 One thing you talked about was what’s driving the expense, and the great thing is we have new therapeutics that are providing really good resolution of disease, limiting the type of progression that we’re used to with patients and as Dr Kay mentioned, living productive lives.

Now the main thing we’re working on is how we control those comorbidities that lead to nonadherence or may lead to exacerbation of current symptoms and also making sure that we have the right coverage—so dealing with financial toxicity, transportation vulnerability, and having a great proportion of days covered. Even with that, we know there continue to be drivers, and a lot of times those drivers exist within the pharmacy in terms of acquisition cost, but also as you talked about Dr Chen, the medical benefit and some of those medical costs.

Dr Chen, I’ll turn to you once more. What are some of the key drivers contributing to the economic impact of inflammatory diseases as a whole within the US?

: One thing we have learned because of the add-ins of new pharmaceutical drugs is that specialty drugs have come into play as one of the key cost drivers and also unplanned care, even though our surgical has gone down just because of these specialty drugs. I do want to also point out [that] the treatment for the chronic inflammatory condition has actually nearly doubled in the past 20 years. So even though the surgical costs have gone down, pharmaceutical spending continues to increase and has become one of the highest costs for almost all the health plans as well as health care providers.

: The acquisition costs of the medication are most important because surgery down the road may be covered by different insurance. Patients typically switch insurance coverage every several years, and the insurance provider that is covering the cost of the expensive medication may not be held responsible for the cost of surgery down the road. So the cost to the insurance provider of current medications may not mitigate savings in the future, which is an important consideration to the payers because their expenses may not be balanced by savings.

: I think that’s a great point, and something that I always think is so fascinating, at least for inflammatory bowel disease, is we thought that as we had these biologics being approved and a lot more guidelines were incorporating them that we would see reduced surgery rates, for example, or we would see reduced extraintestinal manifestations and reduced disability.

In the United States, there is still a big delay to start [our patients on] these medications…, so there’s a long lead-up to start the biologic. And during that time, the patient might be inappropriately managed with medications that are not therapeutic enough for them or optimized enough for them, and that’s the curative time [during which] they’re most vulnerable. The window of opportunity to start a good drug is not happening, so they’re getting surgery, and the costs are high in that up-front phase, and they still need to go on a biologic [postoperatively].

At least in the United States, unfortunately, the community hasn’t necessarily adopted the early use of biologics, which is really important. So the costs haven’t necessarily been driven down.

: You point out a very interesting dichotomy between gastrointestinal disease and rheumatologic disease [because] in gastrointestinal disease, inflammatory disease, surgery is the initial treatment for active disease, whereas in rheumatologic disease, the surgery is usually a result—or treats the results—of chronically active disease later on.

: I think it’s the same. It’s just that we do think it’s a chronic progressive disease similar to rheumatoid arthritis and other rheum conditions, but we do have this window of opportunity if we start the drug at the right time. If it’s early, you can prevent that progression, and the surgeries that we typically perform in inflammatory bowel disease are either resection for obstruction or resection for very active colonic disease, so a colectomy. Both of these conditions can be prevented if the right drug is started at the right time.

Sometimes by the time a patient is going to surgery, they’ve had years of chronic progressive disease that has been inappropriately managed, not optimized, no outcomes being met, and the ultimate result is surgery. By the time they see some of us, the disease has smoldered for so long that you haven’t had a chance to make an impact, so surgery becomes the only option. You do want to protect against that progression again, and you want to kind of do some postoperative prophylaxis, and that’s where the biologic [postoperatively] comes into play.

: One thing I do want to add is we talked about the driver the specialty drugs is one biologic but the other things that unplanned care- while we talk about the surgery because surgery could be planned or unplanned but those unplanned as you said, obstruction, the patient coming in for emergency care as well as readmission because many of these patients have multiple readmissions. These unplanned in-patient visits and multiple readmissions are where it really drives up their medical cost as well.

 You all brought up some great points, from readmissions to therapeutic cost to delaying surgery and also the impact that has. If it’s a 3-year benefit and we have high turnover in a plan, you might not see the benefit or the return on investment to that patient that you’ve paid for. These are all really great comments.

