6 Predictions About Biosimilars In A Hospital Setting

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Biosimilar commercialization has been a significant topic of discussion at a number of conferences over the past year. As more biosimilars are approved in the U.S., it’s important to keep a close eye on the market’s evolutions and how biosimilars end up in doctors’ and patients’ hands. I took the opportunity to speak with Dave Picard, VP of biosimilars and injectables for AmerisourceBergen, which is one of the largest global pharmaceutical sourcing and distribution services companies. Because of AmerisourceBergen’s close relationships with manufacturers, providers, and pharmacies, Picard offered valuable insight into current market dynamics and how biosimilars will fit into current hospital distribution models.

Anna Rose Welch: Do you think the biosimilar market will more closely resemble the innovator or generic markets?

Dave Picard: Prior to their launch in the U.S., biosimilars were expected to be treated as a category of medicines in between an innovator brand and a generic. I think it’s clear today that they are being viewed more like a brand in terms of the cost-savings they provide to healthcare in general. This trend will likely skew more towards the generics side once additional competitors enter on each specific molecule, but it will never quite get there. At least it shouldn’t, given the level of investment needed, for instance, in patient services to support these products on the market. I think as subsequent launches of the same molecule occur and the competition increases for that particular molecule, the market will start to look more generic-like. Now that the FDA has released guidance, interchangeability could also push biosimilars toward a more generic-like status.

Welch: Do you expect interchangeability will be the “silver bullet” for biosimilars’ commercial success?

Picard: The success of interchangeability ultimately depends on the product and whether the medicine is reimbursed through the pharmacy or the medical benefit. Interchangeability is likely going to be more impactful for pharmacy benefit products. In the hospital, physicians can use any product regardless of whether it has earned an interchangeable designation. In fact, we’ve seen some of the big hospital group purchasing organizations (GPOs) bid for filgrastim and choose between the biosimilar and innovator without the molecules being interchangeable. My feeling is that once we see interchangeable products enter the market, we’ll see a switch in who has the power in these decisions. Right now it falls with the pharmacy benefit managers (PBMs). But post-interchangeability, retail pharmacists may be able to make those decisions without contacting the prescriber in certain states. In addition, wholesalers could prioritize a certain manufacturer’s product on its prospective formulary.

Welch: What incentives do companies need to offer in order to earn market share for their biosimilars?

Picard: I think if a biosimilar company attempted to bring a biosimilar to market without a full complement of patient assistance efforts, it would be a very tough road. Without a level of services over and above what innovators are offering, the competitive factor lands on price, which is one of the hurdles to making it in the biosimilar space. Because a biosimilar company cannot claim an improved efficacy or safety profile for its biosimilar, they really can only compete on price. Therefore, I think a good best practice is to get in front of providers. But instead of showing up and saying, ‘Here is my product, here is my price,’ it’s best to approach providers early and inform them of what you’re planning on bringing to market. Ask them if there is something different — a volume or form of a drug, for example — that they are not currently seeing and would like to see.  

Welch: How do you expect biosimilars will fit into current distribution models to hospitals?

Picard: When it comes to innovator drugs, about 95 percent of them are delivered to the hospital via full-line distribution. This means a hospital will receive a single shipment once, or perhaps twice, a day, containing all the meds from various manufacturers that they ordered from a wholesaler.

There is also the option to go the route of specialty distribution. We actually saw Genentech switch to specialty distribution for Avastin, Herceptin, and Rituxan. This move, however, was not preferred by the hospital, as it involved sourcing those drugs from six specialty distributors, which resulted in additional supply chain costs and a loss of wholesaler discounts. Though this move could be considered a competitive, protective measure, it could also be a competitive disadvantage should another company go the wholesaler route. For instance, I think if a biosimilar filer were to come to market with a Genentech biosimilar, for instance, and offer to do a full-line distribution model, they’d have a distinct advantage. I think most biosimilar manufacturers are contemplating the appropriate distribution approach. But I’d argue that going with the full-line distribution model is the least disruptive and most efficient. Most hospitals prefer this method of receiving products, as they’re efficiently and economically delivered to the facility. It’s beneficial to the manufacturer to work within the hospital workflow to get its product into more places and increase access. Similarly, the hospital economics for a biosimilar product are better, as wholesalers can push through cost-savings in a full-line model.

Welch: How does AmerisourceBergen plan to incorporate biosimilars into its distribution models?

Picard: We’ve recently announced our decision to launch a biosimilar formulary. While still in its early stages, this will be similar to how we manage the generics space as well. We carry all the generic manufacturer’s products of one particular drug, but we preference the one that’s on our formulary. For biosimilars, interchangeability is a big factor when it comes to making decisions related to the new formulary, as approvals will come at different times for different products. Further, two biosimilar products may be interchangeable with the same reference product, but not with each other. We’ll need to take into account those details on how interchangeability will be evaluated and approved – expected to be clarified in a final guidance by the FDA later this year – as we build our formulary.

We’re particularly excited to see how things play out in the oncology space, since we have a particularly large footprint and have built close relationships to the community practices and providers in that space. We feel these connections will help shape the oncology biosimilar formulary decisions and encourage greater use in community practices, as well.  

Welch: What suggestions do you have for biosimilar makers looking to get their biosimilars into the hospital and to secure competitive market share?

Picard: Biosimilar manufacturers who are seeking market share should watch the whole market, not just a segment. For example, manufacturers should consider the sizes, doses, and forms of the biologic innovator product markets and provide those variant products to patients. Similarly, if a product is dosed by weight, manufacturers would be remiss to not include all weight class considerations. Even slivers of the market represented by smaller patient populations could be meaningful for a biosimilar’s overall market share.