Part 2: Sean McGowan on Ensuring a Future Competitive Biosimilar Market

To watch part 1 of this interview, click here.

The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life Sciences™ Medical World News, CfB is pleased to welcome Sean McGowan, senior director of Biosimilars at AmerisourceBergen. What do you advise biosimilar manufacturers or developers about working through these obstacles to get their products to market and build up a sizable share?

McGowan: No, it's a great question. And, you know, at a company like AmerisourceBergen, where not only do we do drug distribution, but we have hub services for providers, or we have a payer consulting group that can advise on how to contract appropriately for whichever specific market they're operating in, manufacturers need to approach this market specifically around biosimilars in the same way that the innovator companies have brought these products to market.

So, if a specialty company launching these products contracts with the same customers that the innovator company has, they have to figure out what their payer strategy is going to be, how they're going to promote their product into the different classes of trade, how they're going to promote this product to their physician group, how they're going to have to promote this product to their hospital health systems. So, it's really about coming to market the same way that the innovator product did but provide that level of commercial activity and match that of the innovator company.

It also depends on the type of portfolio in that company that's bringing the biosimilar to market, what type of portfoliao already exists for them. Are they operating in the same markets that their biosimilar is going to be operating in? Do they need to introduce themselves? Do they need to go out and market themselves and garner the level of trust that existing companies already have with customers in that space? It can be easy for some companies that have a legacy, whether it be in the oncology space, or the supportive care space, or in the inflammatory or the anti-TNF [tumor necrosis factor] space. It's much harder for organizations that are new to market that don't already have that recognition in that space. And so, depending on the level of confidence and comfort that those customers have with a specific manufacturer, [that] will determine how much activity that they have to put out and operate in to gain that level of trust and confidence with those end customers.

CfB: Experts tend to doubt as much biosimilar product variety can compete side-by-side as has occurred with generics. Physicians can't stock all of these products. What's your opinion?

McGowan: So, this is the interesting challenge that probably wasn't really thought about until we had a multisource situation for a lot of these markets. If you think back to the summer of 2019, prior to the first oncology products being launched into the market, there were only 2 or 3 biosimilar markets where there were multiple biosimilars plus the reference product competing there. It was something that didn't really need to be addressed at the time. But since those first oncology biosimilars products have come onto the market—we had 2 that launched in July of 2019—since then, we're up to, I believe, 9 oncology biosimilars products in the 3 main oncology markets including Avastin [bevacizumab],Herceptin [trastuzumab], and Rituxan [rituximab].

So, I think it's a good thing that we have a multisource situation, where we have great legacy manufacturers that know how to manufacture and bring specialty and biologic to market right. So, it's creating choice and access for customers and patients, which is a really good thing. These products are coming to market at a significant discount from a WAC [wholesale acquisition cost] price basis compared with that of the innovator product, which is really good thing, that's going to help create access, affordability, and drive cost savings not only for customers but for physicians and patients, most importantly.

But it does create a level of added complexity that didn't really have to be dealt with prior to the launch of these biosimilars. So, what we're hearing from our customers is that, yes, this is a bit of a challenge, where they do have a lot of choice, but having to carry multiple products can create a certain level of additional work, maybe potentially some additional carrying costs.

But largely, what we're hearing from our customers is that as they figure out how to leverage their EMRs [electronic medical records], the technology, and the workflows within their practices or in their health systems, that it's something that they can manage. I'm not saying that it's easy, but it's something that they can manage. I'm no saying it's easy, but it's something that they can manage. And so, for us as a distribution partner and a commercialization partner, our first goal is always to create access for these products for our customer. So, ensuring that we always have access to the products from the manufacturer. How do we work with the manufacturers? How do we contract appropriately. How do we gain access to these products?

And then, with the customers—again, going kind of going back to the education pieces—[it's about] educating these customers on what products are available, what classes do they fall in, what they are indicated for, and then how to access those products through AmerisourceBergen.

So, that's something that we do and work very closely with our customer account teams to ensure that everybody is up to speed and up to date on the what the market looks like and what products are available. And then, we work with those downstream customers to really understand, do they have preferences on the products that they want to purchase? Do they have specific relationships, or do they have specific preferences as far as the manufacturer that they want to work with work or utilize? And then also having that deeper conversation of understanding that that medical benefit or that payer is going to dictate, to a certain level, of what products need to be utilized, understanding what that payer mix for those customers looks like.

For example, if you get a customer that, you know, has 70% commercial lives walking through their doors and they have 3 major payers that cover those lives and each of those payers are going to require a different, let's say, trastuzumab. So, that Herceptin [reference trastuzumab] market, that now has 5 biosimilars in them, so you have 5 biosimilars plus the innovator, you have 6 products to choose from and you've got 3 different payers that have 3 different formulary requirements as far as what products can be used. So, it creates a little bit of additional work there.

But what we're hearing from customers is that as long as they're able to update their order sets, integrate this information in their DMRs [device master record] appropriately, and leverage the prior authorization department that are calling on these health plans to ensure that these products are covered, as long as those workflows are working properly and appropriately, they can absolutely address those issues.

CfB: Is there a solution that ensures the most robust price competition within a biosimilar drug category?

McGowan: That's the $10-million question that I think the industry is working to address in a very thoughtful manner. I've seen kind of the proposals out to CMS [ Centers for Medicare and Medicaid Services] around some shared savings models that are being presented, which I think is an interesting path to be going down. I think it's one that absolutely needs to be looked at and analyzed and figured out. I think that can be a good path there as long as it's not detrimental to the levelof reimbursement that the physician practices would experience. We don't want to drive reimbursement down so much that it puts a lot of financial pressure on these oncology practices.

I think, and it's something that we've talked about a lot in the past, what you'll hear from a lot of biosimilar manufacturers is encouraging the payers and the commercial plans to cover all biosimilars at parity with the innovator product. So, in other words, don't disadvantage the biosimilar products against an innovator and don't block the ability for customers to utilize these products. In my mind, I think allowing parity, leveling the playing field, and allowing these products to be covered at the same rates as each other and as the innovator product is going to do a couple of things. It allows free market competition to happen. It allows the manufacturers to compete, as they normally would, without having to put out additional value into the into the marketplace that would otherwise hurt them.

And I think most importantly it provides a level of choice that puts that choice firmly in the hands of the physicians and patients. I think the most frustrating point around the payment models and the coverage models for biosimilars, that we hear from our physician classes of trade in the oncology space and rheumatology space, as well as the hospital systems, is that they feel like the choice is being forced upon them as opposed to them making the choice in partnership with their patients, which is something that these physicians absolutely want to be able to have by choice and not be forced into it.

So, in my mind, I think parity coverage for these products is probably going to be the best, most complete answer, but it's really nice to see that there is some thought being put out in some alternative payment models, like the shared savings model that is currently being proposed.

Part 3 of this interview will be available October 4, 2020.