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BIOSIMILAR APPROVALS

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Articles

Italian study finds most MS patients start biosimilars unaware, exposing education gaps and highlighting MS nurses as key to boosting trust and uptake.

Low Biosimilar Awareness in MS Patients Points to Critical Gap in Nurse-Led Education

New EULAR guidelines speed RA treatment switches as rheumatoid arthritis biosimilars and cost savings push earlier biologics use.

Biosimilar Expansion, Lower Costs Drive Shift in RA Treatment Guidelines

Dr. Cyrus Karkaria is President of Lupin's Biotechnology Businesses, leading the company's global biosimilars portfolio with over 30 years of biologic drug development experience at organizations including Biogen, CuraGen, and Celldex Therapeutics. He holds a post-doctorate from Harvard Medical School and a PhD. from the University of Maryland.

The FDA has approved ranibizumab-hkdz (Ranluspec; Lupin Limited) as an interchangeable biosimilar for wet AMD, DME, DR, RVO, and mCNV.

FDA Approves Ranibizumab-hkdz as First Interchangeable, Available in Both Vials and Prefilled Syringes

Evidence shows biosimilars switching in ankylosing spondylitis maintains disease control with biologics, cuts costs, and highlights nocebo risks.

Biosimilar Switching Maintained Disease Control in People With Ankylosing Spondylitis

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Clinical

On March 23, 2020, the transition under the Biologics Price Competition and Innovation Act (BPCIA) was complete, allowing products formerly classified as “small-molecule” drugs, including all insulin products, to be approved under the biologics regulatory pathway. This week on the podcast, we’re speaking with Cate Lockhart, executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how this transition will affect the pace at which biologics come to market.

This week on the podcast, we’re speaking with the executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), Cate Lockhart, PharmD, PhD, about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how the new approval pathway for biologics will affect the pace at which biosimilars come to market.

"Not So Different": How the BPCIA Transition Will Affect Biosimilar Uptake

Scoping review shows clinicians and patients still worry about biosimilar insulin switching, devices and safety—evidence gaps shape insulin product swaps.

Gaps in Knowledge Persist Around Biosimilar Insulin Switching, Review Finds

Explore the complexities of insulin biosimilars, their safety, and the impact on diabetes management in global health systems.

Perceptions Still Play a Central Role in Biosimilar Insulin Switching

Biosimilar QL1207 Demonstrates Equivalent Efficacy and Safety in DME

Biosimilar insulin glargine struggles for market share in the UK, facing pricing challenges and prescriber inertia despite regulatory support and cost-saving potential.

Low Prices Fail to Boost Insulin Biosimilar Uptake in the UK

The dulaglutide biosimilar LY05008 demonstrated equivalent efficacy in reducing HbA1c, along with comparable safety and immunogenicity profiles, to the reference drug dulaglutide in Chinese adults with type 2 diabetes.

Dulaglutide Biosimilar LY05008 Shows Efficacy and Safety in Treating Type 2 Diabetes

Insights From Cencora's Lakesha Farmer: Innovative Biosimilar Adoption Strategies

Lakesha Farmer, PharmD, MBA, senior director, strategic accounts, ION Oncology Practice Network at Cencora, explains new strategies being used to incentivize biosimilar adoption and market competition in a world where reimbursement and rebate policies cater more towards innovator products.

Can you discuss any innovative pricing and reimbursement models that have been implemented to incentivize biosimilar adoption and market competitiveness?

Sure, since the introduction to the market, we've seen some very unique pricing incidences strategies created to incentivize adoption of biosimilar agents. So, most recently, we've seen manufacturers take a nonbranded and branded approach to the launch of their biosimilars, which offers a low wholesale acquisition costs are WAC and the high WAC option. This pricing approach is currently being seen with insulin biosimilars and adalimumab biosimilars.

