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 24th, 2023.

price of Humira (reference adalimumab) has risen

 so dramatically over time that the list prices for new adalimumab biosimilars are now significantly higher than the original price of the originator, according to a report contextualizing net prices of adalimumab and the role of rebates.

Number 4: The Center for Biosimilars® provided an 

updated look on the adalimumab biosimilars

 that are coming down the US pipeline 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.

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

Samsung Bioepis’ Biosimilar Market Report

 showed a strong correlation between biosimilar usage and decreased drug prices, proving that biosimilars are delivering on the promise of savings and price erosion.

Number 1: Sarfaraz K. Niazi, PhD, detailed his efforts to 

 to draft legislation that would remove interchangeability requirements and animal toxicology studies for biosimilars.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of July 24, 2023.

The Top 5 Biosimilar Articles for the Week of July 24

 As we jump into understanding the indications and treatments, I’ll turn to Dr [Jonathan] Kay. Could you provide an overview of the existing FDA-approved biosimilars for adalimumab [Humira] and the differences between the low and high doses that we’ve heard so much about?

: As of June 19, 2023, [there are] 9 FDA-approved adalimumab biosimilars. Some of these are low concentrations. Some of them are high concentration. There’s 1 company which has both a low concentration and a high concentration in a citrate-free buffer. Some of the adalimumab biosimilars are in a citrate-containing buffer. Others are in a citrate-free buffer. Most of the auto-injectors use a 29-gauge needle. One of them uses a 29-gauge needle or a 27-gauge needle. The 27-gauge needle is in the auto-injector and the 29-gauge needle is in the prefilled syringe. All of the adalimumab biosimilars that are being marketed, for the most part, have patient assistance programs. The patient assistance programs are comparable to that which is offered by the manufacturer of referenced adalimumab. So there’s a wide array of adalimumab biosimilars that are coming on the market. One of them, adalimumab-atto has been marketed since January 31 and has a head start. But as of July 1, there are going to be 7 more adalimumab biosimilars that come to market. And then in September, we’re going to see the last of the 9 adalimumab biosimilars coming to market in the United States. Why 2023? There was patent litigation by AbbVie with each of the biosimilar manufacturers, which stalled the availability of biosimilar adalimumab. Biosimilar adalimumab was available in the European Union and elsewhere in October 2018. But in the United States, each of the biosimilar manufacturers reached an agreement with AbbVie whereby they would pay a royalty to AbbVie for intellectual property rights and would be allowed to release their biosimilar to market in 2023 with prespecified dates.

 That’s a great overview and a great background as to maybe why we’re seeing it here, and maybe why we can also look to European data if we’re having any hesitation in terms of uptake here in the US.

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

Jonathan Kay, MD, provides an overview of the existing FDA-approved biosimilars for adalimumab.

Existing FDA-Approved Biosimilars

Dr [Kimberly] Chen, we talked about some of the challenges from the provider’s perspective. But I know there are challenges also from the payers’ perspective. What are the challenges associated with biosimilar uptake?

: I think one thing important to note is we definitely need to educate the providers and make sure there’s an incentive for providers as well. And to everybody’s point, making sure providers are also supported. From the health plan perspective, we have a whole team of pharmacists and a whole team of case managers who can further educate in making sure the patient or members are compliant with taking their medication and understanding what biosimilars are. And how everyone can work closer together to support the members?

 Close collaboration is so important. But we also know strategy and design of the benefit also plays an important role. Dr Chen, what are some of the strategies payers can employ to improve the uptake of biosimilars? And how does that intersect with the plan design when you’re creating kind of that incentive for use?

: It goes back to the strategy a lot of times and we already talked about the education. Educating the members as well as the providers. Because providers in large health systems are very familiar with biosimilars, the biologic concept. But when you go to the more rural areas, many providers do not know about biosimilars. I think definitely that education to the provider, alignment, and collaboration between the provider and health plan, is always subsequently going to be a win-win to better support our members. But to talk about the plan design, I think we all talked about incentives for the members. Patients, how can we help them with the injection of the biosimilar, especially if it burns? Or can we send a home health care nurse to go help them, even though maybe their initial health plan does not provide that service? And then tier and try to get them into the formulary. Those are all different things we can do on the plan design.

