Sarfaraz Niazi, PhD, an adjunct professor of biopharmaceutical Sciences at the College of Pharmacy at the University of Illinois at Chicago, discusses how the COVID-19 (coronavirus) pandemic is affecting drug shortages, challenging the FDA, and creating an greater opportunity for biosimilars down the road.
Safaraz Niazi, PhD is an adjunct professor of biopharmaceutical Sciences at the College of Pharmacy at the University of Illinois at Chicago.
The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia here today on behalf of the Center for Biosimilars®. I'm welcoming Safaraz Niazi, PhD, an adjunct professor of biopharmaceutical Sciences at the College of Pharmacy at the University of Illinois at Chicago. Is there a role for biosimilars in treating patients with Coronavirus?
Niazi: I think just like any map, certainly, I think we're finding out that some of these maps can be used to stop the cytokine rush, and others may in fact be directly responsible for increasing the activity of the body's immune systems. The answer is absolutely yes.
CfB: How could we address international supply chain problems by fostering biosimilar manufacturing in the United States?
Niazi: Well, at the moment, there is not a major issue. When we sit outside of the US supply, [and] I'm including Europe to be a consistent supply, most of the raw materials, or anything, are not imported from any country like chemical genetics. So, I don't see any reason why there should be any shortage of biosimilars during this pandemic or crisis; nothing is [being held] back for the companies to make it if they've been already making it.
CfB: Why do we need to be concerned about the quality of agents including biosimilars manufactured overseas?
Niazi: [This is a] big concern. [A] huge concern. FDA will never have enough ability to monitor all of the quality of the products made outside of the [United States]. Especially nowadays, I'm sure all the inspections are on hold and there are so many of them [that] are coming in. [It] is absolutely not possible for FDA to monitor it. Just about every company that is supplying to [the United States] has received warning letters. So, my take is that we've got to start making some of the more critical product in [the United States]. For [this] simple reason, the FDA has a better legal control over the US companies than they have over any foreign company.
CfB: Will the Coronavirus pandemic foster greater opportunities and greater momentum for biosimilar uptake in the coming months?
Niazi: I think so, because now we are realizing that there is a need for products that could possibly help. And we are finding out now that biologics are maybe the only way. If there is a treatment or there is a possibility, it's not what is commonly reported in literature today. It's going to be the monoclonal antibodies. So, yes, I think there will be a lot of new applications of some of the biologics and we'll see a new wave of indications coming out for drugs, which then will be transformed into biosimilars which is an automatic transition that will take place. So, yes, I see a huge role. This is a new awakening for us. We have a new life for biosimilars.
What is happening to biosimilar R&D amid the pandemic? Well, like every other business, everything is literally on hold today. Some companies have shut down totally, others [have] said they're working on it. There is no doubt in my mind that we are looking at a 6 to 9 month delay in everything they're doing, and I don't think anybody can deny that.
CfB: What may happen to sales efforts for new biosimilar launches?
Niazi: Oh, that's an interesting one. You know, every company is losing money today, and I think they will lose a lot more; especially, [there's a] concern for the stakeholders, hospitals, and other places where they buy biosimilars, or they use biological products. There will be a big rush to see how we can cut the cost down. And I think there's no better way of showing that if the biosimilar suppliers come up with reduced cost, I think the adoption will increase significantly. But not only for any of these reasons. It's the cost, and it is a lot more critical today than it was yesterday.
CfB: So, currently, there are 6 to 8 biosimilar applications on review at the FDA currently, and these may be delayed another 6 to 9 months. So, just to follow up on that answer, what is happening behind the scenes at the FDA with respect to biosimilar application approvals?
Niazi: You know, it's known widely that FDA is still operating, but one of the key elements of any biosimilar application is FDA inspections. Generally, you're talking about 2 or 3 inspections before FDA will license a product and all of them have been put in a hold. And I don't know exactly today how long will the hold go on, but my prediction is that the 5 or 6 or 7 products that are in the pipeline or in the terminal stage of approval will be delayed about 9 months or maybe up to a year.
CfB: And lastly, do you have any other thoughts on biosimilars in the current pandemic?
Niazi: Well, I think biosimilars are a good cost-effective option. And when the world economy has gone into a spin, it's a free fall, literally, if you want to call it that. I think when we all come back from this pandemic, OK, everybody will be looking forward to saving money. In my opinion, biosimilars will offer the best opportunity to get into [the] market for no other reason [than] because of the cost [savings] that they bring to the stakeholders. So, I'm very positive about a bigger adoption of biosimilars after the pandemic.
CfB: Thank you, Dr Niazi.
Niazi: Most welcome, indeed.
CfB: To read more, visit the centerforbiosimilars.com. I'm Matthew Gavidia. Thanks for joining us.