Part 1: Swaminathan P. Iyer, MD, Discusses Need for Biosimilars in India, US

The Center for Biosimilars^® (CfB): Hello, I'm Matthew Gavidia. Today on the MJH Life Sciences Medical World News, The Center for Biosimilars^® is pleased to welcome Swaminathan Iyer, MD, professor of medicine in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center. Can you just introduce yourself and tell us a little bit about your work?

Iyer: Thank you, Matthew, for the opportunity and introduction. I'm Swami Iyer. I am a professor of medicine at the University of Texas MD Anderson Cancer Center and my area of work is in hematological malignancies, particularly in lymphomas and T-cell lymphomas and I'm happy to be here.

CfB: To start us off, can you please tell us about the importance and the difference biosimilars and generics have made for improving access to medication in both India and the United States?

Iyer: Absolutely, I think, Matt, before I say anything, I always have to profess that whatever I say is my opinion and as we take care of patients with basic conditions like lymphomas, we often need to have medications that are potentially lifesaving. Obviously, we work with a lot of partners and stakeholders, if you will. So, there's a lot of people [involved]. We’re trying to work our way through the ecosystem so that these drugs are available to the patient. The focus on the patient is the center of this whole ecosystem.

That being the case, I think the most important question you asked was the role of biosimilars. So, a lot of research has been done and a lot of new medications have come out of that, and accessibility to those new medication is the question at hand. There used to be the world of chemotherapy 20 to 30 years ago, which would kill a lymphoma and at the same time affect the patient by causing a lot of side effects. I think it definitely still has a place, but now we have come out with smarter medications such as pills, IV [intravenous] medications, antibodies, immunotherapies, and CAR T [chimeric antigen receptor T-cell] therapies. So, all these are more finely tuned versions that do only kill the lymphoma and in theory have few side effects on the patients.

That being said, these research advances that have happened also bring a lot of costs and these medications are expensive. Finding these new medications, integrating biology, and doing clinical studies has a lot of expense attached to it. So, when these new medications come out, there's a lot of cost attached to it. And oftentimes, patients don't have access to this for one reason or another, whether it's a result of not having insurance or if they have insurance, the insurance companies may not be in a position to approve it right away even if it's an FDA-approved label.

The first 5 to 10 years of a new drug is always challenging for various reasons. Yes, it is a lifesaving option for many patients but in some ways, it’s a "haves and have nots" situation that comes up, and that shouldn't be the case. Everybody who has lymphoma, no matter what their background is, should have access to these medications. In that context, the role of biosimilars and generics is very important. Biosimilars and generics have made an impact and have been able to bridge the gap.

We took a snapshot of that situation, particularly in a very small subset of cancers called lymphomas and CLL [chronic lymphocytic leukemia], where we actually looked at the availability of biosimilars and generics in that disease entity by listing all the medications available in the [United States] and India. It's much easier once the originator comes along for you have the ability to come up with copies or have generic versions of them. So, I think with cancer it will be very similar to what happened in the HIV era. In the HIV era, the virus was rampant, just like it is now in the current pandemic and it was also sort of a pandemic in its own terms where patients needed medications and out came these generics, which made a huge difference. I think, hopefully, we can get there with cancer drugs as well.

CfB: How would you address the concern among drug originator companies that such solutions will not enable them to recoup a reasonable return on their investment?

Iyer: As I said earlier, it's an ecosystem. Everybody has a part to play in trying to bring the drug to life, so to say. You have to go through the trials and tribulations of regulation, clinical studies, marketing, and whatnot. So, the cost that is involved in doing that and how they're going to recoup that I think is the concern that companies have. In some ways, these are aspects of the global multidimensional approaches that we take.

When companies come out with new drugs, they have to go through an approval process. The FDA approves the drug. The FDA does not tell you what the price of the drug should be. There is nothing in the United States that tells you what the price should be so, the companies do their own due diligence on the market. Then, that's when the market forces come to play and when they subject the pricing to that aspect. Now, you can talk all about the macroeconomics and microeconomics aspects of it, but I'm not qualified to do that. My job is to see how we can bridge the gap.

That being said, we are able to create opportunities for everybody. And I think drug companies, at least in the United States, are able to do this in some ways by creating foundations and getting free drugs for patients. So, they do fill some gaps, especially for the ones without insurance and there are situations where they cannot do anything.

For example, if it's Medicare or Medicaid equivalent insurance companies, they may or may not be able to help out in many ways depending upon the complexities of insurance that the patients have. There are lots of areas that they could do a better job and I think they are trying to do that but like everything else, you need a quarterback to push this through. And that's the situation of the United States. And the companies want to retain that ability to bring in the costs that they spent in developing this drug.

But when it comes to beyond the United States, I think it's a little different. I think the companies take a different approach because a lot of countries have their own ways of regulating things. In Europe, they regulate the prices differently, as each country has its own pricing. Many countries, like India for example, have their own modalities. Japan has its own approval process. So, every country is different.

Now, if it's a global company, I would think that they would think about trying to recoup the cost, but at the same time, I think they are also in a position to understand that the access to progress is just as important, based on some of the precedents that have happened in India with the use of Gleevec [imatinib], for example.

So, I think that's one large precedent that has created the ability to allow some of the generics and also biosimilars in countries like India. Now, I think that leads that process in many ways. And the laws are very different [in India] compared to here and that's the reason they're able to do it. We can always question if they're right or wrong.

So, whether the companies here in the United States are able to recoup the cost of that, I think clearly the answer would be no, they're probably not going to be able to do that. But in other regulated markets, they are able to look into it and are able to think about how they can do it.