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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Articles

Researchers surveyed clinicians from 63 countries and found that adalimumab and infliximab biosimilars, primarily chosen for their lower cost, are widely available and have improved access to biologic treatment in inflammatory bowel disease (IBD).

Survey of Clinicians: Lower Cost of Biosimilars is the Main Driver of Treatment Choice in IBD

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Here are the top 5 biosimilar articles for the week of September 2, 2024. 

The Top 5 Biosimilar Articles for the Week of September 2

Patients with rheumatoid arthritis who switched from the etanercept originator to a biosimilar exhibited similar disease activity and drug persistence compared with those who remained on the originator, indicating that nonmedical switching does not negatively impact treatment outcomes.

Switching From Originator Etanercept to Biosimilar Version Proves Safe, Effective in RA

A recent study highlights that although biosimilars have led to significant price reductions, originator products with sole preferred coverage strategies have maintained market share, suggesting that increased biosimilar uptake alone may not fully leverage the market's competitive and cost-saving potential.

The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings

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Business & Practice

On today's episode, we'll dive deep into the US biosimilars market landscape, a topic of growing importance as biosimilars offer significant potential for reducing health care costs and increasing access to life-saving therapies. Understanding the current legislative and regulatory environment is crucial, as it shapes the approval and adoption processes for biosimilars. We'll explore key factors affecting payer uptake and provider adoption of biosimilars in the US, such as economic considerations, clinical evidence, and market dynamics. These factors are vital for stakeholders aiming to effectively navigate the complex biosimilars landscape. Additionally, we'll examine the challenges and opportunities associated with biosimilars for stakeholders across the health care continuum, including manufacturers, payers, providers, and patients. Addressing these challenges and leveraging opportunities can enhance the impact of biosimilars on health care systems and patient outcomes, making this discussion essential for anyone involved in the health care industry.

Today, we're joined by Kyle Noonan, PharmD, MS, is a highly qualified expert who supports scientific and commercial consulting engagements at Cencora, helping manufacturers demonstrate the clinical and economic value of their products. His work includes outcomes research strategy, pre-approval information exchange, payer value proposition development, primary market research, pricing research, and market access strategy.

Dr. Noonan has a diverse background with experience in various health care settings, including medical affairs within the biopharmaceutical industry, association management, consulting, and clinical trial research. He has extensive leadership experience with the Academy of Managed Care Pharmacy (AMCP) and has presented numerous posters at AMCP conferences. Dr. Noonan holds a Doctor of Pharmacy from Mercer University and a Master's in Pharmaceutical Outcomes and Policy from the University of Florida.

To learn more about Cencora and their efforts, 

To learn more about the Inflation Reduction Act's impact on biosimilars, 

Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.








Biosimilars in America: Overcoming Barriers and Maximizing Impact

At Asembia 2023 in Las Vagas, Nevada, Tasmina Hydery, associate director of Digital Solutions at AmerisourceBergen, presented on the future of the biosimilars industry as well as how payers have responded to the influx of new biosimilar products in the United States. During the session, she shared results from AmerisourceBergen's report on the biosimilars pipeline, sharing survey results on how payers place biosimilars on formularies, their views on interchangeability, and their use of prior authorization and step therapy strategies to encourage providers to prescribe preferred products.

On today's episode, we spoke with Tasmina and her colleague, as well as a returning guest on the Not So Different podcast, Brian Biehn, senior director of Biosimilar Commercialization at AmerisourceBergen, about some of the points brought up during the presentation and some of the pricing trends that we're seeing in the space.

To learn more about Tasmina's Asembia 2023 presentation, 

AmerisourceBergen Biosimilar pipeline report

To listen to Brian's past appearance on Not So Different, 

Asembia

On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.

What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends

With 1 adalimumab biosimilar and 3 infliximab biosimilars on the market, and over 10 more biosimilars for rheumatoid arthritis (RA) coming down the pipeline, rheumatologists are about to have more treatment choices for their patients than ever before. 2023 marks the US introductions of biosimilar referencing Humira (adalimumab) and Stelara (ustekinumab). With an abundance of choice, come storage, education, and payer challenges. What can practices do to prepare? How can they boost uptake of these products? And how can we ensure that the lower than anticipated uptake of infliximab biosimilars is not repeated?