For example, the adaIimumab biosimilars Cyltezo was initially launched as a branded, high WAC product that offer about 5% discount to the originator (Humira). The makers of Cyltezo saw that the uptake of the medication was pretty slow, and that not all PBMs [pharmacy benefit managers] and insurers were receptive to adding the slightly discounted medication to their formularies. So, about 3 months after their launch, the manufacturer decided to launch an unbranded, low WAC version of the medication, which was surprisingly about 81% less than the originator product's price. So, by taking this low WAC/high WAC approach to pricing, this caters to all PBMs and issuer plans based upon their preference and increases coverage and access to biosimilar for patients.
The only possible downside to this pricing strategy that I can possibly foresee is that the heavily discounted low WAC options could possibly impact a manufacturer's ability to offer co-pay assistance programs and other patient access resources.

The second unique pricing strategy that incentivizes patients access to biosimilars is the Mark Cuban Cost Plus Program. This program aims to lower patient out-of-pocket costs by offering your Yusimry, an adalimumab biosimilar, to patients for a low cost of $569 [per month]. According to Drugs.com, the average cash price for Humira is about $7,300. As you can see, by offering this biosimilar at a cash price of $569 to uninsured patients, as well as a possible option for commercially insured patients with high deductibles, co-pays, and/or co-insurances can definitely be a game changer.

Now moving on to address the unique reimbursement incentive. Currently, the most notable incentive is the add-on payment for physician administered biosimilars that was introduced under the Inflation Reduction Act. Under this provision biosimilar reimbursement is set at ASP [average sales price] plus 8% of the reference product's ASP, which is higher than the reference product's reimbursement, which is set at ASP plus 6%. This higher reimbursement rate, provided through Medicare, provides community based providers with a greater incentive to use biosimilars for their patients.

Videos

Lakesha Farmer, PharmD, MBA, from Cencora discusses innovative pricing and reimbursement models incentivizing biosimilar adoption and competitiveness, including dual pricing strategies and the Mark Cuban Cost Plus Program, while highlighting potential impacts on patient assistance programs.

Insights From Cencora's Dr Lakesha Farmer: Innovative Biosimilar Adoption Strategies

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

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.

Conference

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

CfB: I'm Tony Hagen with The Center for Biosimilars. Today, we're speaking with Sean McGowan. He's the senior director of Biosimilars for AmerisourceBergen. Welcome, Sean.

CfB: Sean, can you comment about biosimilar approvals in 2021? It was a pretty interesting year, I think, even though we had just a few.

McGowan: Yeah, it was it was quite a year of firsts for biosimilars in 2021. And in starting with the biggest approval and launch onto the market with the Semglee [insulin glargine] product from Mylan/Viatris. In July of 2021, the FDA approved the first ever interchangeable biosimilar product in Semglee, an insulin product indicated for treatment for type 1 and type 2 diabetes. That product launched in November with actually 2 versions of branded and an unbranded version. So, Semglee's entrance into the retail pharmacy, including mail order pharmacy, space makes it the first biosimilar to be covered under patients’ pharmacy benefit or Part D plans. So, kind of a first of its kind.

And the interesting thing about the Semglee launch is that it's got the potential to positively impact millions of more patients with its availability at the pharmacy counter. And this is definitely going to be a preview of what's to come with the future of Part D biosimilar launches. Not to mention that Semglee has been recently adopted on to a couple of national PBM [pharmacy benefit manager] formularies, including Express Scripts and Prime Therapeutics.

As we look into other therapeutic areas in 2021, we also saw the first biosimilar approval in the retina-ophthalmology space with Biogen's Byooviz, which references Lucentis [originator ranibizumab]. In October, we saw the FDA approved Cyltezo, making it the first interchangeable biosimilar product referencing Humira [originator adalimumab] and only the second interchangeable product ever to be approved by the FDA. And just to clarify, Cyltezo already had FDA approval. It was that interchangeable designation that received approval back in October.

Then in late December, right before the end of the year, the FDA approved 2 other biosimilars: an insulin glargine product from Lilly and then Yusimry, a biosimilar referencing Humira from Coherus [Biosciences]. So, all of these approvals and entrances in 2021 indicate to me that the FDA is getting back on track to reviewing and approving these products so patients can access these treatments. Also, it's an indication that the market continues to expand.