One thing that really resonated with me, though, was starting the right therapy for the right patient at the right time. We utilize step therapies, stepping through different frontline treatments that may not always be best, but they might be in terms of a treatment pathway. One of the things we’re seeing in psoriasis and other diseases is certain patients with certain risk factors might need a higher-cost therapy up front. They don’t end up saving on the cost over time based on the cycling through different therapies and the avoidance of those loading doses that really cost a lot to the plan. I really like how you teased that out.

This activity is supported by an educational grant from Boehringer Ingelheim.

Videos

A panel of experts review the key drivers contributing to the economic impact of inflammatory diseases in the United States.

Cost Drivers Contributing to the Economic Impact of Inflammatory Diseases

 When we think about these diseases, we really need to focus on the humanistic burden. Dr Chen, I’d love to get your thoughts as we kick this off. What are some of the humanistic and economic impacts that affect patients with inflammatory diseases? That can range from their quality of life and presenteeism at work to direct medical expenses like ED [emergency department] visits and hospitalizations and even indirect costs such as health care resource utilization. I’d love to hear your perspective on that as a payer.

: Exactly as you said—patients with rheumatoid disease are impacted significantly in their quality of life because of the pain, the medical treatment, surgeries they go through, and also impaired function. [That] not only [affects] them, but also [affects] their family and their coworkers as well when we talk about direct and indirect economic impacts.

We all know they have such a high health care cost that’s due to…the specialty drugs…as well as surgery and in-patient care. Those are the direct costs…,but some of the indirect costs that you have mentioned [are] a decrease in productivity at work, their coworkers significantly having to help them, as well as earlier disability and disability payment. Also, transportation, medication cost, and the costs for individuals with inflammatory disease can just go on and on, and to your point earlier, the mental health impact is not even being explored.

 Absolutely, I don’t know if any of our colleagues have any more to add. One thing that really stands out to me is as you mentioned, there are other indirect costs in terms of caregiver burden, but also that this disease is something these patients will live with. Our goal is for them to live a highly productive life, but when you have health care resource utilization and have to travel and have transportation vulnerability, [that] can really impact the patient as a whole.

: I agree, and I think along those lines, exactly as you said Dr Chen. You mentioned disability, and we’re increasingly recognizing that disability is a major comorbidity for these patients, both related to the disease manifestations itself but then also to the stress of the disease and its impact on their day-to-day life.

Something that we’ve been adopting in gastroenterology is actually disability- related quality of life and using that as an outcome for our patients because it’s a big deal for patients to not be able to get through the day, not be able to go to work or manage their personal life. I think we increasingly understand how…immune-mediated inflammatory diseases are impacting disability. We’re recognizing that it’s an outcome that we need to improve upon for their lives.

: On a more positive note, in rheumatologic diseases, disability used to be an inevitable consequence of the disease [despite] the treatments that we had, but over the past 25 years with biologics available, disability has been markedly decreased. Patients with rheumatologic diseases can now look forward to normal life and normal function and not necessarily anticipate surgical procedures. It used to be when I started in rheumatology that patients would anticipate having both hips and both knees replaced, surgery on their hands, and nowadays a patient with rheumatoid arthritis treated aggressively can expect to have a normal life managed with once-weekly or biweekly medication.

: That’s amazing. Just that progress alone is wonderful.

: One thing I do think is important to note is the overall cost for these patients. I think a lot of times we focus on the medical expense, but commercial patients tend to be very young because most of our inflammatory [diseases] tend to onset at a younger age. It’s important for us to incorporate those indirect costs like the disability that you guys talk about because many commercial payers are self-funded. And if we just look at it as we compare it with Medicaid or Medicare, I think we’re not…looking at what the commercial payers are paying for that.

Experts discuss the humanistic and economic impacts that affect patients with inflammatory diseases.

Humanistic and Economic Impact of Inflammatory Diseases

® stakeholder summit program titled “Interchangeable Biosimilars in Inflammatory Diseases.” I am Dr Ryan Haumschild, director of pharmacy services at Emory Healthcare and the Winship Cancer Institute in Atlanta, Georgia.