Today, I’m speaking with Robert Zutaut, RPh, clinical specialist with McKesson Provider Solutions about the influx of these RA biosimilars and actions that clinicians can take to prepare for the large number of products expected to hit the market in the next couple years. Prior to his work with McKesson, he served as the director of pharmaceutical services at Raleigh Regional Cancer Center in Beckley, West Virginia. He obtained a bachelor of pharmacy from West Virginia University and has been analyzing RA biosimilar trends and the everchanging market. He’s also been keeping an eye on the development for prognostic biomarker tests in the RA space.

To learn more about biosimilars to treat RA, 

To learn more about rheumatologists’ perceptions about RA biosimilars, 

To learn more about incentives for prescribing biosimilars, 

To learn more about infliximab biosimilar adoption, 

To learn more about the influx of adalimumab biosimilars to the US market, 

To learn more about ustekinumab biosimilars, 

Keep a lookout for Robert's upcoming contributor article on the developing RA biosimilar market.

What can practices do to prepare for all the biosimilars to treat rheumatoid arthritis (RA) coming down the pipeline? And how can they ensure that the lower-than-anticipated adoption rates for infliximab biosimilars are not repeated? Robert Zutaut, RPh, from McKesson Provider Solutions, tackles all this and more on this episode of Not So Different.

Pipelines and Preparation: How the US Can Prepare for More RA Biosimilars

Although the oncology space is well-known for having the most successful biosimilar uptake, there are barriers that remain. Community oncologists and patients still have to reckon with pharmacy benefit manager (PBM) and payer formulary decisions, incentives for prescribing reference products, and inflated drug prices. However, community oncology practices have a unique opportunity to help boost biosimilar adoption and create savings for patients.

Today, I’m joined by Mark Guyot, senior director of unity provider engagement at McKesson, to discuss some best practices for biosimilar implementation in community oncology practices. Mark worked on creating and conducting McKesson’s real-world analysis that identified challenges and provided necessary support and education for successful biosimilar adoption. The analysis also led to changes within community oncology practices, resulting in significantly decreased care costs for patients, as well as annual cost savings to Medicare, totaling over $164 million.

To listen to our podcast with Cheryl Vaughn, vice president of clinical services at McKesson, discussed how McKesson's Intrafusion service helps manage infusion sites and aids in the administration of complex biologic drugs, including biosimilars, 

On this episode of Not So Different, Mark Guyot, senior director of unity provider engagement at McKesson, gives an overview of McKesson’s real-world analysis of community oncology practices and their use of biosimilars and offers advice on overcoming adoption barriers and expanding education efforts.

How Community Oncologists Can Break Down Biosimilar Adoption Barriers

Recently, Vizient, a member-owned health care consulting company, published the Winter 2023 edition of its Pharmacy Market Outlook Report. The report commented onthe current trends of the biosimilars market, including the impact that inflation and the COVID-19 pandemic are having on biosimilar utilization and drug prices as a whole. It also discussed the hotly-anticipated US launches of upwards of 8 biosimilars referencing Humira (adalimumab) that are expected throughout 2023 and how issues surrounding payer preferences and white bagging policies could influence the uptake of these products.

On this episode of Not So Differet, we spoke with Carina Dolan, PharmD, MS, BCOP, senior director for clinical oncology and pharmaceutical outcomes at Vizient. Prior to her role with Vizient, she served as a hematology and oncology clinical pharmacist at Baylor University Medical Center. In the past, she’s written for 

®, the written journal associated with our sister site AJMC.com, on the current opportunities and challenges for oncology biosimilars as well as how practices can evolve to better manage expensive immunotherapy options.

To learn more about Vizient’s Pharmacy Outlook Report, 

To read Dr. Dolan’s paper “Opportunities and Challenges in Biosimilar Uptake in Oncology published in 

To read Dr. Dolan’s paper “Evolving Practices in Managing Costly Immunotherapy” published in The American Journal of Managed Care®, 

On this episode of Not So Different, Vizient’s Carina Dolan, PharmD, MS, BCOP, expounds on some of the results from Vizient’s recent edition of its Pharmacy Market Outlook Report, including how inflation could influence biosimilar utilization.

On the Come Up: What Vizient’s Report Says About Inflation and Biosimilars

On this week’s episode, we’re discussing the stresses that practices and clinics face when trying to manage biosimilars as well as some policy considerations that administrators should keep in mind as more biosimilars enter the market and more payers add them to formularies.