CfB: Just a footnote to that introduction. The Semglee launch was both a branded and unbranded. Can you shed any light on why that strategy was chosen by Biocon?

McGowan: Yeah, so Mylan and Viatris are the commercial partners and US Biocon is the manufacturing partner and from what I can see and what's been published publicly is that there's actually a non-biosimilar version of Semglee already on the market that had launched back in [the] summer of 2020. And that product came out on the market with a heavily discounted WAC [wholesale acquisition cost] price and looked to be launched to compete more in the Medicare Part D and Medicaid space or those cash paying patients. And then as the biosimilar products were being approved, Mylan/Viatris was looking to compete both in the commercial space as well as that Medicare/Medicaid space. And so, they've kind of launched the same product under 2 different names, 1 branded and 1 un-branded to fit specifically into some specific payer markets. And so, we're less than a quarter into the launch of this product and time will tell on how that strategy actually plays out.

CfB: Thanks. So, at the GRxBiosims meeting, which is a fairly informative conference, there were several FDA representatives speaking and they seemed a lot more focused on biosimilars than they had been in the past. Coming out of the pandemic, or at least, maybe partway through the pandemic, what does this signify, do you think?

McGowan: Yeah, it was great to see the quality and safety of generic and biosimilar medicines was a top priority for our industry and a key theme of the meeting. So, I'd say this progress is motivating and moving in the right direction. The FDA has also promised to provide more clarity on the handling of the interchangeable designation, which I think everyone is really interested to gain some additional clarity and insight into that designation, as we see more and more products receive that designation in the future. It's also encouraging that the pharmacy benefit managers have been moving interchangeable biosimilars onto their preferred formularies like they've done with Semglee and that pharmacists in the retail space now get a chance to experience a biosimilar product. But overall, there's still a lot of basic education required about biosimilars to generate more confidence in their use across all stakeholders in the supply chain.

CfB: So, you have a terrific pipeline report on biosimilars, which is updated regularly. Can you tell us what we can look forward to in biosimilars in the insulin market in 2022?

McGowan: Yeah, sure. So, with 2 approved insulin glargine products, we'll see that market become more and more competitive once Lilly announces the launch timing of their insulin glargine that just recently received approval. We're seeing a product being developed by Sandoz that's currently in phase 3 trials. Last week, we saw an announcement that Biocon's application for its insulin aspart received a CRL [complete response letter] from the FDA but Biocon seemed to be confident that they're going to be able to provide the additional data that's required there. So, we'll see some additional markets either open up or expand in the near future.

We also have another insulin glargine from Lanett that's in the preclinical clinical trial stage. And so, we're expecting, at least based on what they've disclosed, that their clinical trials will start Q1 or Q2 in 2022. And then they're looking for FDA approval in 2023 and a potential launch in 2024.

Finally, there are about 5 rapid-acting insulin biosimilars currently in the pipeline for manufacturers including Biocon, Viatris, Sandoz, and Sanofi. And they're all in different clinical trial stages at this time, from preclinical to phase 3. So, I anticipate more of these insulin products to continue to be developed and hopefully approved and launched onto the US market in the coming years.

CfB: So, this year is shaping up to be a positioning race for adalimumab biosimilar market entry. They don't actually arrive until 2023 but what can you say about the positioning that's going on and how companies are looking to stand out in this market?

McGowan: Yeah, you're absolutely right. 2023 is going to be the year of the Humira biosimilars. And I think we're all anxiously waiting to see how this plays out. And it is going to be 1) very interesting and 2) I think a bit complicated with the number of manufacturers that are already set to launch products in 2023 [n = 7]. And then, how are they going to compete against the existing versions of Humira? So, as far as timing is concerned, Amgen will be first out of the gate with their product launching at the end of January 2023. And they're going to have about a 5-month head start over the next tranche of manufacturers that'll bring their Humira biosimilars to market. So, the next group will have Organon, [Boehringer Ingelheim], and Coherus launch their products in that middle summer timeframe, kind of end of June and early July. Then, we're going to see Viatris, Sandoz, and Pfizer launch their products between August and November in 2023. And then, we also know that Teva, in partnership with Alvotech in the development of that Humira biosimilar, is waiting for FDA approval, but launch timing is really unknown at this point.