 Excellent. Thank you for that overview. As we talk about biosimilars, there is sometimes extrapolation of data. You might have biosimilar data in rheumatology that you might need to extrapolate to GI [gastrointestinal]. And this happens sometimes just based on the cost to fund the studies and kind of the clinical overview. Dr [Maia] Kayal, what are your thoughts on the extrapolation of clinical data across multiple indications?

: I think it’s appropriate in the setting. We talked about how a biosimilar has really no significant clinical difference in terms of safety and efficacy from the reference product. So this idea and based on the idea of extrapolation, then the FDA can approve a biosimilar for all the indications that the reference product is approved for. For example, you just mentioned if the reference product is approved for rheumatologic and gastroenterology indications, then the biosimilar can similarly be approved for the same indications. I think if we get to the reason why we even have biosimilars, it makes complete sense to extrapolate across clinical indications. If the reason that we’re pursuing this road of biosimilars is to reduce costs, to get more drugs into the patient’s hands, to reduce the time to approve a new agent and the cost that’s associated with that approval, if you have the data to support that the biosimilar is essentially very similar to the reference products in terms of pharmacodynamics and immunogenicity and safety, then it makes sense to approve across clinical indications to the reference product. I think it’s been a welcome addition in terms of the FDA approval process that all the indications for which the reference product is approved to carry the biosimilar because it just decreases the time that we get these approvals.

 So not just highly similar of a molecule, but maybe highly similar to the reference indications.I like how you explain that.

Kimberly C. Chen DO, MSHLM, and Maia Kayal, MD, MS, review the challenges related to biosimilars from the payer perspective and strategies payers may employ to help improve the uptake of biosimilars.

Challenges Payers Face With Biosimilars

Julie Reed, MS, executive director of the Biosimilars Forum, weighed in on some of the biggest policy changes that could impact biosimilars, including the implementation of the reauthorization of the Biosimilars User Fee Amendment (BsUFA III) and the investigation into pharmacy benefit manager (PBM) practices.

What are some of the big biosimilar policy changes that the industry should be keeping an eye on and what actions can providers and administrators take to push them forward?

Absolutely. There's a couple key ones right now—and I sound like broken record so I apologize—but right now, the Senate Finance Committee and Congress are looking at PBM transparency. And I think that's a good start, but it doesn't go far enough, especially for biosimilars. We know what the problems are. We know that they're not providing competitive access to biosimilars. They're not preferring biosimilars. They're not supporting their uptake and lower cost. They're asking for high rebates, which the opposite of what we're trying to do. We don't want to add cost, we don't want to add rebates to a biosimilar. We want to give the lower list price and lower patients out-of-pocket [costs].

I think another key piece is—and we're excited about—is under the BsUFA III user fee negotiations. We will be working with the FDA to streamline development of biosimilars, which is a critically important. We're partnering with the FDA and bringing our collective experience with getting approvals across the world for biosimilars and the decades we've been doing this. There's ways we can create efficiency within biosimilar development. And I think that'll be key. If you can approve a biosimilar in less than 10 years, which we should be able to do, and if we can reduce the costs, that will have an impact on the outcome for patients' costs and what we can do for them, and so I think that's right. 

We will continue to work closely with CMS. The biosimilar special rule was part of the Inflation Reduction Act, and that is part of the the drug negotiation package that they're implementing. We continue to to work with CMS and that team so that will this special rule is implemented in an effective and positive manner for the long-term sustainability of the biosimilars industry. So, I think those are the 3 key things and, of course, will always be weighing in on patent reform and reducing barriers to bringing biosimilars to the US marketplace.

Julie Reed, MS, executive director of the Biosimilars Forum, takes a look at the 3 policy initiatives that could have the greatest ramifications for the US biosimilars industry.

The Top 3 Policy Initiatives That Could Impact the US Biosimilar Market

Here are the top 5 biosimilar articles for the week of July 17th, 2023.

Number 5: A review article shed light on the 

, including how these products are being priced, strategies companies are using to make their product stand out, and recommendations for policymakers to ensure the accessibility and affordability of these products.

 for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.

reintroduced the Biosimilar Red Tape Elimination Act

 to Congress. The bill aims to get rid of switching study requirements for companies looking to obtain an interchangeability designation for a biosimilar.