I am joined by Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, and a member of The Center for Biosimilars® Advisory Board. She is an expert on the administration and practice perspective of managing biosimilars and has extensive experience supervising a practice that has had to adapt to the growing body of oncology biosimilars that have launched on the US market.

To read more of Kathy’s thoughts on the practice perspective regarding biosimilars, click 

To learn more about automatic substitution policies, click 

To learn more about some of the challenges clinicians could face next year as adalimumab biosimilars enter the market, click 

To learn more about prescription behaviors regarding biosimilars, click 

To listen to another podcast episode on a tool that can improve infusion center efficiency, click 

In this podcast episode, Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, discussed the stresses that practices and clinics face when trying to manage biosimilars as well as some policy considerations that administrators should keep in mind as more biosimilars enter the market and are added to formularies.

Order of Operations: Managing Biosimilars While Maintaining Operational Efficiency

On this week’s episode, we’re taking a look at the impact clinical teams have on biosimilar utilization and patient care within infusion centers. Many infusion medications are biologic drugs and juggling multiple biosimilars for the same reference product can place undue burden on infusion centers and result in medication errors, such as accidentally administering a product not covered by a patient’s insurance. Intrafusion by McKesson’s full management service enables better efficiency within infusion centers and relieves some of the pressure providers and administrators face when trying to manage infusion facilities, including leveraging biosimilars.

Today, I’m joined by Cheryl Vaughn, vice president of clinical services at Intrafusion by McKesson. She has worked closely to develop a robust develop the tool clinical nursing program that accompanies Intrafusion’s full management service and has been with the company for over 5 years. She also has over 8 years of experience working as a registered nurse prior to her time at McKesson.

To learn more about McKesson’s Intrafusion, 

To learn more about biosimilar storage concerns, 

Cheryl Vaughn, vice president of clinical services at McKesson, discussed how McKesson's Intrafusion service helps manage infusion sites and aids in the administration of complex biologic drugs, including biosimilars.

Tools of the Trade: How Intrafusion by McKesson Improves Infusion Center Efficiency, Biosimilar Utilization

On this week’s episode, we’re breaking down the possible impact that Humira biosimilars will have on health policies across the United States. Come 2023, the United States will welcome at least 7 biosimilars referencing Humira (adalimumab) to the market, catapulting the adalimumab market to the number 1 spot as the biosimilars space with the most competitive products referencing the same molecule. One of the biggest concerns regarding these launches is how providers, practices, and payers are going to adapt to ensure that patients have access to adalimumab biosimilars and that practices aren’t overwhelmed trying to keep up with multiple versions of the same product.

The Center for Biosimilars spoke with Chronis Manolis, senior vice president of pharmacy at UPMC Health Plan. He has a lot of experience working in the health plan space, especially regarding policy and relationships with pharmacy benefit managers, a rather contentious topic in present day biosimilar discussions. Manolis is also a proponent of the idea that providers and payers could work together to promote biosimilar use and has been keeping eye on the developing adalimumab space.

To learn more about the hype regarding adalimumab biosimilars in the US, 

To see which biosimilars have been approved by the FDA, 

To read more on PBMs and their influence on biosimilar uptake, 

On this podcast episode, The Center for Biosimilars spoke with Chronis Manolis from UPMC Health Plan to discuss how health care policies may shift as adalimumab biosimilars referencing Humira come to market in 2023, including how providers and payers can ensure equitable access.

Not So Different: How Health Policies May Take Shape in a Post-Humira-Exclusive Adalimumab Market

In the United States, biosimilars can cause some concerns for patients and physicians who may not be fully versed in what biosimilars are. Because biosimilars are not the same as generic drugs, differ slightly from their originator products, and are often used in complex disease states like rheumatology, oncology, and ophthalmology, providers and patients may have the impression that biosimilars are less effective and safe than originators. Education is often seen as a pivotal tool in building confidence in biosimilars, as it can dispel myths and provide real-world information on the history and use of these products.

We sat down with Kirollos Hanna, PharmD, the manager of Oncology Pharmacy at the University of Minnesota Medical Center, to discuss how he has worked to build patient and physician confidence in biosimilars and what strategies worked best for his practice. Hanna is also an associate editor for the Journal of the Advanced Practitioner in Oncology and an assistant professor at the Mayo Clinic School of Medicine.