CfB: As an aside for the Amgen now, Amgevita [adalimumab biosimilar] will have that 5-month head start. What do you think will be the lasting impact of that advantage?

McGowan: Right now, Amgen definitely is positioned to have the advantage from that timing standpoint and that head start over everybody else. Just a couple of things to take into consideration, you're absolutely right that 2023 is going to be an exciting year, but keep in mind these manufacturers are absolutely focused not only on 2023 but the several years to come after that. And so, 2023 is definitely going to be a year where the staging has taken place. Yeah, there's going to be a bit of an advantage for Amgen, and they're going to have a lot of critical decisions to make around pricing, PBM coverage, support services, patient and physician education, which is all going to have an impact on everybody else that comes after Amgen. So, I think a lot of things are going to play out, but we can't discount the fact that in the years 2024, 2025, and beyond are going to be years where these products are going to be competing. But 2023 is most certainly going to be probably the most exciting, just given the timing and the number of products that are going to come onto the market.

CfB: And 1 more question on the adalimumab pricing. What could be the effects on pricing of having so many competitors arrive on the market at the same time? Do you think that there will be a sudden drop, or do you think that given the settlements that they made with AbbVie [reference adalimumab manufacturer] that that is not going to occur?

McGowan: Yeah, that remains to be seen. I think the pricing piece is going to be interesting, just because they're going to be so many products out there and then you have this long history of AbbVie's pricing on this product. But I think a lot of the activity is going to be driven by the PBMs in which products they decide to adopt, put on their formularies, and switch patients over to. So, it's really going to be incumbent upon the manufacturers to be negotiating those deals with the with the PBMs and then which products are being adopted and which products are left off of formularies. So, at the end of the day, given that this is that pharmacy benefit space, I think the PBMs are going to play a very critical and influential role in the launch of these products.

CfB: Okay, so, etanercept has been a bit of a disappointment in terms of bringing biosimilars to market. The 2 contenders have not succeeded in breaking through the patent barriers on Enbrel [originator etanercept]. So, is there a possibility that other etanercept biosimilar makers will step forward?

McGowan: Yeah, this is certainly disappointing news for the biosimilar market, and it's been an ongoing legal battle across the last several years, especially with 2 FDA approved products out there. But the litigation rulings at this point seem to be pretty definitive. I don't foresee any manufacturers continuing to pick up the torch and continue the legal battle here, which, again, is unfortunate and it doesn't seem like we'll see an Enbrel biosimilar on the market in the US for the next several years.

CfB: In ophthalmology, ranibizumab has taken some interesting turns. Susvimo is a biobetter, some might say, and has an implant reservoir vs an injectable, which could offer great convenience to patients. Could this be a disruptor in the ranibizumab market and how could it affect biosimilar competition?

McGowan: Yeah, it’s a new market and molecule for the biosimilar markets, which is really exciting. So, it's going to be a very interesting market to watch evolve. Not only have we seen this implantable device launch onto the market, we also know that Roche/Genentech is developing their faricimab molecule, which will have retina-ophthalmology indications. So, we'll have to see how successful they will be at launching that product, which will have patents and exclusivities if and when it's approved, and then how successful they'll be in converting patients over to that product. We also have another organization and company with Outlook Therapeutics actually developing a bevacizumab product specifically for the retina-ophthalmology indications. So, that's going to be a little bit of a nuanced wrinkle and addition into an already complex and competitive market.

But on the biosimilar front, there's currently only 1 approved product from Biogen with Byooviz. And we're anticipating at least 3 other biosimilars referencing Lucentis to come onto the market in the next 2 to 3 years. So, Biogen is most certainly going to be the first product on the market in this space and what's been announced is a mid-2022 launch for that product. But it's going to be very interesting to see how the practitioners and the practices get educated on biosimilars, since they most likely have not utilized a biosimilar in the past, and how to build those into their care plans and adopt these products. Given the complexity and how heavily competitive this market is, given the innovator company's position, a new branded product coming to market, and then several biosimilars, it's going to be another very interesting market to watch evolve.