The US gained 2 more adalimumab biosimilars

Number 1: The list price of Humira (reference adalimumab) had 

 over time that the list prices for new adalimumab biosimilars are now significantly higher than the original price of the originator, according to a report contextualizing net prices of adalimumab and the role of rebates.

Here are the top 5 biosimilar articles for the week of July 17, 2023.

The Top 5 Biosimilar Articles for the Week of July 17

 And with those great opportunities biosimilars provide, there are also challenges. Dr Kay, I don't want to come to you for just challenges, but I feel like I'd love to hear your perspective of some of the challenges that you've experienced as a provider related to biosimilars and inflammatory conditions.

: The biggest challenge is that the patient needs to share in the savings. A patient accepting a biosimilar, which is equivalent in effectiveness and comparable and safety is not giving up anything, they're gaining treatment with effective medication. But to make that change for the sake of saving the payer money, or the pharmacy benefit manager money, and not sharing in those cost savings, really doesn't make sense. So the success of biosimilars is dependent upon including the patient in the economic advantage of the biosimilars. In terms of challenges, a patient who's doing well on reference biologic medication, when faced with the suggestion of changing to a biosimilar, is going to ask why; [they might say] “I'm doing very well on the medication that I'm taking. What's in it for me?” In Europe, in countries where there's a strong social commitment, such as the Netherlands or Scandinavian countries, the individual patient follows the Enlightenment concept of the social contract and is willing to give up a little bit of something themselves for the good of society. So biosimilars have been very successful, especially in the Scandinavian countries, but also in European countries, such as the Netherlands, where there's a strong sense of social responsibility among the population. In the United States, it's a bit more complicated and patient education is critical. In the Netherlands, there was a study done in Nijmegen, where patients switched from reference infliximab to biosimilar infliximab and they found that although there was no change in disease activity over 6 months, 25% of patients discontinued the biosimilar after 6 months for reasons that were mostly subjective. The same groupconducted another study in which they switched patients from reference to etanercept to biosimilar etanercept and this time, they involve the pharmacists and nurses in the clinic to provide the patients with education. This was not a controlled study because patients were only provided with information about biosimilars. But patients who are educated about biosimilars had about an 8% to 10% discontinuation rate at 6 months, which compared to a historical cohort was within 2% of the historical cohort. So, first of all, there was a much lower discontinuation rate, and it was comparable to the discontinuation rate from patients who had previously been treated with reference products. So, education is incredibly important when initiating treatment with a biosimilar. And it's important to educate the patient initiating a reference product, but with a biosimilar to educate the patient that biosimilars have been studied extensively developed very carefully, and shown to be equivalent in efficacy and comparable in safety and immunogenicity with that education. If the other component of sharing in the financial savings benefits the patient, then we can be quite successful in using biosimilars in the United States.

: I agree with Dr Kay 100%. I think taking the time and spending it on education is imperative because I think especially with the injectable biosimilars, it's difficult for patients to be cruising on the reference product injectable, and then all of a sudden in 1month, get a new package with new packaging, a new form of administration, especially with adalimumab. Adalimumab reference product is citrate-free and patients really enjoy them because it doesn't cause burning or stinging when they inject. But some of the new adalimumab biosimilars might still have citrate, and patients might not be aware. They also may not be comfortable with the packaging. Do they have to pull it up into a syringe? Is it still an easily employed pen? I think taking that time upfront to understand what the patient’s perspective is on switching to a biosimilar, allay their concerns, and then understand even on a deeper level which biosimilar will they be prescribed, what that looks like, how can they use that, is really key to get them to buy into the idea of a biosimilar. And then you're right. The cost savings have to rally onto the patient because otherwise, you worry what's it all for?

