Women's Health Series: Biosimilars Interview Part 1

In part 1 of this series, Dr. Mallampalli sits down with Drug Topics® to discuss biosimilars as a treatment option for chronic health conditions and their impact on women’s health.

Monica Mallampalli, MSc, PhD: So, as regarding my background, I'm actually a trained biomedical scientist. I have my PhD in human genetics, but then I've also been trained in the fields of cellular, molecular biology and biochemistry.

So, I left research several years ago, and moved into science policy. And over the past, over a decade, I've been focused on advancing advocating for advancing women's health as well as women's health research.

Monica Mallampalli, MSc, PhD: The mission of healthy women is to educate and inform women ages 35 to 64, that's midlife women. That's an age [group] that we believe are underserved. That's the time when women are in premenopausal stage, are prone to chronic conditions.

We believe that educating and informing those women, providing them with the information that they need, will allow them to make better decisions for themselves and their families. And also, that's the age where women are taking care of their children, their families and their aging parents. So So really, our mission is to educate and inform them and empower them with information so they can make better decisions.

Drug Topics®: That's incredible. That sounds like very important work. Can you tell me a little bit about what a biosimilar is and how this is connected to women and the group of women that Healthy Women reaches out to and serves?

Monica Mallampalli, MSc, PhD: Yeah, so before I explained what a biosimilar is, let me also explain what a biologic is, because there's still a lot of confusion and not, not much understanding of the terminologies.

So, a biologic is something that's derived from natural sources. So this could be a protein or nucleic acid or sugars that are derived from either human cells, animal cells, or microorganisms.

They are unlike the simple chemical drugs, they're very complex and what we call are certain modifications on these large molecules. We don't really sometimes understand what their structure is, but we know how they function.

So, those are biologics. And biosimilars, if you take an equal into maybe a branded drug versus a generic, you can put it in those towns, but they don't really correlate. But again, we take a biologic and you now try to make a similar medicine, which functions the same way as the biologic. So we don't know how it may look, but at least it's been tested and we know it functions the same way. That's what is called biosimilar.

So far, we have had 31 biosimilars approved, I believe the last one was approved in July. And some of them when it comes to women's health, there are biting five that have been approved for breast cancer.

And they've been few, I believe, about 10 or 11 that have been approved for chronic pain or actually autoimmune conditions, I should say, not really chronic pain, autoimmune conditions such as rheumatoid arthritis or I take arthritis, Crohn's disease.

The reason I see them as being more important for women's health, because those are the conditions, especially rheumatoid arthritis, psoriatic arthritis, in fact, affects more women, especially women of midlife women.