Joining me today in this discussion are my colleagues, Dr Jonathan Kay, the Timothy S. and Elaine L. Peterson Chair in Rheumatology; professor of medicine and [of] population and quantitative health sciences, director of clinical research in rheumatology, and the executive codirector of the MD-PhD program at UMass Chan Medical School, UMass Memorial Medical Center [in Worcester, Massachusetts].

Dr Maia Kayal, assistant professor [at the] The Susan and Leonard Feinstein IBD [Inflammatory Bowel Disease] Center [and in the] Dr Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai [in New York, New York].

Dr Kimberly Chen, senior health plan executive, expertise in Medicare, dual Medicaid commercial market.

Today our panel of experts will provide an overview of the clinical, economic, and humanistic burden of inflammatory conditions in the US, discuss the role of biologics and biosimilars in disease management and practical considerations for drug selection, define interchangeable biosimilars, and finally discuss the potential value of these agents to patients, payers, and providers in the treatment of inflammatory diseases. Thank you and let’s begin.

As we start this discussion today, I think it’d be really important to provide an overview of the clinical, economic, and humanistic burden of inflammatory conditions in the United States. Dr Kayal, could you give an overview of the clinical manifestation of these inflammatory diseases, focusing on the prevalence, some of the clinical impact, and even risk factors that we should be considering?

: Of course, thank you for the question. We know that immune- mediated inflammatory diseases have a prevalence of about 5% to 7% in the United States. The type of immune-mediated inflammatory diseases can be grouped based on the primary system that’s involved.

So in gastroenterology, which is, of course, my specialty and the area that I know the most about, we can group them according to inflammatory bowel diseases. This includes [Crohn] disease and ulcerative colitis. In rheumatology, Dr Kay’s specialty, of course, we have spondyloarthropathies, and these include ankylosing spondylitis, psoriatic arthritis, and then in addition to [those], rheumatoid arthritis. There are also immune-mediated inflammatory diseases in dermatology. These are psoriasis and hidradenitis suppurativa. Of course, the clinical manifestations vary for all of these diseases according to the systems that are involved. There’s no 

 risk factor for all of these diseases, of course, because they are across a wide spectrum of organ systems.

We do think that there might be a genetic predisposition to many of these conditions. Across the board, we think that tobacco use might be associated as a risk factor with some of these conditions, obesity, and age, but truly we haven’t figured out the precise risk factors for all of them. Again, we do know that perhaps in more cases than not, there is a genetic predisposition.

 That was an excellent overview, and obviously there’s a lot to consider. When we think about that, there’s also the consideration of comorbid diseases. We know that these comorbid diseases are on the rise, causing considerations for payers and providers, and uniquely there’s becoming more literature around metabolic disease and other things that we’ve really got to think about when we’re treating the patient as a whole. Dr Kay, maybe I can transition to you. What are some of the comorbid conditions that are typically seen in patients with inflammatory disease?

: Inflammatory diseases tend to increase the risk for cardiovascular disease. Atherosclerosis accelerates with chronic inflammation and malignancies. Lymphoma is also increased in its incidence in patients with inflammatory diseases, typically with more active inflammation.

For example, in rheumatoid arthritis, with the most active rheumatoid arthritis, the risk of lymphoma is markedly increased; however, with control of the disease and those comorbid conditions, the risk is decreased. In rheumatoid arthritis, interstitial lung disease is a major comorbidity that occurs in about 7% of patients with rheumatoid arthritis. Again, [it’s] treated the same way as rheumatoid arthritis, with anti-inflammatory therapy.

There are also comorbidities such as depression, which can occur as a reactive depression. We’re not really sure as to what the pathophysiology of depression associated with inflammatory diseases might be. We just presented a study at the European Alliance of Associations for Rheumatologymeeting that showed that there’s a 1.2-fold increased hazard ratio of postpartum depression among women with inflammatory arthritis compared to women without rheumatic disease. The risk of depression is increased in patients with inflammatory disease.