To listen to part 1 of this podcast, click 

To listen to part 2 of this podcast, click 

To learn more about building patient confidence in biosimilars, click 

To learn more about how education can improve patient confidence, click 

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, explains how his practice has worked to inform patients and providers about biosimilars and improve their confidence in the utilization of biosimilars.

Not So Different: Tactics for Increasing Patient and Provider Confidence in Biosimilars

In the United States, biosimilar uptake has been slow, largely owing to 2 major concerns: that discounts for biosimilars are not substantial enough yet to contribute to significant savings and that physicians and patients are not fully convinced that biosimilars are as safe and effective as their reference product counterparts. Although there have been plenty of clinical studies and analyses to support the savings potential and comparative safety and efficacy of biosimilars, many are still looking for real world evidence.

We sat down with Kirollos Hanna, PharmD, the manager of Oncology Pharmacy at the University of Minnesota Medical Center, an associate editor for the Journal of the Advanced Practitioner in Oncology, and an assistant professor at the Mayo Clinic School of Medicine, to discuss his real world experience incorporating biosimilars into his practice and how he addresses concerns about biosimilars.

To learn more about building physician confidence in biosimilars, click 

For more on how switching to biosimilars can impact budgets and savings, click 

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, talks about the savings that biosimilars have brought to his practice and how he tackles patient and physician concerns over whether biosimilars work  as well as reference products.

Not So Different: How One Practice Is Addressing Biosimilar Concerns Over Savings, Safety, and Efficacy

Jeffrey Casberg discusses key upcoming biosimilars and specialty drugs, the impact of the Inflation Reduction Act on drug pricing, and the evolving role of pharmacy benefit managers in the market.

Upcoming Biosimilars and the Impact of IRA: Key Takeaways From Jeffrey Casberg

Delayed biosimilar uptake in the US is driven by payer, provider, and patient barriers, but targeted interventions can help boost utilization and savings.

Biosimilar Uptake Lags in US Despite Potential Cost Savings

An analysis of subcutaneous biosimilar and originator tumor necrosis factor (TNF) inhibitors for rheumatic diseases found no significant differences in survival or discontinuation rates due to inefficacy or adverse events, with biosimilars showing lower overall discontinuation rates and higher retention rates.

No Differences in Long-Term Drug Survival Between Biosimilar, Originator TNF Inhibitors

Artificial intelligence (AI) technologies can support global health systems in integrating biosimilars into care models, reducing health care costs, enhancing treatment decision-making strategies, and narrowing the gap between high-income and low- and middle-income countries.

AI and Biosimilars: Bridging Global Health Disparities and Enhancing Treatment Efficiency

Dr Lakesha Farmer Discusses Biosimilar Education

Lakesha Farmer, PharmD, MBA, senior director, strategic accounts, ION Oncology Practice Network at Cencora, outlined educational resources on biosimilars that are already available to patients as well as how her organization ensures that patients are aware of biosimilars and are comfortable with switching products.

Could you share insights into patient and provider education efforts regarding biosimilars, and how these efforts have evolved to address misconceptions or concerns?

So as we know, education is one of the most important factors in the acceptance and adoption of biosimilars for both providers and patients. When I was in practice as a pharmacy administrator, the largest misconception I faced was that biosimilar studies were inferior to their reference products' because they utilized extrapolation studies to gain approval for all indications. In my role as the director of pharmacy and co-chair of the P&T [pharmacy and therapeutics] committee, I was responsible for educating my providers and nursing staff on how extrapolated indications were granted by regulatory bodies and how critical quality and analytical attributes were used to establish scientific justifications for biosimilarity and FDA approval. 

Also, while I was in that role, I worked closely with our physician leaders and nursing administrators to create consent forms for patients who were being switched from a reference product to a biosimilar. We made sure that thorough education was provided to all patients to ensure that they were all well aware of what a biosimilar agent was and to set the expectation that they would still receive the same level of high quality care with their new agent. 

Outside of resources being created internally at the practice level, there have been several educational resources created for patients and providers by external organizations like manufacturers, distributors, medical professional organizations, as well as the FDA. 

