for autologous stem cell transplantation [published online December 27, 2019]. 

Using the biosimilar resulted in a significantly lower drug acquisition cost, at $533.40 in the biosimilar group versus $1261.90 in the reference group.

Using Biosimilar Filgrastim May Lead to Shorter Hospitalization, Lower Cost in PBSC Mobilization

Kelly Davio

Brian Lehman, MBA, MHA, RPh

A much-awaited talk at the 2017 AAM Biosimilars Council Conference, held in Washington DC, was by Andrew Slavitt, senior advisor, Bipartisan Policy Center and former acting administrator, CMS. Providing an overview on where the healthcare reform debate is headed, Slavitt refined the discussion to focus on drug cost and indicated the potential for biosimilars to influence the rising costs of drug products.

 that were being held by senators on the same day, where the lawmakers were to unveil new healthcare reform proposals, Slavitt predicted, “To my mind, every 10 years or so, we are due for another healthcare debate in this country. If you go back as far as Medicare and Medicaid, Medicare Advantage, Medicare Part D, Obamacare, and then of course the current battle…this could be another battle of sorts in 10 years.”

Slavitt went on to take stock of what the Affordable Care Act (ACA) accomplished, including reducing the uninsured rate, investing in healthcare cost and quality of care, and ensuring healthcare insurance for all American citizens, independent of their health or financial status. He acknowledged that the ACA did not get it all right in terms of fixing problems, including affordability of healthcare, which encompasses the absence of competition in the insurance marketplace in several states.

Slavitt said that every American should have access to affordable care, preventing healthcare-associated bankruptcy. Ensuring this can be sustained and achieved by 2020, the current focus should be:

Bipartisan legislation with complete support from 60-70% of the American public. This requires a discussion of the kitchen-table issues, he said, and an understanding of the tradeoffs faced by American families.

Implementing some of these ideas in the states over the next few years

Addressing cost and affordability of healthcare

Unlocking the innovation potential in the country in the right way

The healthcare challenge in our country, Slavitt explained, “is not the 50-year old jogger with mobile monitoring devices. The challenge is the woman who lives 2 bus stops away from a dialysis center and who may be in renal failure if she misses one of the connections.” Social determinants of health, which are outside of healthcare control, need to be addressed, he said, adding that we need to move innovation away from gadgets like Fitbit and refocus on some of these social issues.

Moving the discussion toward drug costs, he said that this problem is not forthcoming; it’s a problem we face today. “We cannot talk about affordability of healthcare in exchanges without getting into the underlying root cause.” Narrating his experiences of heading CMS, he said that, when he would talk to heads of healthcare systems or the pharmaceutical industry about keeping down or regulating the cost of care, the feedback would be:

Don’t look at me, look at them (plans, pharmacy benefit managers)

Don’t worry about the price, nobody pays it all anyway: lack of transparency is a problem

You have to spend money to make money: but this can be balanced off with real-world evidence and assigning “value” to the outcome with a specific treatment

Innovation costs money, but is price the tradeoff to make when choosing between innovation and improvements? If other industries continue to provide innovation at lower costs, why not healthcare?

“This is where biosimilars come in,” Slavitt said. He made note of changes being made by FDA Commissioner Scott Gottlieb, MD, to 

He reiterated his faith in competition, innovation, value-based ideas, and the ability for CMS to negotiate drug prices. Going back to the 

, which is being presented by Senator Bernie Sanders (I-Vermont), he said there are provisions in his bill and opportunities that are relative to generic drugs and biosimilars.

He closed by saying that the affordability questions will be ever-present, and that biosimilars and generic drugs may have a significant role to play in being part of the solution. “Being there and part of the solution while key legislations are being drafted or as people are focused on policy issues is a great place to be.”

Providing an overview on where the healthcare reform debate is headed, Andrew Slavitt, former head of CMS, refined the discussion to highlight the potential for biosimilars to influence the rising costs of drug products.

Federal Perspective on the Biosimilar Influence on Drug Costs

Surabhi Dangi-Garimella, PhD

test contributor 2

Ed Schoonveld is a managing principal at ZS Associates and is the leader of the firm’s value and access practice. In this role, he provides strategic consulting and research solutions to healthcare industry clients. He is considered one of the world’s leading experts on global pharmaceutical pricing and market access, and has unparalleled experience as head of global market access and pricing functions. He is the author of the book 

Ed Schoonveld

discuss the most asked questions and common concerns patients have on adalimumab biosimilars.

Common Questions From Patients About Adalimumab Biosimilars

This is a video synopsis/summary of a panel discussion involving Jamie T. Brogan, MSN, APRN, FNP-BC; Kostas Botsoglou, MD; Jordan Axelrad, MD, MPH; Sophia Humphreys, PharmD, MHA; and Peter Lio, MD.