: There's a big difference between the self-administered biosimilars and the infusible biosimilar. Infliximab is an infusible biosimilar. And the uptake of biosimilar infliximab initially when it was first released in 2017 was very low in the United States largely because it was not on the formulary in most institutions. But as institutions became more aware of biosimilars, and especially with 340B institutions, the savings became quite significant. Institutions started to use biosimilars and found them to be quite successful. For the patient sitting in an infusion chair, unless they read very carefully the writing on the bag, they're not going to notice that they're getting biosimilar infliximab compared to reference infliximab or even which biosimilar. And the experience that we've had is that when the biosimilar has changed to a different biosimilar there's been no increase in adverse effects. As you pointed out, the self-injectable biosimilars come in either a syringe or a pen and the autoinjectors are patented and proprietary to the manufacturer of the reference product. So each biosimilar comes up with its own autoinjector, which is visible to the patient. Some of these might actually be better than the reference product. And the reference product has a 3-step autoinjector, whereas a 2-step autoinjector just involves pushing it down on your skin, and everything else happens, you can't stop it. You just inject and then you hold it there and make sure that the injections have gone in completely for 10 seconds, and then you're done. So there are autoinjectors that are not cylindrical that are shaped with a flat surface on 1 side so they don't roll off the table. There are autoinjectors that have wider grips for patients with arthritis and compromised hand function. So the autoinjector is actually an opportunity for a competitive advantage over a biosimilar since the patient doesn't really feel the economic impact that much. And how do you differentiate yourself? You can't say that [they’re] more effective because a biosimilar cannot be more effective than the reference product. It can be a little bit safer. There's a biosimilar, etanercept, which has 3.7% injection site reactions in clinical trials compared to 17.2% with the reference product. The etanercept biosimilars won't be released in the United States until 2028, but there can be advantages as you pointed out. Reference adalimumab in the low concentration contains citrate and the high concentration does not contain citrate. And the citrate buffer contributes to the burning sensation. Some of the biosimilar adalimumab in the low concentration are citrate free, so that can be an advantage. The needle can be a smaller gauge. It can also be sharper. Some needles, patients reported, [are] somewhat dull and hurt a little bit more when they go in. So, there are plenty of opportunities for competitive advantages of biosimilars. But you also point out that education should be done by the provider, which is very important. When you have a patient with inflammatory bowel disease, comorbidities, compliance with medication, or activity of the disease, all of these things have to be included in a very brief, relatively brief appointment during which you don't have a lot of extra time to counsel the patient adequately about the differences between a biosimilar and a reference product. So the challenge to the provider is, how to educate the patient adequately about biosimilars while still addressing all of their medical needs.

 One thing to build off of that with provider challenges is also many large practices and health systems have their own integrated specialty pharmacies that they can utilize for patient education and coordination through the EMR [electronic medical records]. And one thing that's going to be really interesting is we have more biosimilars. We've already had this, but it's a biosimilar to be managed to the pharmacy benefit, so there's restrictive payer coverage. Only certain pharmacies can dispense. We actually ran a study that was published in the American Society of Health-System Pharmacy of the Emory Specialty Pharmacy [Atlanta, Georgia] that when we dispense internally, same provider, we had 22.5% better adherence when it was filled internally vs a PBM [pharmacy benefit managers]-owned specialty pharmacy. So that's another thing that we're definitely going to have to tug and pull on. How do we work with our payers if we're unable to fill internally as a provider to make sure that we've got good adherence data to have these patients be successful on the product.product?

: I couldn't agree with you more. At UMass Memorial Medical Center [Worcester, Massachusetts], we have our own internal specialty pharmacy. And we have pharmacy liaisons that help us with prior authorization and interface with the patients. They follow up with the patient. Pharmacists speak with the patient, address concerns, and enhance compliance. But the problem is that if a patient changes insurance, then they're no longer able to use our internal specialty pharmacy. Unless all pharmacies were created equal, there is a difference among pharmacies, and I would use this platform to advocate, payers, that you'd be more liberal in supporting specialty pharmacies and allowing institutional specialty pharmacies to dispense these medications because so much of the direct involvement of the pharmacy liaison with the patient and with the provider is important in compliance. And compliance with the payer is going to result less in the way of comorbidities and consequences of inadequately treated disease. So, there should be an increase in the number and use of institutional specialty pharmacies. But the problem is that the PBMs typically own their own specialty pharmacies. And the PBM is also on the payers. PBMs are becoming all-powerful and have many different aspects, which makes it difficult for the institutional control of specialty pharmacy distribution of drugs, which is actually optimal for the patient to be widely available.

Jonathan Kay, MD, discusses challenges that patients may experience related to biosimilars for inflammatory conditions.

