What are some of the cases you’re working on now? 

So one of the major cases we’re working on is Sofosbuvir, branded as Sovaldi. It’s a hepatitis C drug, and currently we filed 10 IPRs last year in the United States [Patent Trial and Appeal Board, PTAB]. Currently, we’re waiting to hear whether those will be instituted, and by instituted, I mean whether the PTAB will take those cases on and will go into trial. 

We have a number of cases going on in India involving hepatitis C drugs, and in China we already had some successful decisions. 

The importance of these cases is to show that a lot of people are still not getting these new, direct-acting anti-viral hepatitis C drugs, and we feel that our work is to try and create an opportunity for people lacking access to get them. 

Also, in the United States, a lot of people living with hepatitis C are not getting the treatment that they need, and I hope the cases we have brought will leverage some opportunities to try and get these drugs at more affordable prices, because only 1% of the number of Americans that need the drug are getting it at the moment. 

Videos

Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses his organization's ongoing work in challenging drug patents. 

Tahir Amin: Ongoing Work in Challenging Drug Patents

What are some new directions in treating inflammatory diseases that you’re particularly excited about? 

So, the first, I guess, and it’s not that new, is early diagnosis. It’s a way to classify the disease sooner than later, having a blood test to be able to do so in a number of people, though not all. Also, part of it is having people understand that the expectation is to get people into remission in the first year, and then, keep them there, as sort of new standards and new guidelines. Another part of it is the translational side of it. There’s a huge effort to now try and understand how the tissue in the rheumatoid joint is functioning in terms of cell-cell interactions, and sending things in and out of the blood to get a new understanding of how the tissue functions to perpetuate the disease and even start the disease. We don’t think it starts in the joint. We think it starts in the mucosa and something travels to the joint, but we don’t know why. And then a whole interaction of cells comes, and they have a party, basically, and they start to work with each other to build what is more like a benign tumor in the joint, and that, in and of itself, is very destructive.  

Vivian Bykerk, MD, associate attending rheumatologist at HSS, associate professor of medicine at Weill Cornell Medical College discusses new treatments in inflammatory disease.

Vivian Bykerk, MD: New Treatments in Inflammatory Disease

How does the biosimilar market compare to that of generics?

Certainly, with the regulatory pathway, to me, that’s where it diverges. Beyond that, I don’t see it as really being divergent. If you think about biosimilars— if they are approved as a biosimilar– that means they are significantly similar. It’s not identical, you know, because it’s a biologic, but it needs to be substantially similar and [have] no clinical difference. 

In a sense, in spite of the regulatory process, there’s no evidence of any clinically meaningful difference. In that sense, the divergence really is post-regulatory, in my opinion, where it’s a matter of education among prescribers, patients, [and] payers, but then in the United States that’s not really the hurdle for utilization. 

So, I don’t know that this necessarily diverges from the generics scenario other than it is certainly a scenario that we did not fully appreciate would come to pass in that, the reason for slow uptake in the United States is not wholly because of concerns about safety and effectiveness. It’s more tactical on the part of pharmaceutical companies— these are business decisions, this is a business– and that’s perfectly fine. But, the effect is creating a marketplace where even though we now have 11 approved [biosimilar] products in the US, only 3 are currently on the market. 

That’s a place where it diverges from generics in a way, although, we did see similar problems with generics [such as] slow uptake of generics back in the day because of the uncertainty. 

Cate Lockhart, PharmD, PhD, discusses the similarities and differences in the biosimilar and generic markets. 

Cate Lockhart, PharmD, PhD: Biosimilar vs Generic Markets

What role do you see biosimilars playing in increasing access to care?

Biosimliars have the potential to greatly increase access to care. Biologic agents in general have revolutionized the management of many, many rheumatic diseases, starting with infliximab in 1999, which completely changed the natural history of rheumatoid arthritis from what it was prior to the availability of [tumor necrosis factor] TNF inhibitors. Now, of course, we have a whole array of biologics that we can use. So, they’re fantastic drugs as a group, but they’re fantastically expensive— $50,000 a year and upward. And it’s going to bankrupt the system to say nothing of patients who potentially don’t have insurance access to these medications. So, the availability of biosimilars, if they are as efficacious and safe, and if– the big if– the price is low enough, there’s real potential to improve access. The problem has been that the pricing has only been 15% lower than the original drugs, which is nowhere near as low as we originally hoped, and there’s a whole variety of factors that go into that, but it’s something that we need to work on, particularly in this country. In Europe, the price differential is far greater.

Anne Bass, MD, rheumatologist at the Hospital for Special Surgery and professor of clinical medicine at Weill Cornell Medicine, discusses the potential for biosimilars to increase access to care.

Anne Bass, MD: Increasing Access to Care

Will the BBCIC’s work help with patient acceptance of biosimilars?

I think patients overall are much more sophisticated than people often give them credit for, you know, it’s people like me, people like you. So, I think not all of the patients are going to grasp maybe the nuances of what may come out of the research I’m doing with the BBCIC. But also, some of that comes down to how we communicate it. We can certainly put together a story that is appropriate for or is going to be meaningful for a patient or a patient group, or a patient advocacy organization for example, and we are engaging with patient organizations to help inform our research questions which is really helpful, so we’re answering the right questions for them to the extent possible within our constraints.    

I think it’s both educating and providing evidence for physicians to make their decisions, as well as for patients, because the patient has a role in their healthcare obviously. Now more than ever patients are being a lot more in charge of their own healthcare. So, I don’t think we can necessarily split those or silo those. How we communicate our information and our science may be a little bit different depending on the audience, but I think its beneficial for everybody to understand their treatment and their treatment options. 

