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

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

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

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

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

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

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

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

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 May 1st, 2023.

Number 5: Samsung Bioepis shared positive 1-year results from a phase 3 trial 

 between the company’s aflibercept biosimilar and the originator (Eylea) at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting.

Number 4: In April, biosimilars to treat rheumatic conditions had some progress, as well as some setbacks, and 

 that switching from originators to biosimilars is safe and effective but warned about the nocebo effect.

, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

Number 2: Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar 

 responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.

Number 1: Sarfaraz K. Niazi, PhD, dove into 

 may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.

To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of May 1, 2023. 

The Top 5 Biosimilar Articles for the Week of May 1

Hi, I’m Skylar Jeremias 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 April 24, 2023.

Number 5: A study assessing factors that may determine a commercial health plan’s likelihood of covering a biosimilar found that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have 

Number 4: Celltrion Healthcare shared data from a phase 3 clinical trial confirming that its omalizumab biosimilar had 

Number 3: A retrospective study in Scotland found that 

 from originator infliximab to biosimilars seem to be safe and effective in patients with inflammatory bowel disease (IBD), irrespective of the number of switches.

 (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.

Number 1: The misconceptions about disposable bioreactors' lifecycle are gone; the era of hard-piped, giant, stainless-steel tanks for biosimilar development is history now, according to Sarfaraz K. Niazi, PhD, in his 

The Top 5 Biosimilar Articles for the Week of April 24

The prospect for on-body pegfilgrastim biosimilars is one of the most exciting things coming down the pipeline in the supportive cancer space, said Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health.

What are some strategies that clinics and pharmacists can implement to increase biosimilar uptake and realize cost savings?

There are a lot of strategies that clinics and hospitals can utilize for biosimilar uptake. Probably the most important thing is to engage your pharmacy team. As pharmacists, we are your drug experts. We're here for you, we're in your corner, and we really understand the benefits that biosimilars have for not only your clinic, but also your patients as well.

One of the most important things is to start with education. Make sure that everyone on the team understands what a biosimilar is and what it's not. The great thing about them is that the FDA has so many great resources that really lays it out. This is the difference between that and maybe a generic. Are there any issues with things like interchangeability and how you can go about operating those? So, there's a lot of resources there, and there's a ton of publications that have been brought out in the last year that talk about successful programs. And so luckily, you don't have to go at it alone. You just have to make sure that you engage your pharmacy team and really focus on the educational aspect.

Most importantly, you're going to realize a ton of cost savings. That's exactly what biosimilars were brought to the market to do. They were brought in to bend the curve down in terms of our spend in overall oncology care. And the most important thing is that this helps patients and their access to really critical medications. And so, if you're not using biosimilars, I think that's a bigger question of how to best implement them.

How to do you feel about the prospect of more supportive care biosimilars coming to the US market, especially as we move closer to having biosimilar competitors for Neulasta Onpro?

To me, this is one of the most exciting things when I think about the additional competitors that are coming to the market in biosimilar categories, especially when we think about the Onpro device that's been just so dominant in the market for so many years.

This is a patient access issue, right? Some patients don't have that opportunity or it's difficult for them to come back to the clinic multiple days in a row. And that on-body [device], unfortunately, just because of the patents surrounding it, has been able to be dominant in the market and continuously get more and more expensive.

So now that we have new competitors that are coming in the market that are going to have an equivalent device so that patients can receive their Neulasta [pegfilgrastim] on time, safely, without having to return to the clinic is really one of the most exciting prospects I think for the future of oncology care.

We know that when biosimilars come into the market, regardless of the product, they start to drive prices down, and they drive [them] down quickly and significantly. And this is exactly what we need to support as providers, as clinicians, as supportive care services. We need to find ways to make cancer care cheaper, and I can't think of a better opportunity than to have a biosimilar for the on-body [device]. It's going to be a game changer and I'm really excited for it.

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, expressed staunch belief that biosimilars referencing Neulasta Onpro, the on-body injector version of reference pegfilgrastim, are one of the most exciting things coming to the supportive cancer care space.

Dr Andre Harvin Explains His Excitement for Neulasta Onpro Biosimilars

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

Number 5: The Committee for Medicinal Products for Human Use 

 for an eculizumab biosimilar, and a biologic license application for a bevacizumab biosimilar was accepted in Brazil.

Number 4: A retrospective real-world study assessing patient outcomes related to switching from reference rituximab (Rituxan) to a biosimilar version (Truxima) found that transitioning between the products was 

 and did not result in a change in adverse events.

Number 3: Celltrion Healthcare shared data from a phase 3 clinical trial confirming that its omalizumab biosimilar had 

Number 2: In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further 

 for the ninth adalimumab biosimilar until potentially June 2023.

