Biosimilars are a totally new class of drug in the United States, and unlike generics, there's a complex science involved in developing biosimilars.

But there’s a tremendous knowledge gap between the providers. Multiple studies have shown that between 1 and 4 to 1 and 2 doctors are not familiar with the FDA pathway, which is 351(k) for the biosimilar.

So [the Community Oncology Alliance, COA] plays a central role in evaluating this knowledge gap and bridging that gap by bringing the evidence-based scientific education piece to all the stakeholders, which includes in patients, physicians, as well as providers.

Videos

Kashyap Patel, MD, discusses the goals of the Community Oncology Alliance (COA) in forming its biosimilars committee.

Kashyap Patel, MD: COA's Goals for Its Biosimilars Committee

I think the challenges, I look at them as 2 levels: one is for the provider and to some extent the patient, and that is skepticism. These are approved by a different process, different mechanism. We’re used to seeing these large phase 3 trials demonstrating efficacy and safety, and we're not seeing that with these, so there’s a skepticism, and many not wanting to be the first physician in their group to use a new agent when they've gotten very comfortable with the original biologics approved 20 years ago.

So I think there we need more education. [The American Society of Clinical Oncology, ASCO] has had a major effort that I had an opportunity to work with. We published some educational guidance in the 

 2 years ago. We’re putting on educational programs at the annual meeting, the same at the American Society of Hematology, and now here at [National Comprehensive Cancer Network, NCCN], so I think education about what a biosimilar is, what's the process, how it’s different, and why we should even rely on it, so that's very important

There's also some skepticism about how much of an impact on cost these agents will have and whether it really will bring down the incredibly high cost and rising cost of cancer care delivery in the United States.

It's not the whole solution, but I personally think it's a piece of the solution. We need other things at the policy level to rein in healthcare costs, but I think by biosimilar competition and reduced pricing can really help.

Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, describes challenges with incorporating biosimilars into cancer care.

Gary Lyman, MD, MPH: Challenges With Incorporating Biosimilars Into Cancer Care

That’s a very interesting question that you asked, because the rituximab biosimilar is very warranted and is here. The originator has come out with a new subcutaneous molecule, which probably is priced less than their own reference product in terms of [intravenous, IV]. So we are evaluating the patient convenience option first, because for the intravenous rituximab, the patient has to be in the office for about 6 to 8 hours, and the originator has another molecule that is subcutaneous, which actually could be given in 15 minutes.

The other part is, because the subcutaneous molecule is a fixed dose, it probably [average sales price, ASP] calculation-wise, may become less expensive to the healthcare system as a whole. So right now we are in a holding pattern to evaluate the time in motion, the characteristics of both molecules, and depending on what is best for the patient, depending on what improves the healthcare-related quality of life, and depending on which molecule is helping address Part B drug prices will help us make a decision. Unless and until we have the biosimilar molecule out, and it’s priced at a very competitive place, we will have to look into all of these aspects before we decide to switch over to the biosimilars.

Kashyap Patel, MD, discusses considerations for using biosimilar versus subcutaneous rituximab.

Kashyap Patel, MD: Preparing for Biosimilar Versus Subcutaneous Rituximab

I think biosimilar education is still needed to understand the regulatory difference between the originator product, which has to show in phase 3 trials that it's better or noninferior to another agent, and that it has efficacy and safety. The FDA approves initial drugs based on efficacy and safety. Biosimilars are approved with less clinical evidence because they're really mirroring the originator products, so it's highly technical in terms of the analytic variables that have to be satisfied for a biosimilar compared to an originator. As oncologists understand that process better, they'll become more comfortable with it.

Lee Schwartzberg, MD, FACP, The West Clinic, explains the kinds of education that oncology providers still need to feel comfortable with biosimilars. 

Lee Schwartzberg, MD, FACP: Biosimilar Education for Oncologists

With my particular trust, we’ve been using biosimilars, or best-value biologics, for nearly 3 years now. Within each transition, we’ve gained a lot of insight and knowledge from the last one. We’ve had a very positive experience from all of our uptakes.

I’m very lucky that the team that we have, especially the rheumatology department, is very forward-thinking in terms of encouraging uptake of biosimilars and using them for our patients. So we’ve had very positive experiences.

With the first switch that we did, that was an infliximab biosimilar, that went well. That was an [intravenous, IV] switch, so patients were informed when they came in to have their infusion.

The second switch that we did was for etanercept. This is a subcutaneous product; with a subcutaneous switch, there are other considerations you have to think of. Because it’s a drug delivered through home care services in the [United Kingdom, UK], you have to manage the home care services, so that was slightly trickier, but we had very positive experiences with transitioning our patients. We transitioned maybe 300 patients, so that was a big switch for us.

After etanercept came rituximab, which was again easier because it’s an IV switch, so there were less monitoring and negotiations with home care services. Patients were also told when they came in to have their infusions.