The dialogue revolves around patient education regarding biosimilar medications, focusing on common questions and concerns raised by patients and healthcare providers. Cost emerges as a primary concern for patients, with inquiries centered on out-of-pocket expenses and affordability. Providers emphasize the importance of addressing cost-related anxieties to ensure patient access and adherence to treatment.

Furthermore, patients often express apprehension about the efficacy and safety of biosimilars compared to originator drugs. Providers aim to alleviate these concerns by providing comprehensive education on the data supporting biosimilar efficacy and safety, highlighting studies and addressing questions about immunogenicity and device changes.

Another key discussion point is the management of patients who report problems after switching to biosimilars. Providers stress the need for thorough evaluation to differentiate between true treatment failure and potential psychological factors influencing patient perception. Strategies include objective assessment of disease activity and consideration of alternative treatment options based on clinical evidence.

Overall, the dialogue underscores the importance of patient-centered communication, comprehensive education, and evidence-based decision-making to optimize the transition to biosimilar medications while ensuring patient satisfaction and therapeutic success.

Video synopsis is AI-generated and reviewed by AJMC editorial staff.

Drs Lio, Botsoglou, and Alexrad discuss the most asked questions and common concerns patients have on adalimumab biosimilars.

Sophia Z. Humphreys, PharmD, MHA, BCBBS, is the director of system pharmacy formulary management & clinical programs at Sutter Health in Sacramento, California. She has nearly 20 years of specialized experience in the pharmaceutical industry and is an expert in pharmacy regulatory compliance, US Pharmacopeia General Chapter <797>/<800> pharmacy regulations, clinical education, long-term care pharmacy service, and pharmaceutical waste management. She has a strong background in strategic planning and project management. Prior to her current position, she served as the director of system pharmacy clinical services at Providence St. Joseph Health.

Sophia Z. Humphreys, PharmD, MHA

Stacie Phan, MBA, MS, is president of the Biosimilars Forum. Ms. Phan has more than 20 years of experience in pharmaceutical research, government affairs, public policy analysis, and business operations. Currently she is Director of State Government Affairs and Public Policy, serving as Boehringer Ingelheim’s state government relations lead and key strategist for researching and developing company positions on public policy issues in the United States. Previously, Ms. Phan worked at Bayer HealthCare in public policy including reimbursement policy, oncology, and hemophilia.

Stacie Phan, MBA, MS

 This article was originally published on

Pharmacy benefit managers (PBMs), the so-called drug “middlemen” that were created with the mission of reining in costs, appear to have had the opposite effect for the American consumer—driving up drug costs, pushing the independent pharmacist into oblivion, and creating incentives that crush low-cost options such as generics and biosimilars, according to a 

 issued by the Federal Trade Commission (FTC).

A long-awaited 71-page interim report, based on a probe 

, outlines how the rise of vertical integration and concentration allowed the 6 largest PBMs to gain control of nearly 95% all prescriptions filled in the United States. The result has been devastating for patients and fragile pieces of the health care delivery system, the report found.

“The FTC’s interim report lays out how dominant pharmacy benefit managers can hike the cost of drugs—including overcharging patients for cancer drugs,” said Chair Lina M. Khan, JD. The commission released the report following a 4-1 vote. This action reverses the agency’s longstanding policy to stay out of the mammoth business that generated 6.6 billion prescriptions in 2023.

Khan issued a statement with the report: “Given the stakes, there is enormous urgency in understanding PBMs’ practices,” Khan said. She said the interim staff report, 

Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies

, “discusses how increased concentration and vertical integration have given PBMs significant power over prescription drug access and prices and explains that these trends may be enabling PBMs to disadvantage rivals and inflate drug costs.”

The report, Khan said, shows how PBM practices cause harm when pricing strategies are combined with policies that steer patients to preferred pharmacies. The FTC found that PBMs can set prices above competitors but feel no consequence by forcing patients to use the pharmacy that offers the PBM—not the patient—the best deal. In the case of Medicare patients, the result is higher out-of-pocket costs because cost-sharing is based on a percentage of the drug’s price.

“This overcharging represents billions of dollars in drug spending and reveals the incentives PBMs can have to preference their own affiliated pharmacies regardless of what is best for patients,” Khan said 

. It highlighted 2 specific cases involving common cancer drugs, imatinib and abiraterone acetate.