Challenges Associated With Biosimilars

 Now let's discuss the role of biologics and biosimilars and disease management. What are the practical considerations for drug selection? Maybe Dr Kayal, we can start with you. And then Dr Chen, I'll probably want to pull you into this conversation as well. But first, Dr Kayal, what are some of the opportunities that biosimilars have for inflammatory conditions from a provider's perspective?

: Biosimilars are really an exciting addition in terms of the adalimumab biosimilars this year, at least in immune-mediated inflammatory diseases because the number one most important thing that they're allowing us to do is get more drugs into more patients hands; the fact that they are lower costs, and hopefully we're seeing that lower costs translate into patient lower costs as well. It's just making the treatment class the biologics more accessible for patients. And this is a big deal because although we have a lot of different health care plans and different insurance, formularies, and managed care plans, it still is across the board, it can be difficult to get the right drug into the right patient at the right time. The cost has always been a barrier for patients so the biggest thing that has been really wonderful about biosimilars, and this started of course, with infliximab, biosimilars, years ago, and now again more recently with the adalimumab biosimilars, is that we're able to get the drug to the patient at the time that they need. So we were talking a little bit about step therapy before and we're increasingly understanding this step therapy is not necessarily the right approach for many of our patients who are starting with severe disease that can only progress or increase in severity. And for these patients, you really need to start a biologic early on and you don't necessarily want to waste time going through the different step-up or step-lateral approach. You really just want to start the biologic upfront, and the cost was a big inhibitor of that, and now with the biosimilars at the lower cost they afford, we're able to start the right drug earlier for our patients and really prevent the disease severity progressing.

 Many times historically, it was given to the providers to understand the value of a biosimilar but obviously, our providers have really caught on. And they understand the value that plays in treatment. And they understand that it can reduce the cost for the patient if the plan has it that way. So maybe we pivot from the provider perspective to a payer. As a payer, Dr Chen, what are your thoughts on biosimilars? And how are they really changing the landscape and some of these high costs disease states?

: As we have discussed earlier, the development of biosimilar drugs is much lower in cost in comparison to biologics, as well as the medication itself. It is much lower overall, in the cost itself, but also, ideally, it is used interchangeably where we are able to switch somebody already on a biologic to the biosimilar, which, could give us even more saving in the long run.It will increase our market competitiveness and overall create more innovations as well as, hopefully, cost saving in the long run.

 I’m hopeful that cost savings not only save for the employer group because I think that’s so important as they continue to cover newer innovative treatments, but for the payers also. Hopefully, that passes on to the patients as well because ultimately, we want them to be able to afford and have access to these medications.

Maia Kayal, MD, MS, and Kimberly C. Chen DO, MSHLM, discuss opportunities that biosimilars provide for inflammatory conditions from both a payer and provider perspective.

Opportunities Provided By Biosimilars

: Speaking of biosimilars, one of the things we haven't defined for our viewing audience is what a biosimilar is. Dr Kay, maybe you can speak to what is the biosimilar and maybe discuss the potential impacts of a lower cost compared to the reference product.

: Certainly, a biosimilar is a copy of a biopharmaceutical, which no longer is limited by patent. And that copy is an exact copy of the amino acid sequence but because these are produced in living cells, it can't be a completely exact copy. So there's slight variation in terms of post-translational modifications such as constellation, however, the definition in the biologics price competition and Innovation Act of 2009 is the biosimilar is highly similar to the reference product without clinically meaningful differences. It's expected to have similar quality, purity, and potency to the reference product and in practical terms, is studied in terms of analytical comparisons with the reference product, then shown to be highly similar without clinically meaningful differences. There's then a pharmacokinetic study that shows equivalent pharmacokinetic parameters, and at least 1 clinical trial and a disease for which the reference product is approved to show equivalent efficacy throughout the development process immunogenicity is assessed and the biosimilar is shown to be no more immunogenic than the reference product and also comparable in terms of safety. So essentially, a biosimilar is a copy of a biopharmaceutical, it's not a generic because generics are small molecules, where the active ingredient can be reproduced exactly. But the biosimilar, being a complex protein, is not an exact copy. But is shown in an extensive development process to be equivalent in its efficacy, and comparable in its safety to the reference product.

 Excellent overview. Thank you for going through that with us. So now that we've defined biosimilars maybe Dr Chen, what is the potential for these biosimilars to lower costs compared to this reference product?