Cate Lockhart, PharmD, PhD, discusses whether her work with the BBCIC will help encourage patient acceptance of biosimilars. 

Cate Lockhart, PharmD, PhD: Patient Acceptance of Biosimilars

Are there some emerging directions in treating inflammatory disease that you’re particularly excited about?

I think the area that we most need to work on is trying to figure out which patients do the best on which therapies. Some patients do very well the first thing you use, but we’ve all had experience with patients who need to cycle through a variety of medications before we find the 1 or the combination medicines that works just right for them. It would be wonderful if we had a test from the beginning that could tell us that we need to target 1 pathway and 1 patient, and a different pathway and a different patient. We’re not there yet, but that’s certainly a direction that we’re moving in as we begin to understand these diseases on a deeper level pathogenetically.

Anne Bass, MD, rheumatologist at the Hospital for Special Surgery and professor of clinical medicine at Weill Cornell Medicine, talks about some emerging treatments in inflammatory disease.

Anne Bass, MD: Emerging Treatments in Inflammatory Disease

Immune checkpoint inhibition for cancer therapy can result in musculoskeletal adverse events, how are these adverse effects treated in the rheumatology clinic?

So, this is a really exciting area because these immunotherapies are prolonging the lives of people with metastatic cancer who had otherwise would’ve died. They work by stimulating the immune system and allowing it to target the cancer. Not surprisingly, when you stimulate the immune system, you can cause autoimmune diseases; and that’s what we’re seeing and they take many shapes and forms. Some of the earliest ones we knew about were immunity in the skin and colitis involving the gastrointestinal track, but as time has gone on we’ve come to realize that some of these patients— probably about 5%– develop an inflammatory arthritis and it can take, again, many forms.

I think one of the reasons there was a little delay in recognition is that it may be a little bit more common with some of the newer immunotherapies that target PD-1 and PD-L1 as compared to the older therapies with CTLA4 blockers, and it's seen particularly [common] when you use those 2 groups in combination. So, patients will come to a rheumatologist as they would if they had inflammatory arthritis that developed in some other context and these patients have all different kinds of presentations. Some of them have zero-positive rheumatoid arthritis that looks for all the world like rheumatoid arthritis, others have fewer joints affected, or they have tendons that are swollen. We’ve seen polymyalgia rheumatica, and their case is almost of every rheumatic disease you can think of with these checkpoint inhibitors. There are many fewer cases of things like lupus and drama monocytes though than there are of patients with rheumatoid arthritis, psoriatic arthritis, and the inflammatory rhinitis in general. 

Anne Bass, MD, rheumatologist at the Hospital for Special Surgery and professor of clinical medicine at Weill Cornell Medicine, discusses how rheumatologists treat musculoskeletal adverse events caused by immune checkpoint inhibitors.

Anne Bass, MD: Immune Checkpoint Inhibitors in Rheumatic Disease

When will we see price competition on biosimilars?

I think if you think of it in a purely economic, capitalistic sense then you should expect, like [with] generics, with 3 [biosimilars on the market] it’s enough competition to bring that down. But, again, there’s other considerations in predicting how much of an impact that will [have]. In Europe they are seeing significant costs and influences, but they also have multiple products per category, for the most part, and they have a healthcare structure that’s quite a bit different and quite a bit more linear and a bit simpler than what we face in the United States. Here, there’s contracting and rebates, and all of these other components that go into pricing that I think becomes more of a challenge and harder to predict. At least my perspective is that you really have to think more broadly, you have to think longitudinally and not quarterly, “This is my bottom line this quarter,” but looking more longitudinally about say, [if] I’m a payer or a physician, ultimately, what’s going to be the best for the patients, including their costs as well as their treatment. 

Now if we assume, like we’re saying that biosimilars really are clinically no different, then thinking about some of those other considerations is important for our patients. Again, it comes down to having evidence to support that, to trust the biosimilars. 

Cate Lockhart, PharmD, PhD, discusses when she believes the industry will start seeing biosimilars driving down cost of drugs. 

Cate Lockhart, PharmD, PhD: Biosimilars and Price Competition

What are some ways in which biosimilars are like generics?

That’s true they’re not generics, but I think what people fail to realize or fully appreciate is that “no clinically relevant” difference. So, my PhD is in pharmaceutics so from a pharmacokinetics stand point a biologic— the innovator biologic– has quite a lot of variation within a single batch from lot to lot. But there’s really– you can keep taking that same innovator biologic, even though it’s going to be a little different than the last dose that you had, probably, or there’s a risk or chance there would be some level of variation. It’s probably not a lot of variation, but it is there, and you don’t see a clinically different response. 

It’s the same story with biosimilars. There’s going to be variation, there’s going to be variation within the biosimilar lot. There’s going to be variation between it and the reference product to some extent within the threshold, but the exact same thing is true with generic drugs. There’s less variability within a lot in generic drugs, but the variation between the original branded small molecule drug and the generic is still within the threshold. So, it’s not identical ultimately, [but] there is a threshold and it’s really the same story with biologics that there’s variation anyway, but it doesn’t manifest itself in any clinically relevant way. 

 

Cate Lockhart, PharmD, PhD, explains the similarities and differences between generics and biosimilars.
 


Cate Lockhart, PharmD, PhD: Similarities Between Biosimilars and Generics

So at Sandoz we're just so thrilled with the experience. We have 20 years' worth of experience in biologics, 340 million patient days of exposures to biosimilars in 86 countries. We are so excited for the value that we can bring to Americans. They so deserve getting access to these important products, both from us and from our industry colleagues, in order to free up capacity for the new innovations that are coming, but also, and importantly, to get the benefit of the savings and increased access that they'll have.

Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, explains what about biosimilars excites the company. 

Interviews