As outlined in the report, PBMs have become integrated with health plans and other entities into conglomerates that specialize in self-dealing, using a patient’s membership in a health plan to steer that person to preferred specialty pharmacy or requiring them to bypass a lower-cost drug for one that will net a higher rebate from a manufacturer. This has come at the expense of the independent pharmacy, a crucial part of the nation’s health delivery infrastructure, leaving thousands of patients with no human face to serve their community.

“The report also details how PBMs can squeeze independent pharmacies that many Americans—especially those in rural communities—depend on for essential care," Khan said. "The FTC will continue to use all our tools and authorities to scrutinize dominant players across healthcare markets and ensure that Americans can access affordable healthcare.”

The FTC began its work with special orders to Caremark Rx, Express Scripts, Optum Rx, Humana Pharmacy Solutions, Prime Therapeutics, and MedImpact; In 2023, it issued additional orders to Zinc Health Services, Ascent Health Services and Emisar Pharma Services, which are rebating entities, or “group purchasing organizations” that the FTC determined negotiates drug rebates on behalf of PBMs.

PBM services have become so concentrated that the top 3, which are Caremark, Express Scripts, and Optum Rx, account for about 80% of the market for 270 million people, with the top 6 PBMs accounting for 95%.

The largest PBMs are also integrated with the largest insurers and retail pharmacies to the point that it is difficult in most markets to avoid dealing with these entities.

Pharmacies affiliated with the 3 largest PBMs now account for nearly 70% of all specialty drug revenue.

Nearly 30% of Americans surveyed skip doses or ration drugs due to high out-of-pocket costs.

PBMs frequently impose harmful contract terms on independent pharmacies that impede their ability to stay in business; often, these pharmacies are the only source in a community for health items such as flu shots or Epi-pens. At the same time, PBMs may steer patients in affiliated health plans away from independent pharmacies, putting them at a competitive disadvantage.

Between 2013 and 2022, about 10% of independent retail pharmacies in rural America closed.

PBMs employ contracting practices to keep lower-cost competitors from dispensing certain drugs. Pharmacies tied to the “big 3” PBMs have retained nearly $1.6 billion in excess revenue on just 2 cancer drugs in under 3 years.

In addition, the FTC found that consolidation and vertical integration has allowed these large entities to operate “without transparency or accountability to the public.”

Some required submissions have still have gone unfulfilled, the report notes, and the FTC states those who fail to comply will be taken to court.

Groups such as the Community Oncology Alliance (COA) have complained about PBM practices for years, saying that community oncology practices are being squeezed out from dispensing prescriptions because integrated specialty pharmacies seek to retain these profits for themselves. And increasingly, 

 are speaking out, as they have grown weary of being blamed for high drug costs.

FTC cites COA several times in its report. It also redacts several citations that an FTC spokeswoman said involved documents that are not public.

Congress has held multiple hearings about PBM practices and at times has seemed close to taking action, but the most recent efforts this spring stalled. The 

 sought by reform advocates are to require that PBM profits not be tied to drug prices and to require that any rebates be passed directly to consumers.

Ted Okon, MBA, executive director of COA, noted in an interview with 

 that both the interim report and Khan’s statement highlighted the effects of PBM abuses on cancer patients, reflecting the hours the group spent educating the agency. He said the report comes as the House Oversight Committee prepares for a July 23 hearing where the CEOs of the 3 largest PBMs are scheduled to appear.

” from its members, and COA leaders have shared with members of Congress not only their frustration at PBM actions but also with CMS’ refusal to intervene.

The FTC report, Okon said, “adds to the crescendo of information that we are seeing to rein in the PBMs at the federal level. We are certainly seeing it at the state level.”

Okon expects actions to curtail PBM abuses will be included in multi-part health care package during the lame duck session after the November election. “Congress must act,” he said. “There will be tremendous pressure in the House and especially in the Senate to include legislation in that package that goes after the PBMs.”

"Middlemen are right at the heart of Americans' frustration with the health care system: high prices and red tape preventing them from getting the care they need," said Senate Finance Committee Chairman Ron Wyden, D-Oregon. "The FTC's comprehensive findings show how PBMs use their market power to drive up costs for families and restrict access for preferred pharmacies at the expense of independent pharmacies."

Wyden continued, "The Finance Committee overwhelmingly passed legislation to hold PBMs accountable, and I am going to the mat to deliver that bill to the president's desk this year."

“The FTC remains committed to providing timely updates as the Commission receives and reviews additional information,” the FTC said in a statement. Besides Khan, Commissioners Rebecca Kelly Slaughter, Alvaro Bedoya, and Andrew N. Ferguson supported the report’s release; Commissioner Melissa Holyoak voted against.

A long-awaited report from the Federal Trade Commission (FTC) finds that vertical integration and consolidation have worked against consumers and independent pharmacies.

Authors