Number 1: The misconceptions about disposable bioreactors' lifecycle are gone; the era of hard-piped, giant, stainless-steel tanks for biosimilar development is history now, 

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

The Top 5 Biosimilar Articles for the Week of April 17

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

Number 5: Celltrion Healthcare shared data from a phase 3 clinical trial confirming that its 

omalizumab biosimilar had comparable safety and efficacy

, neurologists in Europe reported feeling positive about the biosimilars for multiple sclerosis (MS) coming down the pipeline, showing that industry-wide education efforts and experience with biosimilars are working to instill greater confidence in these products.

Number 3: A retrospective study from India found that Razumab, a ranibizumab biosimilar, was 

safe and effective to use in infant patients

 with retinopathy of prematurity. This is the first analysis assessing the clinical outcomes associated with the biosimilar in this population.

Number 2: STADA Arzneimittel and Xbrane Biopharma 

 of Ximluci, a ranibizumab biosimilar referencing Lucentis approved to treat ophthalmic conditions, across the European Union.

gained another high-concentration adalimumab biosimilar

 with the approval of Sandoz’ Hyrimoz HCF and the FDA accepted a biologics license application for a trastuzumab biosimilar (HLX02).

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

The Top 5 Biosimilar Articles for the Week of April 10

The United States is going to have to wait and see whether adalimumab biosimilars will have sufficient uptake, and hopefully, they won't experience the adoption challenges observed in the diabetes space, according to Christine Baeder, the new chair of the Association for Accessible Medicines (AAM) and chief operating officer for US generics and biosimilars at Teva Pharmaceuticals USA.  

With the reauthorizations of the Biosimilar User Fee Act (BsUFA) and Generic Drug User Fee Act (GDUFA), the Inflation Reduction Act, and the US market introduction of adalimumab biosimilars, how do you see the generic and biosimilar industries developing over the next few years?

There's a lot of exciting possibilities. That's the good news. The bad news is if we don't take some action, and work together between regulators, legislators, and manufacturers, I don't know that patients are going to feel the benefit of that. So, GDUFA specifically, we made a lot of movement towards lifetime communication, and faster approval cycle. We could go farther, but we're happy that we made the progress we made.

The ideal state would be that the FDA very much partners in live time with manufacturers to get those drugs approved, especially first-to-market and complex generics. There tends to be sort of fits and starts; you submit a package of data, the FDA takes a few months to review it, you then get a letter back, you take a few months to review it, that goes back. Imagine a system where we can line everything up, and things move faster, and then we get to approvals faster. That’s, I think, everyone's ideal state, we're working towards getting there.

So, we made some progress on GDUFA, that's exciting. Adalimumab? We'll see what happens, right? I read the news, just like you do, and there's a lot of concern that we won't have the biosimilar uptake as quickly as we would like to have it. I also see that as an opportunity. So, if that does happen, what are we going to do from a policy and regulatory perspective to make sure we do better going forward? And how do we correct it? And how do we talk about incentives in a different way? So, it's all so exciting and full of possibility, it's just not clear to me what the answer is yet.

Eli Lilly just announced that it will significantly reduce the prices of their insulin products—including its recently launched insulin glargine biosimilar—and capping patient out-of-pocket costs to $35, in line with the Medicare Part D provision set out in the Inflation Reduction Act. What was your reaction to this news and do you think this could have an impact on insulin prices as a whole and the utilization of insulin biosimilars?

Insulin has been a challenging market for patients to feel any reduction in cost for a long time. So, I think everyone welcomes a different approach, and I certainly applaud Lilly for the for the actions that they've taken. I think it does beg a question; if you look at the insulin market and you look at Semglee [insulin glargine biosimilar] on how the incentives are structured and what's going on that you're not seeing the uptake of the biosimilars the way we would want to.

I'm very much watching Amgen, which just launched the first biosimilar to Humira [

], and if you notice, they also had a high-whack and a low-whack strategy, much like we saw with 

 in the insulin space. So, if that continues to happen, you have to wonder why that's happening; why the lower-priced item isn't moving and we're not getting the uptake. I think that is raising a lot of questions and driving a lot of conversation, and we're talking about it in a way that we haven't talked about it. So, it's exciting to me that maybe that's the start of some new set of incentives or a new structure that helps us get those savings all the way through to the patient.

Upon coming into her position as the new chair of the Association for Accessible Medicines (AAM), Christine Baeder discussed what she believes the future holds for biosimilars, good and bad, and the questions that still surround the insulin price cap.

Christine Baeder Discusses the Future of the Biosimilar Industry, Insulins

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

 for the Biosimilar User Fee Act (BsUFA) meetings and how they influence the efficiency of the biosimilar approval process in the latest installment of his bimonthly column.

 to implement a biosimilar switching policy, following in the footsteps of Ontario and 7 other jurisdictions.

Number 3: Yukon, 1 of 3 Canadian territories, announced that it will implement a 

, following Newfoundland and Labrador’s announcement to move forward with a similar policy earlier this week.

 its insulin glargine biosimilar, Rezvoglar (insulin glargine-aglr), on the US market, making it the second interchangeable insulin biosimilar to become commercially available to American patients with diabetes.

Number 1: The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to 

establish a demonstration project within Medicare

 that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.

