Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, gives an overview of what practices and health systems need to prepare for as more interchangeable biosimilars enter the US market.

How do you think interchangeability will play into future decisions regarding formulary placement of biosimilars?

Interchangeability is a hot topic. We already have our first [interchangeable] insulin [biosimilar]. I saw it first it at The Center for Biosimilars

 when that news came out, and I think we're gonna see it in a lot more areas and so that gives pharmacy a lot more of that responsibility to change out the products as needed. I will say we've worked already to create a formulary P&T [pharmacy and thearapeutics] approval where we can exchange biosimilars as needed, based on payer preferences, based on organizational preferences, and that's worked out really well. But I think as you see interchangeability, you might see a little bit of leveraging those products that have better interchangeability come up forward a little more, because we can have better control, ultimately, of what we're dispensing to patients. And again, when you have better control and you have the potential to interchange, you just have to make sure you're doing it on label. So, it's little complex. I think we figured it out from a from a P&T perspective, but I do think it'll start to play more of a role as we preference and try to splice out the differences between therapies.

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Ryan Haumschild, PharmD, Advises Practices, Health Systems to Prep for Interchangeable Biosimilars

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 May 30, 2022.

Number 5: With multiple adalimumab biosimilars poised to enter the market and more biosimilars in more disease states seeking interchangeability, the US market is entering 

Number 4: As drug companies continue to follow the growing trend adopting more 

 and socially conscious frameworks, many are choosing to highlight their biosimilar portfolios as an example of their efforts.

Number 3: A study assessing the impact of 

 in British Columbia on patients with rheumatic conditions receiving infliximab therapy found that switching to a biosimilar did not result in increased health service use.

Number 2: Alvotech released new data demonstrating the equivalence of its 

 (AVT04) to the reference product (Stelara) in patients with plaque psoriasis.

Number 1: The European Committee for Medicinal Products (CHMP) 

rejected Prestige Biopharma’s biosimilar

 referencing Herceptin; Prime Therapeutics’ plan to leverage biosimilars resulted in savings for patients; Samsung Biologics and AstraZeneca liquidated their joint venture (Archigen Biotech).

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of May 30

Combatting misinformation surrounding interchangeability and incentivizing biosimilars are just some of the many things that can be done to ensure patients benefit from biosimilars savings, said Julie M. Reed, the executive director of the Biosimilars Forum.

What needs to be done to ensure that patients benefit from biosimilar savings?

So, market barriers and access need to be improved. And as I mentioned, it's coverage on formularies, it's access through PBMs [pharmacy benefit managers] not just to 1 biosimilar but to multiple. That will get us robust competition, robust price decreases, and robust cost savings. 

Changing policies that disincentivize and don't provide a level playing field.
So, having Medicare look at Medicare Part D, and consider ASP [average sales price] plus 8%, which is technical. But it means that the provider will have a level playing field against the reference product because they're not incentivized to use a lower-cost biosimilar given the current way the policy is written.

We've looked at and what we have experienced, because our members are global multinational companies, they've done biosimilars around the world, and we know that shared savings programs work. And we see those in the United Kingdom as well as other places in Europe. 

So, we encourage CMS to consider a shared savings program both sharing the savings with the physician to use biosimilars, but also sharing savings with co-pay reductions for Medicare beneficiaries. The money that we save using a biosimilar should also go back to the patient and into their pocket, which is the whole meaning behind this. So, there's that piece, market access.

Second thing to continue to improve biosimilars, which we're very active right now, is to make sure we have a robust FDA. So, BsUFA [Biosimilar User Fee Amendment] 3 is critical. It funds the FDA and funds the development programs that are underway. We're excited about the [Biden administration's] commitment letter, and we were a key part of the negotiations. The way the BsUFA 3 is written is, I think one of the key components, is the regulatory science workshops that'll happen. That is perfect timing. 

We have 10 years of experience with our member companies doing global development  and in the United States and 10 years that the FDA's experienced developing and approving biosimilars. We can take all of that knowledge into the regulatory science workshops and work with the agency to scientifically evolve the approval program of a biosimilar. And what we're excited about and where we'll work very closely with the FDA is, what is the scientific components needed to approve a biosimilar today and in 15 years and 20 years vs 10 years ago. So, I think that'll be great.