: Now there is definitely a lot of opportunity in just talking about the development. On average, new medication will take minimally greater than 10 years and the development costs over $2.6 billion. But biosimilars actually take approximately 5 to 9 years and are only about $100 million. So you can even see the cost comparison on developing the drug itself. In 2020, the research actually showed that biosimilars have saved nearly a billion dollars and in 2022 they have actually projected a savings of over $30 billion. And if we continue the use of biosimilars, there's a potential savings of $183 billion in the next 5 years.

 It sounds like there's a great opportunity for biosimilars leveraging almost like our partners have in Europe to really decrease the cost of care and still provide high value.

Jonathan Kay, MD, and Kimberly C. Chen DO, MSHLM, define what a biosimilar is and discuss the potential for a lower cost than the reference product.

Savings Potential With Biosimilars

 As we know and has been pointed out, there's going to be barriers to treatment. Dr Kay, [as] someone who does a great job treating patients, and another expert in the field, I'd love to get your thoughts. With all these biologics available, it's really tempting to say we've got plenty, but we know that there are still barriers that are preventing patients from being on therapy long term. Could you discuss some of the barriers related to the access of biologics maybe from an economic and even health disparities perspective?

: Certainly the economic barriers are there because these medications are quite expensive. They're not necessarily expensive to the patient because the patient pays, in most cases a copayment that's relatively negligible compared to the cost of the medication for patients who have Medicare insurance and Medicare Part D; they're paying 20% of the cost of the medication up to the doughnut hole, and then the medication is covered fully. But the real barrier based on economics is an almost artificial barrier that's placed by pharmacy benefit managers because pharmacy benefit managers are companies that contract with payers to manage their formularies and they get paid an administrative fee based upon the list price of the medication. They also get discounts and postdoc rebates from the manufacturer so that the amount that they pay for the medication is much less than the list price. They share most of that rebate and discount with the payer. But they don't necessarily disclose the complete amount so that their profit is generated both by the administrative fees that they gain from the small proportion of the list price, and also that proportion of the rebates or discounts that they keep. So the economic barriers are generated by the pharmacy benefit managers tiers the formulary, essentially the way many of us who fly airlines choose to fly a specific airline or group of airlines so that we can get status on that airline and a greater likelihood of upgrades or something like that. The pharmacy benefit managers are aligning the incentives so that they can have the most patients on the medication that will give them the largest rebate from the manufacturer. The more patients they have on a given medication, the larger the rebate usually is from the manufacturer. So the pharmacy benefit managers require prior authorization, not because they're trying to help us determine the most appropriate medication for a patient, but rather because they're trying to align the medication that's prescribed for the patient with the medication that will give them the best advantage in negotiating discounts and rebates. So the economics are complicated; medications are expensive. They're expensive to someone, certainly to society, but not necessarily directly to the patient. But the cost of the medication and the opportunities for pharmacy benefit managers to gain rebates and generate profits limits access to some biologics because the providers’ choice is not completely free and is dictated by the pharmacy benefit managers’ formulary. There are certainly health inequities where disadvantaged groups don't have the same access to health care that everybody else does. And with limited access to health care, these medications are perhaps the least accessible since they're expensive and almost impossible to obtain without some sort of coverage assistance. Medicaid provides assistance so that those disadvantaged groups that are covered by Medicaid are able to have access to these medications, but for the uninsured, whether they're uninsured because they're financially limited or whether they're uninsured because they are not working in the employment sector—they may be retired and can't afford the coverage for prescriptions—those individuals are compromised in terms of their access to these very effective medications. So their health care disparities are not necessarily aligned with social inequities but are more economic difficulties. Retired individuals oftentimes have to go to work, bagging groceries at a local grocery store to get health insurance. [I have] not seen that at Starbucks, where baristas are retirement age, but I wouldn't be surprised if we start seeing that as well.