So atherosclerotic cardiovascular disease, lymphoma, interstitial lung disease, depression, and then of course the comorbid conditions that are associated with heart diseases, such as spondylarthritis, [which] is associated with inflammatory bowel disease or with uveitis or psoriasis. There [are] a number of comorbid conditions, most of them are shared pathophysiology and shared risk, but some of them are a result of chronic inflammation.

 Based on that response, there’s a lot to consider. I think one of the things you really highlight is the importance of mental health. We know with these patients, a lot of them are going to be on more chronic treatment, and if we want them to be successful, sometimes you got to really improve some of those underlying comorbid diseases to have a good proportion of days covered, adherence so a patient can really have better resolution of disease and better control.

Hopefully, that’s something that we can discuss more today because I feel like not only is it choosing the right treatment, it’s maintaining the right motivation and really focusing on all aspects of that patient as you so eloquently pointed out.

Maia Kayal, MD, MS, and Jonathan Kay, MD, provide a clinical overview of inflammatory diseases and describe comorbid conditions typically seen in patients.

Clinical Overview of Inflammatory Diseases

Hi, I’m Justina Petrullo for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of July 10th, 2023.

 where stakeholders can make public comment on whether clinical efficacy testing for biosimilars is necessary for regulatory approval.

 in the United States, Yuflyma (adalimumab-aaty), a biosimilar referencing Humira that is also 1 of 8 adalimumab products expected to launch in July.

 on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.

 on the market: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp). The launches come after 5 launched over the Fourth of July weekend.

Number 1: After years of waiting and legal battles, the 

 expected to launch in July 2023 have entered the market.

To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of July 10, 2023.

The Top 5 Biosimilar Articles for the Week of July 10

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, and Sneha Sharma, PharmD, director of specialty clinical solutions at Magellan Rx Management discuss some of the major topics of concerns surrounding the use of ophthalmology biosimilars.

So far, there are 2 ophthalmology biosimilars on the US market, both of which are ranibizumab products and vascular endothelial growth factor inhibitors (anti-VEGF). Biosimilars for ophthalic indications are new globally and the biggest challenge facing this sector of the industry is how to get patients and providers to trust that biosimilars are as safe and effective as their originators.

This interview is part 3 of a multimedia series on ophthalmology biosimiars in the United States expanding on the discussion from our LinkedIn Live event “

In Sight: The Future of Biosimilars in Ophthalmology Care

, a written Q&A Kyung-Ah Kim, executive vice president of Samsung Bioepis. Click here for 

, a podcast episode of Not So Different featuring Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars.

How have payers responded to the influx of ophthalmology biosimilars so far and are they preferring interchangeable biosimilars?

The ophthalmology biosimilars came onto the market late last year. So the influx has been dependent on a few factors [and] we haven't seen much uptake yet. Avastin [reference bevacizumab] is the most cost-effective product in this category. So there's still some uncertainty as to how the biosimilars will be preferenced in this category.

Some experts are concerned about anti-VEGF biosimilars having an interchangeability designation because the label does not impact biosimilars dispensed through the medical benefit, potentially causing confusion over what the label means. How do payers view interchangeability generally and how will these views shape the biosimilars space?

Yeah, I feel the interchangeability designation certainly allows for better access to biosimilars. Especially with the automatic substitution piece, I feel that the payers are thinking ahead of the game in thinking these might be easier to preference, because they have that automatic substitution piece, especially in the pharmacy benefit, where they won't really need a new prescription to substitute an interchangeable biosimilar for a reference product. So definitely has some impacts there.

For the medical benefit, I feel like the impacts are still unknown because Cimerli [reference ranibizumab] just came out as the first medical benefit interchangeable biosimilar. All the other ones were on the pharmacy side. So the impacts for medical benefit are unknown, but I feel like this will only create more flexibility and confidence in the provider community to prescribe biosimilars for this category.

So far, ophthalmologists are very concerned about the safety of ophthalmology biosimilars, particularly because all the FDA-approved ophthalmology biosimilars so far are administered via an injection in the eye. How might payer preferences for ophthalmology biosimilars impact physician confidence in these products?