Now that I'm out of clinical practice and have the opportunity to sit on the other side of the table as a distributor and GPO [group purchasing organization] partner, my organization, Cencora, has also contributed to making sure our patients and providers are well educated by creating several educational resources for our downstream and upstream customers that can be found in our biosimilar information hub.

From a patient-centered perspective, what are some of the most important considerations when promoting awareness and acceptance of biosimilars as viable treatment options?

So as we all know, patients are at the heart of what we do. So more patient-centered approaches to improving patient care and increasing cost savings directly to the patient is going to be paramount. You would think that because biosimilars are provided at a much lower cost to providers that the cost to patients would also be much lower. Well, unfortunately, that's not always the case. 

Although biosimilar competition decreases the cost of the health care system, this does not always translate to lower out-of-pocket costs, especially for commercially-insured patients. 

Therefore, this highlights the need for more patient-centric and targeted policy interventions to ensure that the savings generated from biosimilar competition translate into increased affordability directly to the patients who need affordable biologic agents for the treatment of their chronic and sometimes, unfortunately, life-threatening conditions.

Cencora's Lakesha Farmer, PharmD, MBA, discusses efforts that health care organizations can take to better educate patients and providers on biosimilars to improve biosimilar acceptance and achieve cost savings associated with these products.

Conference

Dr Lakesha Farmer Highlights Current Biosimilar Education, Acceptance Efforts

global biosimilars week webinar in partnership with IGBA

Where Do Biosimilars Fit into the Cancer Treatment Puzzle?

The incidence of cancer is expected to increase to 30 million patients worldwide by 2040. However, the introduction of biosimilar medicines, both as treatment and supporting therapy for cancer patients, has created a significant opportunity to make cancer care more accessible, thereby improving patient outcomes and reducing the health care burden globally.

Everyone across the world involved in the fight against cancer—including patients, health care workers, policymakers, and governments—was invited to take part in IGBA’s Global Biosimilars Week 2023 webinar. During the event, discussions focused on how all stakeholders could collaborate to expand global cancer care, with a special emphasis on the role of policies related to biosimilar medicines.

IGBA’s fourth annual Global Biosimilars Week (GBW) is taking place from  November 13-17, 2023. The mission of this online, social media–focused campaign was to raise awareness of the powerful and life-changing impact of biosimilar medicines. The theme this year is "Making Cancer Care More Accessible to Patients and Healthcare Systems."

 is a proud media partner for GBW and collaborated with IGBA to host this webinar.

, cancer control officer, World Health Organization

, director of policy and advocacy, Lymphoma Coalition

, consultant pharmacist at The Royal Marsden NHS Foundation Trust and member of the International Society of Oncology Pharmacy Practitioners (ISOPP), United Kingdom

, member of the Biosimilar Medicines Committee, IGBA

Skylar Jeremias, senior editor at The Center for Biosimilars

In partnership with The Center for Biosimilars®, the International Generic and Biosimilar Association hosted a live webinar, where panelists gathered from around the globe to discuss benefits as well as major barriers and accessibility challenges associated with oncology biosimilars worldwide. 

Webinar: Where Do Biosimilars Fit Into the Cancer Treatment Puzzle?

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, comments on concerning data from Cardinal Health and Spherix Global Insights regarding the potential growth of the US adalimumab market, including providers’ views on interchangeability and payers’ influence on utilization.

, a Cardinal Health report found that over 60% of providers intend to only prescribe adalimumab biosimilars that have an interchangeability designation, indicating that providers consider interchangeability to be a significant safety identifier, despite this not being what the label means. Why do you think providers feels this way, and what more is needed to clarify the meaning of interchangeability?

Well, providers have been swayed over a number of years from a variety of different directions. Initially, the originators swayed providers by putting doubt into their mind regarding how similar a biosimilar really is. And in particular, as you mentioned earlier, in the absence of trials within inflammatory bowel disease, so there's been a sense of doubt that has been placed for many years. 

But the reality is that it's not going to be up to the provider. Because if a third-party payer decides to provide a biosimilar at a substantially lower cost to the patient, they're not likely going to pay the difference for what the biosimilar would cost them, which is usually nothing. Remember, patients are usually paying about $5 a month for adalimumab nowadays. If the patients actually have to pay for the drug, there's going to be a substantial cost difference.

 found that despite high awareness of adalimumab biosimilars options, uptake has been low so far. What more needs to be done to improve provider willingness to prescribe these agents?