Another big piece is this is a critical year, I was reading a paper this morning to remind myself, you know, IQVIA predicts we will have savings of $133 billion for biosimilars by 2025. That's 2 years basically from now considering the time warp we're all in, we're into 2023. But we have a long way to go and a lot of that savings is going to come from the competition of biosimilars for Humira [reference adalimumab] and that's why I think also it's such a critical year.

And one of the key pillars where we've been working on even more is education and combating misinformation. We're seeing misinformation about interchangeable vs non interchangeable biosimilars. That's critical with the 7 Humira [biosimilars] launching next year, all interchangeable or non-interchangeable, a biosimilar approved either way is a biosimilar and it's approved to have the same safety, quality, and efficacy as every other biosimilar. 

It doesn't matter if you're interchangeable or not. That's key because that is something we don't want to hear or see is that a physician or a patient or stakeholder thinks that an interchangeable biosimilar is safer or higher quality or has better data with it. That's not true. And the FDA is going to help us with that through our education programs.

Interchangeability is only meaningful if the product is going to be dispensed by a pharmacist without a physician interaction. So, that's something we are anticipating, to have misinformation, and the agency is alerted. As we continue to educate they're going to work with us to educate on that. We're also going to continue one of the key things the Forum does is look for misinformation. And we work closely with the FDA and FTC [Federal Trade Commission] because it's our job as industry to make sure patients and physicians and stakeholders have competence. And so, we can't let up on not reporting these cases.

Julie Reed Catalogues Actions Needed to Ensure Biosimilars Benefit Patients

Here are the top 5 biosimilar articles for the week of May 23, 2022.

Number 5: Authors of a new study demonstrated that 

 between infliximab biosimilars CT-P13 and SB2 and the reference product (Remicade) were safe and effective in patients with inflammatory bowel disease (IBD).

Number 3: Jeff Patton, MD, CEO and board member at OneOncology, dived into the 

 that pharmacy benefit managers (PBMs) play in formulary decision-making and how PBMs impact biosimilar utilization.

 of their bevacizumab product, Abevmy, a biosimilar to Avastin, on the Canadian market.

, as JSR Life Sciences launches its business division (Similis Bio) that will improve efficiency and costs related to biosimilar development and Biocon Biologics signs a contract for commercialization in Malaysia.

The Top 5 Biosimilar Articles for the Week of May 23

The use of bevacizumab products for ophthalmic conditions will continue to evolve as the market grows. However, off-label usage will likely be the norm, according to Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health, at Asembia’s Specialty Pharmacy Summit.

Do you think that the potential for more bevacizumab biosimilars coupled with the recent 

 of Alymsys will encourage more companies to seek indication expansions for ophthalmic conditions?

The role of bevacizumab in ophthalmology use is likely to continue to evolve. So, today you have off-label Avastin [reference bevacizumab] being used as one of the most common anti-VEGF [vascular endothelial growth factor] treatment options for retina conditions. However, we now have Avastin or bevacizumab biosimilars, but these are primarily being used in oncology indications. But the reason why this is going to continue to evolve is you also have Outlook Therapeutics with a bevacizumab candidate [Lytenava; ONS-5010; bevacizumab-vikg] that is 

So, these dynamics are going to shift the types of use for the product and the treatment plan when evaluating treatment options for retina conditions. But not only do you have the bevacizumab scenario and dynamics going on, you also have increasing market entrance of additional innovative treatment options for ophthalmology. And I really believe these past couple years and a couple of years moving forward is a very innovative time period for ophthalmology treatment options. We have new treatment options, from port delivery systems to novel mechanisms of actions, coming into market and competing both with originator biologics and biosimilars.

So, I don't particularly foresee that bevacizumab biosimilars are going to start competing or seeking additional indications in ophthalmology, especially because the originator product does not have it as an on-label indication. However, I think the use of the product is going to continue to evolve as these market dynamics evolve.

Dr Sonia Oskouei Predicts How Bevacizumab Use Will Evolve in Ophthalmology

Here are the top 5 biosimilar articles for the week of May 16, 2022.

Number 5: Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting examined the 

 of biosimilar utilization and the impact of products that have been reclassified as biologics on Medicaid spending.