Sure, it's a valid concern—you are injecting a drug into the eye. But the reference product for these ophthalmology biosimilars has little to minimal interocular inflammation or adverse events. So, a biosimilar should behave similar to their reference product. As we've seen in other categories where biosimilars have been introduced, they've been used safely and efficaciously. And our clients, payers, health plans, [almost] everyone is pretty much familiar with step therapy, so providers should be familiar with that if preferencing does occur for the biosimilars.

The FDA has said that it granted Cimerli, a ranibizumab biosimilar, interchangeability without a switching study data because the company asked for it and because the administration route did not require additional testing. How do you think this decision will impact the overall view of interchangeability designations and the safety of ranibizumab biosimilars?

Right, you're correct. The second ranibizumab biosimilar, which is Cimerli, did get an interchangeable designation without a switching study. Now, when we look at the data, [the manufacturer] did supply strong clinical data and robust analytical data, which led the FDA to believe that there is no risk in switching between the biosimilar and the reference product. And that is why they granted this approval. So, in my opinion—having that approval in place [without] having like the switching study—if there is strong data as compared to switching study and as long as there is no risk for FDA, that approval is okay and should not really create any confusion in terms of interchangeability.

How do you think the Inflation Reduction Act [IRA] will impact the accessibility and affordability of biosimilars?

The IRA is still very, very new and all of us in the managed care community are trying to find out what is going to be the impact with biosimilars. So one thing that comes to mind is that some of the select biosimilars are going to have a little bit of extra payment from Medicare, and that is going to be temporary for 5 years, but still it is an incentive. So, I feel like that particular thing will certainly boost the biosimilar prescribing and make biosimilars more flexible since Medicare is going to be raising a little bit of payment rates on them.

Usually, when the United States is introduced to biosimilars in a new disease state, it can look to the European Union’s real-world evidence to boost physician and patient confidence. However, the ophthalmology biosimilar space is very new globally. How do you respond to ophthalmologists, payers, and patients when they express concerns over the lack of real-world data?

As with anything, education and experience are the best teachers and there is lack of real-world data. But at the same time, as I mentioned, we've seen biosimilars be used safely and efficaciously in other disease states. And we do have safeguards in the US. If there are adverse events that need to be reported, the FDA does intervene. But we should expect the biosimilars to behave similarly and the studies that have been conducted are also a standard in the US, so we shouldn't see any issues.

What actions can clinics take to better advocate for ophthalmology biosimilars and instill greater confidence in the safety of these products?

Sure, so clinics can educate the patients and the staff on what studies have been conducted, how biosimilars have been safely used in other disease states, intervene with pharmacist Lunch and Learn education. Again, education is key. And you can arm yourself by being comfortable with using the products, similar to how Avastin came about in this market [and] other drugs. We [originally] weren't sure how they would behave post market. So there is a lot of opportunity to just educate the patient.

Prerakkumar Parikh, PharmD, and Sneha Sharma, PharmD, from Magellan Rx Management, tackle some of the biggest concerns ophthalmologists have regarding emerging biosimilars for ophthalmic conditions, including interchangeability as well as lack of real-world evidence and education.

Part 3: Drs Sneha Sharma and Prerakkumar Parikh Quell Concerns About Ophthalmology Biosimilars

Here are the top 5 biosimilar articles for the week of July 3rd, 2023.

Number 5: It was found that cancer treatment, pediatric population, and coverage restriction of reference products were revealed as some of the 

strongest factors associated with biosimilar coverage decisions

 by US commercial health plans relative to reference products.

Number 3: In his latest column, Sarfaraz K. Niazi, PhD, took a look at 

common misconceptions about biosimilar development

 and expressed how companies can seize new opportunities to save the US biosimilar market and generate profit.

Number 2: The Center for Biosimilars® provided an updated look on the adalimumab biosimilars that are 

 as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.

Here are the top 5 biosimilar articles for the week of July 3, 2023.



The Top 5 Biosimilar Articles for the Week of July 3

Here are the top 5 biosimilar articles for the week of June 26th, 2023.

 of biosimilars can assist in promoting their use and defeat misconceptions and misinformation related to generic drugs and biosimilars.

 find that a rituximab biosimilar, BCD-020, was safe and effective in pediatric patients with lupus nephritis.