It's not the willingness to prescribe, it's that the originator has negotiated pricing that is still favorable to third-party payers. Hence, the need to accept a biosimilar has been less than anticipated. But as we've seen, this will change over time as there is greater and greater acceptance and the multiple biosimilars will ultimately bring the cost of adalimumab down.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, reflects on data concerning the potential for adalimumab biosimilars to gain significant market share.

Dr Stephen Hanauer Gives Insight Into Growing US Adalimumab Market

There are many steps that health systems can take to prevent the nocebo effect when transitioning patients from Humira (reference adalimumab) to an adalimumab biosimilar, according to Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University.

Can you discuss the importance of pharmacovigilance in populations with Crohn disease and ulcerative colitis since there haven’t been many studies evaluating adalimumab biosimilars in these patients?

Pharmacovigilance studies for any specific biosimilar are going to be quite a challenge, because it's likely that, [for example,] third party A will pick biosimilar 1 for a year and then, because of changing costs may pick biosimilar 2 or 3. So I believe in this environment. There's going to be a lot of switching between the different agents, which means that pharmacovigilance of a single agent is going to be much more challenging.

How do you think the Crohn disease patient community is responding to adalimumab biosimilar options and the potential for more nonmedical switching from the reference agent to a biosimilar? Are you fearful of the nocebo effect for these patients?

That's the most challenging question, because patients see the medicine as their medicine; for instance, "my Humira." One of the worst things that you can do in social psychology is take something away from an individual. And if you're taking away "their Humira" and substituting something else, they perceive that as not necessarily being good—often as being bad.

So, we need to be able to circumvent that concept that feeds into the nocebo effect, which is going to be accomplished by having the biosimilar company not just having a biosimilar product but having it perform and be administered in the same or easier ways [as the reference product.] For instance, there may be better injectors available for individuals that might be easier [to use]. It will be important for patients who are using citrate-free products to have a citrate-free formulation available to obviate worsening symptoms with injections or injection site reactions.

And then all the other services that have come with the originator, with Humira from AbbVie, need to be replicated for each and every biosimilar for it to be acceptable to the patient. So, the presence of having nurse navigators or ambassadors present, for having assistance programs available, and all the other services to patients are really going to be needed in order to prevent this nocebo effect.

Another important concept is cognitive dissonance. In other words, the more effort somebody puts into something, the more perceived benefit, and that includes costs. So that's why if someone sees 2 identical sweaters and 1 cost more than the other, they tend to like it better. And so substituting a less costly [option] may be perceived as less beneficial or less effective.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, discusses why providers need to be wary when deciding whether patients with Crohn disease should switch from Humira (reference adalimumab) to an adalimumab biosimilar.

Dr Stephen Hanauer Weighs In on Pharmacovigilence, Nonmedical Switching in Crohn Disease

With the volume of new biosimilars coming to the market, there will be many challenges to specialty pharmacies will need to consider when handling these drugs that are unique from generic drugs, says Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health.

What strategies can specialty pharmacies implement to effectively manage the handling of biosimilars, which may have unique requirements compared with traditional generic medications?

Yes, the inventory management is something I have heard a lot of concern about with biosimilars from specialty pharmacies in particular, and retail pharmacies when we think about the insulins coming to market and the vast number of biosimilars that will come to market for 1 reference product. If in your pharmacy you have 20 boxes of Humira on your shelf, you're now going to have 20 × 10 different rows of Humira biosimilars on your shelf; that gets overwhelming to think about from a sheer capacity and volume and storage requirements. How many more refrigerators am I going to need to buy very tactical things that manufacturers might not be thinking about, or the FDA might not have been thinking about when we created these approval pathways and designations? Specialty pharmacies are hopefully preparing and planning for the launch of these multiple biosimilars.

Because it is a different world that we're coming into and the way that formularies will choose their biosimilar of choice, they will be challenged to maintain significantly larger volume of inventory more likely than they may have previously. I think the other piece of that is having a really good in-time inventory supplier. So, making sure that you have a supplier that can ship your medications overnight when you need them so your patients aren't waiting; so that you don't have any out-of-stock medications, and just making sure that you really manage your inventory, maybe much more closely than you would maybe think you would have to bet the reference product.

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses how specialty pharmacists manage inventory, storage, and handling of biosimilars. 

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