And last, the adalimumab, which has also been a big switch for us, and which has gone very well. That’s because we’ve had a vast experience with previous switches that we can always then use to plan how we would do this switch.  All in all, a very good experience with switching.

Kalveer Flora, MPharm, London North West University Healthcare National Health Service Trust, discusses her trust's extensive experience with switching patients to biosimilars. 

Kalveer Flora, MPharm: Experience With Switching to Biosimilars

I think it's fair to say that it has been very positive. You know, it was introduced not that long ago, less than half a year ago, and the uptake in less than a month was 90%. Not 19%, but 90%.

In effect, Humira, which was by far the biggest pharmaceutical on the Danish market, has been wiped out completely from Danish hospital shelves. You just can’t have Humira anywhere in Denmark anymore. Even though they offered a rebate on 78%, that was not enough to keep them on the market for 2019.

In accordance, the Danish tender system has gone to 2 products where they have offered a rebate of 86%. So on the one hand, you have uptake of 90%, and you have a rebate on 86%. Imagine what that would do not just for the public health, the health economy of the Danish healthcare sector, but also for the patients, because at the same time, since the product has become cheaper, more patients have gotten access to the product.

Peter Jørgensen, director of the Industrial Association for Generic and Biosimilar Medicines, Denmark, explains the Danish experience with biosimilar adalimumab.

Peter Jørgensen: The Danish Experience With Biosimilar Adalimumab

The issue is whether these biosimilars will achieve the goal of reducing prices in reducing healthcare costs. And in actual fact, data in Europe (again, they’re about 10 years ahead of us) suggest perhaps a 20% to 30% reduction in pricing when competitive by biosimilars are available in the marketplace.

We're too early to know whether we'll see that type of impact in the United States. If we do, even a 20% to 30% reduction in cost in a multibillion-dollar industry is a large amount of money, so it would be useful, but we don't know yet whether that will actually happen.

 this past year, looking at the early utilization of the hematopoietic growth factor biosimilars suggest maybe about a 10% reduction in price so far, but now we have 5 competitive hematopoietic growth factor biosimilars, we now have 4 trastuzumab or Herceptin biosimilars for breast cancer patients, so as we get multiple competitors in a class of agents, there should be more competition and hopefully a greater impact on price.

Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, discusses how biosimilars could impact the cost of care.

Gary Lyman, MD, MPH: How Biosimilars Will Impact Price

This year for us is very special because we have European elections. It's a time when the political agenda gets quite reset for another 5 years, so it's very important and for us, it's important that the parliament that will be elected in May and then the European Commission that will be formed then in the fall all have a strategic agenda for health. That's very important for us, but more importantly that they have a reserved place for biosimilars to play an important role in that agenda.

Two points: I think, in Europe, there's a big focus on reducing inequalities in access, and biosimilars are very obvious and readily available to contribute to meeting that objective, so I think we're calling on the institution this year [in a very] big [way] to to have that strategic inclusion of biosimilars in meeting their health objectives.

The other bit is more on the industrial side of things, where biosimilars were born here in Europe because of how the system was set up early on, their legal framework and everything, but we haven't fared very well in manufacturing capability and know-how; that really needs to be nurtured because the the needs are growing in Europe and elsewhere, and I think it's important that we nurture that for the long-term.

So 2 agendas: one more on the equity, creating greater equity, and the other more on the industrial policy side. So this is our big agenda for 2019.

Julie Maréchal-Jamil, director of biosimilars policy and science at Medicines for Europe, describes opportunities for biosimilars in the year ahead.
 

Julie Maréchal-Jamil: Opportunities for Biosimilars in 2019

Nurses have been explaining to the patient what biosimilars are—some of the basic education that they are like generics, they have undergone enormous amounts of safety and efficacy as well as pharmacokinetic studies. So they really alleviate any concerns and anxieties that the patients have when we switch patients over, or when we start any new patients on the biosimilars.

Kashyap Patel, MD, explains the role that nurses play in educating patients about biosimilars.

Kashyap Patel, MD: Nurses' Roles in Biosimilar Education

Recently FDA has changed its guidances on how companies can make communications about their drugs and devices. There [are] actually 2 separate categories: one is economic information, like, for example, is a drug cost effective or how does it say, reduce the length of hospitalization, what kind of money does that save. The other one goes into what kind of communications, what things that companies say that are consistent with the labeling of a product.

Both of these guidances essentially have slightly liberalized what companies can say by giving companies more guidance on what is permissible and what is impermissible. The healthcare economic one, in particular, companies really wanted to see because there have been 2 laws in the last 15 years where Congress asked FDA to do more in that area and give more guidance.

So that one is great now because now we know particularly prior to approval for example, that you can go and talk with payers and show more data about what has this product done in clinical trials.

James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, discusses the implications of recent FDA guidance on medical product communications.