CfB: Yeah, affordability is a tremendous issue in ophthalmology. So, what else might move the needle in the biosimilar pipeline events in 2022?

McGowan: Looking ahead to calendar year 2022, I think there are a few opportunities and challenges to look for. So, going back to Semglee's launch and the availability of 2 versions, a branded and unbranded, we'll be watching closely as to how these products compete in the commercial market vs the Medicare/Medicaid or Part D plans. So, which version of the product is going to get adopted and how quickly can it grow and into what levels? And then what learnings can manufacturers glean from the strategy that Viatris has taken, and can they take those learnings and apply them to other biosimilar markets, and I think Humira is 1 specifically that jumps right to the front of my mind. So, can this type of strategy be replicated in other markets? In staying on the topic of Humira, the approval and the launch of Semglee will most certainly act as kind of a dress rehearsal for bigger biosimilar market entrance expected in the Part D space in 2023. So, having an interchangeable product and having a Part D product, a pharmacy benefit product, is most certainly going to provide a lot of learnings and education around how the pharmacists' handle these products, how the pharmacy benefit managers handle these products, how they're positioned on the formularies, and how that interchangeable designation is treated at the pharmacy counter.

And then there's some excitement in the medical benefits of the Part B space with the forthcoming launch of the first biosimilar in the retina-ophthalmology space in Byooviz, which references Lucentis and we've talked about just a minute ago. Again, that launch is expected to happen mid-year in 2022. 2022 is also going to be the year where everyone is preparing for the watershed moment of the 7 plus biosimilars referencing Humira coming onto the market starting in 2023. And with the 7 plus Humira biosimilars entering the retail and specialty pharmacy space, a whole new customer group and market will be introduced to biosimilars. So, again, kind of going back to my point earlier around the education piece and how this continues to be a critical element to improve the adoption of biosimilars, the aperture expands exponentially as these retail pharmacy and specialty pharmacy products come onto the market.

And then just some considerations for the biosimilar market moving forward. We'll continue to watch how manufacturers of innovative products respond to biosimilars. A great example, Janssen towards the end of 2021 launched an unbranded version of Remicade [originator infliximab] similar to how Semglee was launched both branded and unbranded. Now, we've got an innovator product in the Part B space with a branded and unbranded [version]. We'll most certainly make note of whether or not this strategy is successful and then whether or not other innovator companies adopt a similar strategy. We're also expecting to see a new set of manufacturers launch biosimilar products into existing markets, as well as new biosimilar markets like Biogen with their Lucentis biosimilar. Finally, existing biosimilar markets will become more competitive with new entrants. All of this is really great in my opinion because these manufacturers continue to see an opportunity for biosimilars, and patients will benefit from increased competition that helps improve access and affordability.

CfB: Terrific, Sean, thanks. Finally, the Build Back Better Act has been through a lot of drafts, and we don't know whether it's going to see the light of day. What are your thoughts on how this might affect biosimilars in the final version, if there is one?

McGowan: Yeah, that's a great question and I know a lot of focus on the Build Back Better Act was paid in the November timeframe before the legislators shut it down for the end of the year. We're going to be following this very closely to see what policies actually make it into the bill, in whatever way shape or form that happens. I think we all want to see policies that continue to support a market that allows for biosimilar competition, encourages manufacturers to invest in the space, and helps to bring down drug prices and the overall cost of care. Despite all the challenges and hurdles the biosimilar market has had to overcome across the last several years, biosimilars have most certainly delivered on their promise to expand access, drive down costs, and deliver on savings.

CfB: Thanks very much, Sean. It's great talking with you again about biosimilars at The Center for Biosimilars.