Number 3: The ranibizumab biosimilar XSB-001 (Ximluci) 

 to the originator (Lucentis) in a phase 3 trial in neovascular age-related macular degeneration (nAMD).

Number 2: An analysis of 25 studies finds adalimumab, infliximab, and etanercept biosimilars 

 in comparison with their originators in the treatment of rheumatoid arthritis.

Number 1: In his latest column, Sarfaraz K. Niazi, PhD, 

 about biosimilar development and expresses how companies can seize new opportunities to save the US biosimilar market and generate profit.

Here are the top 5 biosimilar articles for the week of June 26, 2023.

The Top 5 Biosimilar Articles for the Week of June 26

Unless pharmacy benefit managers (PBMs) stepping up to support biosimilars and provide broad access to these lower-cost products, the promised savings from ranibizumab and adalimumab biosimilars are going to develop slowly and a healthy competitive marketplace will be in jeopardy, said Juliana (Julie) Reed, executive director of the Biosimilars Forum, in an interview from Asembia 2023.

Although anticipated savings related to adalimumab and ranibizumab biosimilars are expected to develop over a long period of time, how long do you think the US will have to wait to see big price changes, and what needs to happen to ensure ample competition between products?

So I think that we could see immediate savings if the PBMs [pharmacy benefit managers] changed their model—they embrace biosimilars, they embrace competition, and they moved towards providing that and providing access. Otherwise, the savings will be slow. And it's not because [the Forum's] members did not develop or take all this time. If we have [9] biosimilars to Humira [adalimumab] is launching at 10 years of development, that's [90] years of development, and over $2 billion spent. And that's the concern—that all this time, these years, and all this money but PBMs won't provide access, and I mean preferred access. They need to support the industry. They need to support the competition. 

IQVIA and other economists have said that we could see close to $155 billion in savings by 2025. That's 2 years from now and that has a lot to do with those biosimilars launching. Those are real numbers and there's concern that those savings will not be realized. And I think the question will be why? Because we certainly we developed the biosimilars and we're bringing them to the marketplace, and we know they're safe and efficacious and approved by the FDA. So if we don't achieve those savings, the question is why, and we know that it's because we don't have access to the market and we're not able to compete.

Juliana (Julie) Reed, executive director of the Biosimilars Forum, predicts how long it will take for savings from adalimumab and ranibizumab biosimilar competition to fully manifest and how stakeholders can champion for better market competition for biosimilars.

Julie Reed: When the US Could See Meaningful Savings From Adalimumab, Ranibizumab Biosimilar Competition

Here are the top 5 biosimilar articles for the week of June 19th, 2023.

 that acts as an invitation to biosimilar developers to decrease the cost of testing, potentially opening the door for companies to reduce nonclinical testing of biosimilars entirely.

Number 4: A survey of patients with rheumatoid arthritis found that those who had 

 reported higher disease severity, poorer treatment adherence, and poorer quality of life compared with patients who stayed on the reference product, highlighting the dangers of the nocebo effect.

Number 3: After 8 years of trastuzumab biosimilar competition and slow uptake, 

a new report showed that trastuzumab biosimilar

 discounts from the reference product (Herceptin) doubled between 2019 and 2022.

SmithRx became the first pharmacy benefit manager

 (PBM) to announce it will cover Yusimry, 1 of 9 FDA-approved adalimumab biosimilars; Celltrion Healthcare received a thumbs-up from the FDA to test a biosimilar for Ocrevus; Alvotech and Teva Pharmaceuticals settled with Johnson & Johnson over their biosimilar referencing Stelara.

Number 1: Coherus Biosciences and AbbVie 

 regarding Coherus’ partnership with the Mark Cuban Cost Plus Drug Company and an adalimumab biosimilar, and Celltrion and Bio-Thera Solutions expanded their respective partnerships to include more biosimilar products.

Here are the top 5 biosimilar articles for the week of June 19, 2023.

The Top 5 Biosimilar Articles for the Week of June 19

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. 