Gillian Woollett, MA, DPhil, senior vice president, Avalere Health, explains potential consequences if the US were to do away with biosimilars.

If the US were to do away with biosimilars in favor of price regulation for innovative drugs, what might happen to biosimilars in the rest of the global market?

Well, I think we have to start with how totally un-American it would be and I say this as a putative ex-Brit and definitely American. It would be to just do away with a potentially competitive framework. Now, there's no question biosimilars are struggling in the US. Insofar as they're struggling, maybe there's some changes that are needed to the pathway to enable them to actually get to market, get through what's been known as the patent thicket, and then have commercial models. But to unilaterally just dispose of a pathway that's allowed 23 products to be approved, strikes me as awfully premature and probably not helpful for anyone. Now, in terms of the rest of world, I do think there's a bigger sub-question to what you asked. That is, if the US doesn't succeed and doesn't provide the return on investment (ROI) for the substantial dossiers that are being compiled, about $100 million to $500 million it's costing—which is 100 times that of the average generic&mdash;if the US is not providing the ROI for a biosimilar, what does that mean for the global market? I think there's a very real risk that the rest of the world cannot provide the ROI that we in the US do, given we're 60% by dollar value of the originator biologics market.

Videos

Gillian Woollett, MA, DPhil, senior vice president, Avalere Health, explains potential consequences if the United States were to do away with biosimilars.

Dr Gillian Woollett: Loss of Biosimilars Will Impact the US Market

Adding rituximab to venetoclax allows for a 2-year fixed duration treatment schedule for patients with chronic lymphocytic leukemia, said Lindsey Roeker, MD, clinical fellow at Memorial Sloan Kettering Cancer Center.

What are some factors that predict outcomes for patients with CLL who use venetoclax alone or venetoclax with rituximab?

So we know that there are genetic features that make people higher risk when treated with venetoclax, and those are well-defined genetic features. We've used real-world evidence to look at whether how much that anti-CD20 antibody is adding to venetoclax. And really, I think the role that plays is allowing for a time-limited therapy per the MURANO data. So adding rituximab to venetoclax allows for a 2-year fixed duration treatment schedule, whereas venetoclax as a monotherapy has traditionally been used as an ongoing therapy. I think the role of the CD20 is really, we have data to say that that can be a time-limited therapy.

Can biosimilar rituximab help make combination therapy for patients with CLL more cost effective?

Absolutely. I think as we have more options that are more affordable, these will be options that are available for more patients all around the world. And I think that's a really exciting opportunity. I think within academic communities, I think that there will be uptake. It's unclear to me what the practitioners in the community are going to be doing. I have less of a finger on the pulse there.

Lindsey Roeker, MD, clinical fellow at Memorial Sloan Kettering Cancer Center, discusses adding rituximab to venetoclax to allow for a 2-year fixed-duration treatment schedule for patients with chronic lymphocytic leukemia (CLL).

Dr Lindsey Roeker: Adding Rituximab to Venetoclax in Patients With CLL

The Biologic Price Competition and Innovation Act actually has a portion of the act in March 23, 2020. The insulin products and similar protein products will become biologic products. So they move from the Food, Drug and Cosmetic Act over to the Public Health Service Act, and they'll go from [New Drug Application] NDAs to [Biologic License Application] BLAs. With that situation, what it's going to allow is biosimilar products to then compete against the 351(a) insulin products, and this competition that's going to occur will help improve affordability and access of insulin products for patients.

Brian Lehman, MBA, MHA, RPh, director, Medical Account Management and Strategic Alliances, Sandoz, discusses the March 2020 transition of insulin to the biologics pathway.

Brian Lehman, MBA, MHA, RPh: Impact of Biosimilar Insulin on Patient Affordability

In biologics the whole question, [as] for biosimilars, has been whether they can be defined analytically. We now have the methods to define them sufficiently well that the question becomes, what else do you need? So our confirmation of sufficient lightness is based on the analytics, establishing that indeed, the two products you're comparing—the reference and the biosimilar candidate&mdash;are sufficiently alike, and we chose the new terminology so as not to imply a difference. And once you've got the confirmation, sufficient lightness analytically, then what our paper shows&mdash;and that'll be referenced&mdash;what our paper shows is that the biosimilars worldwide in US, Europe, Australia and Canada, if the PK [pharmacokinetic] matches, that product was going to be approved as biosimilar. So that then becomes the confirmation of sufficient likeness. And what we're asserting in the paper is there's no need for additional clinical studies, because they won't tell you anything. And if a clinical study won't tell you anything, it lacks scientific validity. Therefore, it lacks ethical validity. And it shouldn't be being done, and certainly not routinely.

We also would like to note that our paper, which was published in August [2019] in 

, subsequently, the European regulators have published a paper, also in 

, and they're coming to the same conclusions just based on European data. So we think there's definitely a case to be made here to revisit what you're doing, and therefore a new paradigm is entirely appropriate

 and we just like confirmation of sufficient lightness.

1. Webster CJ, Wong AC, Woollett GR. An efficient development paradigm for biosimilar 

. 2019;(33)603. doi: 10.1007/s40259-019-00371-4.