 I'm probably more of an economy guy myself, relating to your thing, but I definitely recognize what you're saying. It is a very tricky environment because you do have pharmacy benefit managers that are managing the benefit and also sharing some of the rebaiting. You also have health plans and employer groups that are trying to afford the increasing cost of care related to both medical and pharmacy benefit while pharmacy benefit managers may just see that pharmacy piece of it. There might be true medical cost offsets if you gave a patient therapy sooner. The more and more we aligned the benefits between pharmacy and medical, I think it's going to create better access and I think you really describe that well. And I do want to hit on health inequities because one thing that’s so important as providers and payers is that we come together to make sure that patients have an equitable chance at receiving a positive health outcome. And if they have transfer patient vulnerability and can't receive a biosimilar infusion, then how do we make sure we have something they can take in the comfort of their home? Because we know based on patient zip codes we can live 6 miles away or 300 miles away and they still have that same transportation vulnerability, and being able to attack that financial toxicity, transportation vulnerability, and make sure that we have equitable care, continues to be a challenge and something we have to work through even with extremely efficacious treatments.

: Transportation vulnerability isn't limited to being unable to attend an infusion center to get an infusible biologic. Transportation vulnerability oftentimes limits access to medical appointments, and limiting access to medical appointments often delays or even prevents treatment of active disease.

:I agree with that. I think along those lines, it's also about where patients work and whether their employer is even willing to give them time off to get the infusion, make it to that appointment, where they learn how to use an injectable. A lot of what we provide at our center is not only, of course the medical care and the medical support, [but also] the psychosocial support, because that's where, increasingly again, understanding that the psychological impact of this disease can be devastating. But if a patient doesn't have time to take off from work, to come and see you in the office, or even see their therapist that day, then it's just going to be a continuous downward spiral of the impact of the disease on their day-to-day.

: One thing I do want to note with all health plans, especially high-cost patients, usually they have a case manager within the health plan that can help support them in getting some of the social determinants of health issues, such as transportation, health plan, sometimes with an issue with the Medicaid sector, and sometimes with a commercial or self-funded group, it can make exceptions to pay for some of those care needs. So always keep in mind that collaboration between the health plan and providers is really a win-win to better support our patients, especially the ones with SDOH [Social Determinants of Health] needs.

Jonathan Kay, MD, reviews the barriers related to access to biologics such as economic barriers, health inequities, or disparities.

Barriers to Biologics Access

 As we think more specifically about these inflammatory diseases, we know there’s a lot of medication classes, from anti-TNFs [tumor necrosis factor] to IL-17s, IL-23s, to JAK [Janus kinase] inhibitors. Dr Kayal, you’re really an expert in this space. Could you provide an overview of the biologic use in inflammatory diseases? Maybe focus on one of the upcoming biosimilars [for] adalimumab because I know we’re all awaiting that as well.

: That’s a great question, and I’m so excited because I think now more than ever, we have a lot of great therapeutic options that we didn’t even have a couple of years ago. It’s a great time to practice in this field because we do have some great options.

As you said, we have the anti-TNF agents. These include infliximab, adalimumab, and certolizumab. We have the anti–[IL-]12/23 agent, which is ustekinumab. More recently, we’ve had the approval of the anti–IL-23 agent, which is risankizumab. We have anti-integrin therapies in inflammatory bowel disease specifically, which include vedolizumab, and it’s something that we use quite frequently for our patients with colitis and [Crohn] disease. In the last couple of years, we’ve seen the rise of small molecules like JAK inhibitors, starting with tofacitinib, which is a pan-selective JAK inhibitor, and most recently, upadacitinib, which is a JAK-1 selective agent.

It's interesting because I get the question asked a lot: Which drug for which patient at which time? The answer is there’s no one-size-fits-all. Choosing the therapy is really dependent on the patient and their risk factors, but even more importantly, we think a lot about…disease severity and…disease acuity and essentially how sick are they right now and what is the potential for them to get sicker over the long term? We think about their present illness, and then we think about their risk of progression [vs] their chronic illness essentially. Using those tidbits, you start to develop a therapeutic plan for your patient.

What’s really interesting and exciting is that, as you mentioned,…just this year alone we’ve seen the approval of multiple adalimumab biosimilars, which is really exciting because what we hope these biosimilars will…make it easier for us to treat our patients and get more drugs into patient hands in a more efficient and cost-effective way.

 You did a great job talking about the continuum of care because we’re not just looking at these disease states in a one-time treatment or if it’s a one-time cycle. A lot of times, we’re looking at control over that time period, and patients through their progression of disease may go through different classes that you really outlined.

Maia Kayal, MD, MS, provides an overview of the biologics used in inflammatory diseases.