Number 4: A new bill that would amend the Federal Food, Drug, and Cosmetic Act aims to expand FDA 

 for prescription drugs and medical devices, including biosimilars and generics.

Number 3: Biocon’s total revenue for the fourth quarter of the 2022 fiscal year was up 21% from the same period in the prior year, largely due to 

 in sales for the company’s biosimilar and generic drugs.

 Teva Pharmaceutical’s biosimilar (Ongavia), which references Lucentis (ranibizumab), for the treatment of several ophthalmic conditions.

Number 1: In a pharmacokinetic study, Alvotech’s 

 referencing Stelara was shown to have comparable safety and efficacy to the reference product, according to the company’s preliminary results.

The Top 5 Biosimilar Articles for the Week of May 16

Altering reimbursement procedures needs to become a bigger priority for government officials to incentivize biosimilar utilization, according to Eric Tichy, PharmD, MBA, vice chair of pharmacy formulary at the Mayo Clinic Health System.

What more should state and federal governments do to ensure that patients have access to biosimilars?

 [that governments should be doing] is making sure the reimbursement incentives are set up the right way where it is actually beneficial for all the different participants to use the biosimilar. The patients themselves, a lot of times they don't see much of a benefit because of the way the benefit design is set up. So, I think making sure the incentives are aligned is very important, and that's one of the areas where you do get some resistance. Making sure the provider, the payer, and the patient all have the incentive to use biosimilars. That's what will make it work really well and increase our access and uptick.

Dr Eric Tichy Calls for Government Officials to Realign Incentives in Favor of Biosimilars

Julie M. Reed, the executive director of the Biosimilars Forum, discussed how biosimilar savings can differ between stakeholders and the importance of competition for creating those savings.

How do the potential savings related to increased biosimilar utilization differ for health plans and patients?

That's a great question. I think it differs only in who the stakeholder is. The cost savings are there for everyone. Now, what really differs is the responsibility of the health plans. They can and should include all biosimilars on their formularies, and they should cover all biosimilars, and that gives patients and doctors access to all the biosimilars.

That's really key because what we know and our economic studies show is that the more biosimilars competing at the same time with the reference product, you're seeing the prices go down faster, you're seeing greater cost savings. If it's only 1 biosimilar vs all the biosimilars and having equal access and coverage, you're not seeing the robust competition that you could be having. That, in turn, [leads to] the price goes down, the co-pays go down, the prices for patients and everything else.

So, that's a key piece as far as the payers and their formularies, and Medicare, and the governments. They have a responsibility to really promote and increase the uptake to these lower-cost products.

Julie M. Reed, the executive director of the Biosimilars Forum, discusses how biosimilar savings can differ between stakeholders and the importance of competition for creating those savings.

Julie Reed Talks About How Savings Can Differ Between Patients, Health Plans

Amy Valley, vice president of clinical strategy and technology solutions at Cardinal Health, details the company's Decision Pathway, a health information technology (IT) tool that can assist practices with prescribing patients the lowest-cost product, including biosimilars.

Can you describe Cardinal Health’s Decision Path and explain how the technology works?

Yes, so Decision Path is the latest addition to our Navista TS platform, which is really designed to help oncology practices be successful at value-based care. I think everybody's acutely aware that the oncology care model is ending, which has been the CMS' demonstration model over the past 6 years. We don't know exactly what's coming next but we're certain that there will be successor programs.

In the meantime, many of our practices have gone on to develop their own types of value-based agreements and incentive programs with the commercial payers in their region. So, even those practices who are waiting for what's coming next in CMS, they're going forward and continuing to enhance their care coordination programs and all of the other investments they've made in care transformation so that they can be successful as this journey from fee-for-service to value-based reimbursement continues.

Does the tool specifically focus on drugs under the medical benefit, or can this work in the pharmacy benefit setting as well?

Yes, it includes both, actually. Our financial tools within Cardinal Health's specialty have always been rather unique in that as we approached the market, we were very focused on having a more holistic view of treatment costs. That includes both infused, reimbursable drugs for the medical benefit as well as the pharmacy benefit. And so, we follow the same methodology with Decision Path. So, you're able to see costs of oral and injectable or infusible drugs.

