So patients have access to our helpline. They are able to either email us or call us if they do have a problem once switched. We’ve also, with our local support group, they have helplines that they can call. There’s lots of mechanisms to feed back any queries and to support patients who’ve switched.

Videos

Kalveer Flora, MPharm, London North West University Healthcare National Health Service Trust, discusses patient support options for those who switch to biosimilar adalimumab in the United Kingdom.

Kalveer Flora, MPharm: Patient Support During Switching

Well again that's yet to be seen. Of course we do have a biosimilar rituximab as you allude to. It’s now approved in the United States, and it’s actually been in Europe for a longer period of time, so we have some experience there, and in fact as last year's [American Society of Clinical Oncology, ASCO] meeting last June, a European group presented data on the early utilization of rituximab in patients with lymphoma in Europe. 

What was interesting there, and I think we may see the same thing happen here in the United States, is the utilization of the biosimilar rituximab was more favorable in patients with less curable forms of lymphoma. In other words, the oncologist was willing to use these new agents in a situation where the goal wasn't necessarily long-term survival or cure. They reserved the originator, Rituxan, for use in patients with, for instance, diffuse large B-cell lymphoma where the goal of treatment is usually cure. 

There’s some discrimination in the use of that, which is perhaps understandable because this is not just supportive care. This is the mainstay of treatment for these patients, and if you're treating for curative intent, do you really want to take any chances if you're not quite sure, or if you haven't used the drug before?  

So you’re more likely to use it in solid tumors in patients with metastatic disease perhaps or lymphoma with the low-grade lymphomas where your goal is extending life but not so much the likelihood of curability. 

That’s data from Europe, but my guess is we're going to see a similar kind of gradual intake and then over time broad utilization across the subtypes of lymphoma.

Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, discusses how biosimilar rituximab may be used in cancer care.

Gary Lyman, MD, MPH: Using Biosimilar Rituximab

The Supreme Court’s January 2019 decision in 

 is an important decision for biologics manufacturers and biosimilar companies. In that case, which was argued by our partner [William Jay, JD], the Supreme Court held that an inventor's sale of an invention to a third party could trigger the statutory on-sale bar even where the third party was obligated to keep the invention confidential.

This case has important implications for biosimilar manufacturers in that it is a warning that they need to be very careful about the types of contracts they enter into prior to applying for a patent. And it is an opportunity for biosimilar manufacturers in that it opens the door for potential on-sale defense invalidity argument, and biosimilar manufacturers should be careful to investigate and take appropriate discovery to determine whether such a defense is viable in any given case.

Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses the Supreme Court’s January 2019 decision in Helsinn v Teva.

Elaine Blais, JD: Helsinn v Teva and Its Implications for Biosimilar Developers 

That's very interesting question, because the prescribers are still not aware of the rigorous pathway—there’s something called the totality of the evidence that’s undergone in terms of evaluating the molecule. Many prescribers even now think that biosimilars and generics are the same. There’s a significant difference and a significant cost difference in developing a biosimilar, so there are a lot of misconceptions prevailing among my colleagues as well as many prescribers. As a chairman of the biosimilars committee at the [Community Oncology Alliance, COA], we’re trying to help address the knowledge gap and the needs assessment in the biosimilars market.

Kashyap Patel, MD, discusses the prevailing misconceptions about biosimilars among oncologists. 

Kashyap Patel, MD: Misconceptions About Biosimilars

I don’t know if you know that in the [United Kingdom, UK], biosimilar rituximab has taken the entire market. There’s no biosimilar subcutaneous, but the biosimilar intravenous basically has had a massive impact with respect to cost. The biosimilar that’s used in the UK was over 40% cheaper than the MabThera. From a healthcare system that buys a lot of drug, that’s a big, big impact. So from an intravenous point of view, we’re using the biosimilar. I don’t have a choice; that’s what we’re doing. But of course there's only 1 subcutaneous.

Certainly in the maintenance setting, the hidden costs of somebody being in a chair all afternoon versus the subcutaneous are massive. Even within the [National Health Service, NHS], that’s recognized. So subcutaneous within a maintenance setting is allowed. I think in maintenance, you need to give the subcutaneous. You could argue whether intravenous when you’re giving somebody intravenous chemotherapy is cost effective or not, and maybe it is because the patient is in the chair anyway. So that’s perhaps where you could argue for a biosimilar intravenous, but certainly maintenance, I don’t think there’s any role for an intravenous formulation over a subcutaneous one.

Simon Rule, MD, Plymouth University Medical School, discusses the role of biosimilar rituximab in the era of subcutaneous reference rituximab in oncology. 

Simon Rule, MD: Subcutaneous Rituximab Versus an Intravenous Biosimilar

At the policy level, among professional organizations like [the National Comprehensive Cancer Network, NCCN], again, I think there’s this hesitancy. This need to be educated. There, I think the biggest issue is they want to see the data. They want to see the evidence, and since these drugs are being approved by the FDA, sometimes that evidence is put in the public domain; it’s put on the web. If there's an Oncology Drug Advisory Committee meeting, all that's in transparent and available.