2. Wolff-Holz E, Tiitso K, Vleminckx C, Weise M. Evolution of the EU biosimilar framework: Past and future. 

. 2019;(33)621. doi: 10.1007/s40259-019-00377-y.

3. Vulto A. Delivering on the promise of biosimilars. 

. 2019;(33)599. doi: 10.1007/s40259-019-00388-9.

Articles

Gillian Woollett, MA, DPhil, senior vice president, Avalere Health, discusses how  “confirmation of sufficient likeness" should replace “totality of evidence” in biosimilar development.

Gillian Woollett, MA, DPhil: Creating a Paradigm Shift in Biosimilar Development

We have a couple of really exciting projects that we're just gearing up to get going now.

One is another one of these infrastructure projects where we're looking at the data feasibility and the capabilities within our distributed research network administrator claims. It's often difficult to find, to identify, clinical outcomes. And cancer has a very specific set of outcomes that we're interested in. And so we're looking at how can we expand our existing data network, while still keeping the multistakeholder environment intact, to give us the capability to do the same kind of research that we're doing in nononcology products and translate that over into oncology.

So that's an infrastructure project that we're that we're working on now. And we are just launching our first full-scale comparative effectiveness study in the G-CSF [granulocyte colony-stimulating factor] products because we have enough utilization in in the US to allow us to do that. That'll take 18 months or so before we're really finished with that by the time we launch, but that's going to be a really interesting project and, and I think that's going to help define some of our future projects.

Cate Lockhart, PharmD, PhD, discusses the research reports the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) plans on releasing in 2020.

Cate Lockhart, PharmD, PhD: Upcoming Research From the BBCIC

Absolutely, they already have. So what we’re seeing in the biosimilar front is actually a greater adoption than most folks thought initially. And for the non—supportive chemotherapy agents like Avastin, Herceptin, Rituxan, you know, we were thinking it might be a 10% adoption right away. It's looking more like it's 15 to 20%. So I think you can see that trend continue. Biosimilars are going to be here to stay in my opinion, and it's going to be a great opportunity for community oncology.

Tesh Khullar, senior vice president and advisor, Flatiron Health, discusses the impact biosimilars could make in community oncology.

Tesh Khullar: Biosimilars in Community Oncology

In early 2020, I think what I'm going to be very interested in seeing is how the market responds to having multiple biosimilars in certain their therapeutic areas. We're already seeing it with the pegfilgrastims now. There's more and more becoming available, and there was just one approved yesterday.* So to understand how health systems are going to really make the decision between multiple options for biosimilars is what I'm going to be really looking out for, and whether or not it's really going to come down just to the price, if there's going be any differentiator as part of it I think will be interesting to see.

Sonia T. Oskouei, PharmD, vice president of innovation and solution development at Premier Inc, discusses what she will be watching closely in the biosimilars space in early 2020.
 

Sonia T. Oskouei, PharmD: Biosimilars in 2020

We're seeing, and Amgen was the first one to do it, where they went right to the payer. They went to UnitedHealthcare and made sure that their not only branded Neulasta but their biosimilars are on preferred therapy for UnitedHealthcare, which then dictated down to practices needing to utilize it for United Healthcare patients.

So what you're going to see, in our opinion, are biosimilar manufacturers going to payers, getting them on formulary. It's actually going to be a big problem for community oncology. From a financial perspective, it's going to be an opportunity, but the logistical problems of having the brand of biosimilar different by payer is going to be an operational nightmare to manage.

Tesh Khullar, senior vice president and advisor, Flatiron Health, discusses challenges with reimbursement for biosimilars in community oncology practices.

Tesh Khullar: Reimbursement for Biosimilars

So, I do think bringing down the cost of therapy is important. It has to be affordable—these patients are usually on it for long periods of time. This is a chronic illness, so we are dealing with the healthcare value-based system as a whole. I do think that biosimilars, in my mind, when they were first being developed, was that they would have huge cost savings. So, in my mind, huge cost savings is not 10%, 20%, 25%, which is what we’re seeing. To me, huge cost savings is at least slashing it down by half. Half price&mdash;50%, right? So, I’m not seeing that.

So, I do think that it’s not as cost saving as I had hoped. So, it’s a little bit of a letdown when I’m only seeing a small percentage decrease in biosimilars.

Elaine Husni, MD, MPH, vice chair and director of the Arthritis and Musculoskeletal Center in the Orthopedic and Rheumatologic Institute at the Cleveland Clinic, discusses whether biosimilars are generating cost savings for patients with inflammatory diseases.

Elaine Husni, MD, MPH: Biosimilars and Cost Savings for Patients

Yes, absolutely. So that's something that we work really hard with our utilization management team on we want to make sure that they have all the information available, because they really are kind of clicking those clinical boxes that says whether something should or shouldn't be supported.

So when they're when they're putting in that prior authorization information that they have everything they need to make the most appropriate selections, so that then there's less of a holdup, or denials, or things that have to go to peer-to-peer. We want it to be as smooth of a process as possible.

Rhett Wilkerson, associate director of patient financial services, Florida Cancer Specialists, discusses how utilization management strategies impact patient access to biologics. 

Interviews