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

The Top 5 Biosimilar Articles for the Week of April 3

Here are the top 5 biosimilar articles for the week of March 27, 2023.

Number 5: In the wake of adalimumab biosimilars hitting the US market, Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health, hyped up the current biosimilar market trends and the other products 

 during her talk at the Festival of Biologics.

Number 4: At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on 

, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.

Number 3: At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a 

 comparing its ustekinumab biosimilars (SB17) with the reference product (Stelara).

Number 2: At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum, warned that without changes to encourage biosimilar uptake, companies will begin to ask the 

 its citrate-free, high-concentration formulation of its adalimumab biosimilar, Hyrimoz.

The Top 5 Biosimilar Articles for the Week of March 27

Christine Baeder, the new chair of the AAM and chief operating officer for US generics and biosimilars at Teva Pharmaceuticals USA, talks about what’s first on the list in her new role, as well as the challenges that she expects to encounter and her plan of action.

What are the main goals and initiatives that you want to prioritize in your new role as AAM chair?

Certainly, my most important role is raising awareness of the generic industry, and the fact that, I think, we're approaching a crisis of sustainability. We're already starting to see some manufacturers leave the market for financial reasons, as well as less investment in new products. I think it's time that we all come together and speak with one voice and make sure that we remember that generics are a US success story. The legislators, the regulators, and the third-party industry works together and created this amazing thing, which is generic pharmaceuticals, which is something now that we all count on as the backbone of our health care system. Over 90% of prescriptions, less than 20% of the cost, by every definition, that's a success story, and it touches every family in the country. I don't think there's anybody who hasn't taken a generic drug at some point in time. So, it's important that we continue to foster and support that industry going forward.

What challenges in the biosimilar and generic spaces are you looking to tackle first and how do you plan to address them?

The first one is to try to talk about anything that doesn't support the additional sustainability of generics and the biosimilar space. We'll talk about them separately; they have somewhat different issues. The generic industry has been working for a very long time, and over time, what's happened is there has been the erosion of the incentives that make the system work really well. When I started in generics, when a generic product was launched, you would get to 80% utilization of generics within a very short period of time, let's call it 6 months. What we've seen is that innovative companies have been very successful as of late in having strategies that maintain their market share for a longer period of time, and those are things that just don't make sense to me. So that's one of the things that we would be tackling. We would support a legislative solution that says, if it's a generic medication, it’s offered on a generic tier for patients.

I think one of the challenges in discussing the generic industry is that people's perception is that the price of medication is too high. Generic medications are not expensive. The average copay for a generic medication is $6. So, there's something going on in the system that doesn't allow people to feel the benefit and the value that generic products bring. So, I would be fully supportive of a review of the value chain. I support pharmacists getting compensated for the work that they do; speaking to a patient, that can take a lot of time, people have a lot of questions and pharmacists are very trusted. And they're accessible. You can go into your pharmacy and talk to someone; you can’t always just drop by your doctor's office. So, I fully support that. And I recognize the value that the wholesalers bring in moving product from place to place, especially cold chain products, that's not easy to ensure that it's delivered within the temperature conditions that's required to make the medication work as it's supposed to. 

So, I'm not against other people in the value chain getting recognized for the value that they bring. But we do need to ensure that the savings that we create by bringing multiple generics to the market also impact the patient at the pharmacy counter, and that people are feeling the erosion of the price that's associated with market competition. Sometimes that doesn't happen, and why is a super complicated question. For sure, that's something that I would support looking into and trying to figure out how we can do better.

Biosimilars are a bit different, right? We don't have the built-in incentives that we have on the generic space. If you go back 20 or 30 years, I know I got trained on what's a generic when I went to the pharmacy counter, and they're like, “well, you can get this drug for $5. Or you can get the same drug in a different box and it's $40,” which creates just an inherent incentive at the patient level. And then that patient helps create that incentive at the health care practitioner level. They're like, “hey, I want the cheaper one, can I get the cheaper one?” We don't have that yet for biosimilars.

Biosimilars are actually approved as brands. So, all of the mechanisms at the state level and different legislation over the years that creates that national incentive for generics to be a more affordable option, don't exist in the same way yet for biosimilars. I would certainly encourage that we continue to look at, what do we need to do to create an incentive down to the patient level for biosimilar utilization? In addition, if you go up one more step to health care practitioners, there's really not an incentive there either because the patient isn't saying, “hey, that's cheaper,” the patient’s saying “well, I can get this the same one I've always got at the same price. So why wouldn't I just do that?” And the doctor has to do nothing to do what he or she has always done, as opposed to learn the names of 10 other new drugs and remember which one is which one he wants to give, which is a heavier lift than just doing nothing. So, we need to create incentives at every piece of the value chain to help biosimilars be successful.

Upon coming into her position as the new chair of the Association for Accessible Medicines (AAM) as well as chief operating officer for US generics and biosimilars at Teva Pharmaceuticals USA, Christine Baeder discusses her primary goals in this position, and the challenges that accompany them.