But the more recent biosimilars have been approved without that public disclosure. There, it's really critical that industry, that companies publish their data, their preclinical data and their clinical data, in the peer-reviewed literature.

We had one example recently, and that complicated our NCCN guideline update for the hemopoietic growth factors, where we neither had the public display of the evidence that the FDA reviewed nor any peer-reviewed publications. So as a guideline panel, we could not really recommend the use of that agent.

Eventually, the company forwarded that information to us directly, but my point is, FDA approval is just the first step, and equally important is that the evidence that the FDA reviewed for approval these agents has to be made available to the medical community, to the professional community, and to professional organizations like NCCN if they're going to be expected to endorse and recommend the use of these agents.

Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, discusses policy challenges with biosimilars. 

Gary Lyman, MD, MPH: Biosimilars and Policy

I’m quite optimistic on that. Why I’m optimistic is because the [World Health Organization, WHO] at the moment works on the pilot prequalification process for trastuzumab and for rituximab.

What does it mean in practice? If, for example, a trastuzumab is approved, is prequalified by the WHO, that could be, for example, a US-approved product or a biosimilar, or a European biosimilar, they have used a comparator in biosimilar development, but the product itself will be used around the world where it has been part of [United Nations, UN] tender or governments want to have access to that prequalified product. Automatically, that comparator, which has been used in the biosimilar development, becomes a global comparator product.

I think we will take that up with the WHO once that process is completed so that we get a list of comparator products which can be used for biosimilar development. They have defined that already in their procedure itself, so I think that’s very promising, because we are really here in the practice, and we can build on that.

Furthermore, we have identified that a number of countries around the world accept, already, a foreign comparator product in biosimilar development which is representative of their reference product. As IGBA, we are for the moment working on a positive list of those countries, and we will make that public once that task is completed. So I’m quite positive on those developments.

Suzette Kox, MPharm, Secretary General of the International Generic and Biosimilar Medicines Association (IGBA), discusses progress made toward the use of global reference products in biosimilar development.

Suzette Kox, MPharm: Global Reference Products in Biosimilar Development

Biologics and biosimilars are evolving so quickly it's hard for anybody to keep up. From an educational standpoint, every school of pharmacy is trying to change its curriculum as quickly as possible, but if you received a lecture last year and something changes this year, we don’t always get that new information into that third-year or fourth-year class. So I think, as the new pipeline comes through, they’re getting trained in the latest and greatest, but we need continuing education of people who either have already graduated or are further along in their training to make sure that it's not just the next generation, but it's the current generation of pharmacists that are equipped to handle biologics and biosimilars.

C. Daniel Mullins, PhD, chair of pharmaceutical health services research at the School of Pharmacy, University of Maryland, describes the state of pharmacy school curricula related to biosimilars.

C. Daniel Mullins, PhD: Biosimilar Education and Current Curricula

I think the Danish patients are being impacted in several ways. Firstly, more patients have now access to biological treatment than what they did before; as we all know, biologic medicines have been very, very expensive. They have also been very efficient, but they have been very expensive in Denmark. Last year, of 25 products being used in Danish hospitals, 24 of them were biologics. Of course they have been expensive, but now when you add biosimilars into the market, more patients are being treated, and they're being treated earlier.

At the same time, this would also free up money in other places of the system. We all know we are having a lot of new cancer products coming in. They are, I assume, efficient, but for certain, very expensive.

The fact that you can save a lot of money by using biosimilars will, as I say, free up money that means that other patients, cancer patients, for instance, can benefit because you can start to use new treatment at an earlier point in time without jeopardizing the total health care budget.

Peter Jørgensen, director of the Industrial Association for Generic and Biosimilar Medicines, Denmark, explains how Danish patients are benefitting from biosimilars. 

Peter Jørgensen: The Impact of Biosimilars on Danish Patients

I think it is very important to keep reporting these things because, even for people doing oncology for years and decades, it’s still very difficult to really differentiate between a generic medication and a biosimilar. A generic is simply like cooking the same recipe, and developing a biosimilar is completely different. It’s really developing a new medication; you just do it the other way around. It is reverse-engineering because you have to find out what the original company was doing.

The effect regarding healthcare economics is that, of course, you can sell that cheaper because developing a new antibody is an investment of more than $1 billion usually, whereas developing a biosimilar for a known antibody costs about $200 million dollars.

So actually the prices in the end are cheaper, which is of course important in countries like the United States or in Germany, where I work, because we save money we can use for other things in the healthcare system. But it's even more important in places where giving a patient an antibody is not a question because there's no money for that. Like in the developing countries. For those, biosimilars may be a huge chance to gain access to antibodies at all.

Hans-Christian Kolberg, MD, head of the department of obstetrics and gynecology, breast cancer center, and gynecologic cancer center at Marienhospital Bottrop, Germany, reflects on the importance of reporting new cardiac data from the LILAC trial of ABP 980, a trastuzumab biosimilar.

Interviews