Sean McGowan, senior director of Biosimilars for AmerisourceBergen, forecasts potential biosimilar approvals and launches in 2022 as well as offers insights into how emerging biosimilars will impact the market and pricing in the coming years during an interview.

AmerisourceBergen Rep Previews the Year Ahead for Biosimilars: What’s Coming Down the Pipeline in 2022?

In an interview with The Center for Biosimilars®, Cate Lockhart, PharmD, PhD, MS, executive director of the Biologics and Biosimilars Collective Intelligence Consortium, discusses some of the current barriers to biosimilar adoption in the United States and how the industry is working on overcoming them.

Lockhart explains that the status of biosimilar adoption has changed. There was uncertainty and lack of knowledge about the science when biosimilars were first emerging. Now, the uncertainty has been shifted to concerns regarding reimbursement and management, especially as more biosimilars are approved.

As market competition increases, Lockhart says, reimbursement capabilities and formulary designs become more important, because product stocking in a health system or hospital pharmacy is complicated. Providers may be forced to stock all biosimilars approved for a particular reference product and reimbursement may not apply equally for them.

She mentions that some practitioners have concerns over how benefit design and formulary practices will impact their daily workflow. Lockhart says incentives for payers to use certain products may support the use of biosimilars, especially now that there are multiple alternatives to some reference drugs.

Previously, most biosimilars were under the medical benefit; however, some pharmacy benefit biosimilars have started to emerge, and Lockhart is interested in seeing how these biosimilars will change the landscape. Lockhart expects pharmacy benefit biosimilars to play a more prominent role in the decisions that formulary managers make.

Emerging insulin biosimilars will be some of the first products to go through the pharmacy benefit, and Semglee (insulin glargine) was recently approved as a biosimilar with an interchangeability label. Lockhart explains that interchangeability designations for insulin products add complexity. Although she says it’s too soon to tell whether interchangeability will have a significant impact on adoption of insulin biosimilars, she believes more biosimilar manufacturers will seek interchangeability designations.

Finally, Lockhart dives into the subject of how biosimilars can be leveraged in use management programs, saying health systems should refine their coding and administrative systems to help ensure that programs run as smoothly as possible and that workflow is not disrupted.

Reimbursement concerns and the uncertainty of how interchangeability will impact biosimilar adoption are hot-button issues in the biosimilar space, Cate Lockhart, PharmD, PhD, MS, explains in this interview.

Cate Lockhart Explores the Evolution of Biosimilar Barriers 

In this abbreviated interview, Senior Editor Tony Hagen talks with Tahir Amin, Dip LP, a former intellectual property attorney who is now co-executive director of I-MAK (The Initiative for Medicines Access and Knowledge), which lobbies to overcome unfair trade practices and make medicines more widely available to patients. He recently testified on AbbVie’s drug patenting and pricing practices before the House Committee on Oversight and Reform.

Amin talked about some of the concerning practices he witnessed during his early career in patenting. He said that patent filers will carefully word patents to allow for multiple ongoing filings. This enables them to build large portfolios of patents that represent legal tangles for biosimilar competitors.

Regarding patents for the reference product adalimumab (Humira), Amin said so many have been filed by AbbVie that it’s too costly and difficult for biosimilar developers to contest them all. This is a failing of the US patent system, he says, because these webs of patents cannot be undone.

He discussed Alvotech’s ongoing attempt to fight AbbVie patents on adalimumab and said he is hopeful that Alvotech will be successful, but he noted that Boehringer Ingelheim previously went to court with AbbVie over adalimumab and eventually settled. This, he said, demonstrates that the patent system is being “weaponized” by originator companies.

Amin described AbbVie as having a “drip feed strategy” in which it files for patents broadly and over time. Originator companies will carefully patent every aspect of biosimilar development they can think of, even if they are no longer using the process that they’re patenting, and this, too, serves as an obstacle to biosimilar competitors.

Additionally, Amin commended Representative Katie Porter (D-California) on her questioning of AbbVie’s CEO, Richard Gonzalez when he testified before the House Committee on Oversight and Reform. According to Porter, AbbVie is not spending as much as it claims on innovation. The company has previously defended the high price of Humira by saying that much of the revenues are reinvested in development of new products to improve the health and lives of Americans.

