Biosimilars are a real game-changer. In the same way that we've seen a reduction in price as we see traditional medicines going to branded, we're seeing the same thing with biosimilars.

If you would have asked me what am I potentially worried about, if you look back to the literature, when generics first came out to the market in the more expedited role, there was a generic drug scandal, and if anything were to happen where there were a biosimilar that was used that we found out really wasn't as good as the originator biologic, that could set biologics back.

But short of that, I really do believe that this is going to be good for the American public.

Videos

Daniel Mullins, PhD, chair of pharmaceutical health services research at the School of Pharmacy, University of Maryland, discusses how biosimilars are impacting the cost of care. 
 

Daniel Mullins, PhD: How Biosimilars Are Impacting Costs

With the adalimumab, again, we used our experiences from our previous switches, so locally, in North West London, we work very closely with our patient support groups. We have a patient support group specifically for patients with arthritis, so we involved all of our patients when we wrote letters or patient information leaflets. We asked patients to come along to presentations that we were having. At all stages through switching, we invited patients and we worked together with patients.

Patients generally understand the need to switch to the biosimilar in order for the [National Health Service, NHS] to realize their savings, so patients have knowledge that, yes, we are switching so the NHS has money.

So I think our experience is, patients understand and they’re more likely to switch because they know that it's for the greater good of the NHS. That's something that we’ve certainly seen in North West London where we’ve done the switch to adalimumab biosimilars.

Kalveer Flora, MPharm, London North West University Healthcare National Health Service Trust, discusses how patients have reacted to being switched to biosimilar adalimumab and how they have been supported in the switching process. 

Kalveer Flora, MPharm: Patient Response to Switching to Biosimilar Adalimumab 

If I look at the market unfolding, let's say, I think one of the very important notions that needs to be reconciled is the short-term policy regarding budget management and the longer-term goal of healthcare equity and a greater quality of care because you can't forget that end goal and compromise it; you need to make sure you have thoughtful policies in place today so that you're not compromising meeting the big end goal.

I think this is essential and it has to do with a general education that competition in the pharmaceutical market is a dynamic and cyclic system, and for that, the time element is really important. It has to be seen in a bigger time frame than just the cycle of a call for tender or a purchasing bid, or this type of element.

For us, the challenge this year will be to make sure everybody in the healthcare community, from the makers to the end users, do have that time element to it. Yes there is “what's in it for me?” at every bit, but I think the time element will condition how deliverables are are actually happening or not, so this is really important.

Julie Maréchal-Jamil, director of biosimilars policy and science at Medicines for Europe, describes the challenges ahead for the European biosimilars market.

Julie Maréchal-Jamil: Challenges for Biosimilars in Europe

I think it's not just pharmacists. It's the overall healthcare team and provider team. Right now I think we're still in a new and emerging area. Hopefully, shortly we’ll also see biosimilar insulin on the market, too, and that’ll be a great discussion; that’s a big topic right now in the biosimilar area.

For pharmacists, I think there needs to be a lot more discussion on how drugs are getting approved, what is the regulatory process: phase 1, phase 3. We also need to go over and delineate a lot more discussion on the global implementation of biosimilars to help provide more of a foundation for discussions here in the [United States, US].

Other areas which are requiring a lot more education: [continuing education, CE], review articles as well to get the information out there in the next few years. We need more discussion on [pharmacy and therapeutics, P and T] implementation, how that works. Reimbursement is going to be critical in this area, and there is a pure lack of understanding of reimbursement. 

In fact, if there's one thing that can be done, it’s to create a level playing field for the understanding of reimbursement, both from a private payer and also government payer type of situation to make sure everyone is on the same page. I feel the more we talk about this, the more the education goes on on this, it will only help better provide resources for patients, but also institutions. So pharmacists really need to be aware of that as well.

Ali McBride, PharmD, MS, BCPS, clinical coordinator of hematology/oncology at the University of Arizona Cancer Center, discusses pharmacists' educational needs on biosimilars.

Ali McBride, PharmD, MS, BCPS: Pharmacists' Educational Needs on Biosimilars

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.

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.

Interviews