Does the tool identify treatment options based on payer formulary lists or does the tool prioritize the least expensive alternative, such as a biosimilar, automatically, regardless of formulary placement?

 We also are able to show the ability or the impact of swapping out biosimilars. That's a very key component and something that is still of avid interest. Although, our recent work here at Cardinal Health and looking at biosimilar adoption is showing that in oncology, it's just not new territory anymore to be thinking about that in terms of the biosimilar. It's probably getting a little more complex because we have the luxury now with some [reference products] with multiple biosimilars. That's where we think that the value will be as competition in that market and prices, cost, and patient support services are evolving to help providers get a little bit of a better handle on that in an easier, more efficient way.

How does the technology take into account rebates and reimbursements on drugs when helping providers make treatment-based decisions?

 So, we're able to pull that information into the net cost of drug therapies. And so, that really gets more at the providers' level costing more so than the patient's level costing for some of those areas. But we've always had the ability in all of our tool sets for providers and administrative and business personnel within the practice to understand net cost of drugs with and without GPO [group purchasing organization] rebates factored in, and that'll continue to be an element in all of our financial tools. Within Decision Path, since we're mostly focused on total cost of therapy and patient out-of-pocket costs, those GPO rebates and discounts aren't as much of a factor.

How would this tool take into account interchangeable products? Would biosimilars with interchangeable designations get a higher priority over others?

 We haven't really thought through that piece of it yet. I think, at this point, with interchangeability being at its current state, we don't have as much of a need to have that automated within the tool at this point. But again, with our strength in biosimilars, it's certainly something that our VP [vice president] of biosimilars is supporting our team regularly to think through the when and how of how we'll be able to service those insights.

How can technology be updated to include new therapies and indications as they’re approved? Will the updates have to be entered manually or will there be regular system-wide updates?

 There will be regular system wide updates. That's our current practice today. We don't really wait always for the new regimens to be entered into the system until NCCA has had time to update. Although, I think they're getting faster and faster at their updates. But sometimes a new therapy is approved and we want to be able to have that in there right away. And so, we do have sort of a supplement, if you will, until things are reflected in the NCCN guidelines. But that's something that we do on a regular basis and those will be automatically updated within the system.

Does the tool also take into account any drugs that are often used off-label?

 [It does] in the same manner that NCCN would think of those. There are many drugs throughout the NCCN guidelines that aren't necessarily officially indicated from an FDA labeling standpoint but have compendial listings and, of course, with NCCN being a compendial listing. So, I think the definitions for that has already been developed in our regular business and so we would continue to follow those.

Health IT for Biosimilars Spotlight: Cardinal Health's Decision Pathway

Although the United States is looking to be one of the first countries to market an ophthalmology biosimilar, more education is needed to convince ophthalmologists of the safety and efficacy of biosimilars, said Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health, at Asembia’s Specialty Pharmacy Summit. 

According to Cardinal Health’s 2022 report, only 40% of ophthalmologists reported being “very familiar” with biosimilars. What needs to be included in educational material aimed at these specialists specifically to increase that statistic?

Ophthalmology market research and our own market research at Cardinal Health has really revealed hesitation when it comes to biosimilars at this stage. In fact, when we looked at trends earlier when the first biosimilar was approved and launched in oncology, believe it or not, there were similar perceptions associated biosimilars amongst oncologists. Now, you see the strong adoption that we have an oncology today.

As we're entering these new therapeutic areas, with ophthalmology being the latest, we are seeing this hesitation and lack of familiarity, where there's a desire for more information and the need for more information to help build clinical confidence in these agents. So, any type of data or evidence in understanding of the FDA approval pathway and the associated scientific rigor from the FDA is key to helping build clinical confidence.

I will say in ophthalmology it's almost trickier because unlike oncology and rheumatology, there is not this robust international experience in ophthalmology with ophthalmology biosimilars. In fact, the US is going to be one of the first countries to have an ophthalmology biosimilar available. So, we are positioned to be a source of generating real-world evidence and data to support future confidence in these agents as more products are anticipated to come in the retina space.

Although the United States is looking to be one of the first countries to market an ophthalmology biosimilar, more education is needed to convince ophthalmologists of the safety and efficacy of biosimilars, said Cardinal Health's Sonia T. Oskouei, PharmD, BCMAS, DPLA.