Originator companies may lose the idealism that leads to new and better products and, instead, simply focus on maximizing their current revenue stream from existing products, Amin said.

Amin talked about the history of the patent system from the 1950s through the 1980s, saying how innovation boomed in the 1950s and then in the 1970s an economic downturn led to a shift in priorities. He said that, today, 11 million patents have been filed and roughly 50% are likely “junk.” That large number of patents is being used as a measure of innovation, which Amin doesn’t think is right.

When asked about his hopes for the Patent and Trademark Office (PTO), Amin said the incoming director should take into account the public interest and effects of drug pricing because the PTO, he said, has never acknowledged the role that patents play in rising drug prices.

Finally, Amin discussed how the COVID-19 pandemic has underscored the patent system problems, because protection of intellectual property and corporate profits has impeded getting the vaccine out to everybody who needs it. However, the public health crisis is causing more people to engage with these issues, and Amin said that this could lead to policy changes that improve the patent system.

 to watch the full Deep Dive interview, only on Medical World News®.

Tahir Amin, Dip LP, co-executive director of I-MAK, discusses some hot-button issues regarding the US patent system, including AbbVie’s alleged abuse of it, and his hopes for improvement.

Activist Lawyer Discusses AbbVie and Patent System Shortcomings

The Center for Biosimilars® recently spoke with Cate Lockhart, PharmD, PhD, executive director of the Biologics and Biosimilar Collective Intelligence Consortium (BBCIC), about biosimilar utilization, the possibility for the first interchangeable biosimilar, and the need for more real world evidence.

Lockhart discussed the granulocyte colony-stimulating factor (G-CSFs) drug market, which includes filgrastim and pegfilgrastim biosimilars. Although infliximab biosimilar uptake has been slow, G-CSF biosimilars are considered a success story, in that utilization trends for these products are trending upward.

She predicted significant evolution of the biologics market as more anti–tumor necrosis factor products and biosimilars are launched. Further, she noted that in the anti-inflammatory space, there are a number of nonbiosimilars and new originator products emerging. This trend will affect the utilization of biosimilars, she said. 

Lockhart also described the prospect for the first interchangeable biosimilar insulin (Semglee) as exciting, because it holds the potential for lower costs of insulin and some other interesting market dynamics.

The quality and availability of real world evidence has improved in recent years, although in some cases the data being used for assessment of clinical trends were not gathered for that purpose and so are not ideal, she said. The BBCIC and other organizations have worked to enrich the quality of these data so that the utility is more relevant to needs.

In part 2 of this interview, Cate Lockhart, PharmD, PhD, executive director of the Biologics and Biosimilar Collective Intelligence Consortium, discusses the potential for interchangeable insulin biosimilars and the challenges of obtaining reliable and optimized real world data.

Cate Lockhart: Putting the US Biosimilar Industry in Perspective

Hi, I’m Christina Mattina 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 biosimilars articles for the week of March 2, 2020.

Number 5: The outcome of 3 major biosimilar antitrust actions, as well as a related Federal Trade Commission investigation, could significantly change how biologics are priced, writes attorney Ron Lanton III in a 

 that assays used to evaluate circulating drug levels and antibody resistance for the Remicade version of infliximab are also appropriate for 2 infliximab biosimilars, SB2 and CT-P13.

 from the FDA related to an inspection at its insulin manufacturing plant in Malaysia, where the company will produce its insulin glargine product, referencing Sanofi’s Lantus.

Number 2: The US Court of Appeals for the Third Circuit allowed Walgreens and Kroger to 

 accusing Johnson & Johnson of unlawfully restricting access to biosimilar infliximab while pressuring healthcare providers and payers to use its higher-priced originator product, Remicade.

 for a patient with lichen planopilaris revealed significant hair regrowth when originator adalimumab was added to the patient’s hydroxychloroquine regimen. 

To read all of these articles and more, visit 

The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.

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