Lindsey Mulrooney

Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.

What should the FDA be doing to address the current backlog of inspections for biosimilar manufacturing facilities?

So, as we finished negotiations for the user fee, after that, we found out that biosimilar inspections were quite delayed. And unfortunately, if there's a delay in an inspection, there's a delay in approval of a biosimilar. And the biosimilar program inspections were the lowest—a little bit over 60%. So, we have multiple probe biosimilar applications that are not approved because the FDA did not do the inspection. Now, [we] completely understand about COVID-19, everything else, but what we're doing is advocating for the FDA—as part of user fees—we're advocating for the FDA to address this in a couple of ways.

One, FDA has a plan to do remote inspections. We're asking them to be sure that biosimilars inspections are always treated equitably, that we're not put on the bottom of the list and we're not deprioritized, and to use the process and procedures for remote inspections. The COVID-19 pandemic was tough, but we do believe that this won't be our first, unfortunately.

The other piece about the inspections, as we have heard from the FDA in our meetings, is that they plan to get all of the inspection backlog completed by the end of this year for fiscal year. So, we are cheering them on and also going to hold them accountable to do that, and especially with biosimilars because they're so important for patients and like we said cost savings. But yes, that's a key piece for us, to get those inspection backlogs up to date and completed for biosimilars.

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Julie Reed On How the Biosimilars Forum is Helping FDA Catch Up on Biosimilar Inspections

Julie M. Reed, the executive director of the Biosimilars Forum, explains what needs to be done to ensure progress on biosimilar legislation and lower drug prices.

Lowering drug prices seems to be the one issue Republicans and Democrats can agree on but efforts to do so, including ones that could increase biosimilar access, are often stalled. What needs to happen to get these policies implemented?

They need to be prioritized and we need action. When we have opposition against these bills, we hear from policymakers that they’re hearing the market’s working fine. That is, there's depth—several different lenses to look at how the market is doing. The market is working where there's robust competition and access because you're seeing that competition and access lower the prices and you're getting greater cost savings. That's the goal here.

Where the market is not working is if you don't have access or don't have robust coverage of multiple biosimilars; you are not seeing the robust pricing competition and cost savings. So, I think it's very important that when it has bipartisan support. We’re leaving cost savings on the table—and billions of dollars in cost savings. And I think we're not the only ones shouting this from the hilltops. Academics are shouting it, researchers are shouting it, legislators are shouting it, patient groups and providers are shouting, like, “Help us get access to biosimilars because we need to treat our patients and we need to have cost savings!” And so, we need action. We need the action, and I hope we see it.

Julie Reed Explains How to Push Forward Bipartisan Biosimilar Legislation

Although a lot of discussion regarding biosimilars has focussed on patient access, we need to divert more attention to the reliability of companies making biosimilar products, said Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis.

What types of conversations regarding biosimilars do we need to be have more of?

Patient access, we've heard a lot about. The other thing that we'd heard less about probably is the issues around surety of supply, which you get through having multiple manufacturers. But it's also an issue where you need to know that the companies sponsoring the products are reliable. And that's where I'd put one pitch in for Samsung Bioepis as if you've done the science right from the beginning, then everything else is an opportunity. And if you've got state of the art manufacturing. So, an issue that came out of COVID-19, of course, is reliability of the drug supply. And so you need to have capacity and you need it to be reliable.

Gillian Woollett Speaks on Where Biosimilar Conversations Need to Go Moving Forward

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discussed the different options that payers have to manage the growing number of biosimilars referencing Humira (adalimumab) that are expected to enter the market in 2023 and beyond.

How do you think payers are going to manage having so many adalimumab biosimilars to choose from?

That's what we do as a company: we help people make formulary and drug management decisions. So, I see there's 3 options. As a payer, you can stay with AbbVie’s [product] all the way, which avoids member disruption and makes things more smooth but you don't get biosimilar adoption. And from an optics perspective, I think adoption of biosimilars is becoming more required these days.

So, one option is AbbVie, all in. You may not get quite as much savings as going with biosimilars, but you also now don’t have some of the hurdles and hassles you get with going with biosimilars.

Number 2 is going middle of the road. Keep Humira [reference adalimumab] on formulary, but also add some biosimilars at parity. So, have both options available. It allows you to maintain some Humira rebate and also allows you to take advantage of some biosimilars savings. So that's option 2, kind of meeting halfway.

And then the last one is biosimilars, all in. Take [Humira] off formulary and go all in with biosimilars. Try to convert as much of the market share as you can.

So, those are the strategies, and as far as all those different options you probably add the [originator], and/or 1 or 2 of the biosimilars, and then see how the cards fall.

How Will Payers Manage Multiple Adalimumab Biosimilars? Jeffrey Casberg Explains

The Biden administration must follow through on its promises, and Congressional leaders must do more to push through bipartisan biosimilar policies to encourage better adoption and lower drug costs, according to Julie M. Reed, the executive director of the Biosimilars Forum.

What sort of policy initiatives should legislators and the FDA be putting a greater focus on?

This is really the critical year, and we need the administration to follow up on the President Biden's executive order to do more with biosimilars; it's almost a 1-year anniversary. So, we need CMS to get some biosimilar programs out there. We've been talking for a long time and they're leaving cost savings on the table. [It's] really important, especially now.

So, that's one piece of it; the administration needs to act and follow up. In Congress, biosimilars have been a bipartisan solution for a number of yours. But unfortunately, politics have stopped some of our ideas and that are supported, as I mentioned, by both sides in the House and in the Senate. [Reimbursing at] ASP [average sales price] plus 8%, shared savings, and $0 copay. Those things need to happen, especially with the [adalimumab biosimilar] launches next year and [the biosimilars] launching in ophthalmology. We've launched a interchangeable insulin biosimilar. All these products are coming to fruition, yet patients don't have access to them.

And so, we need the administration and Congress to do something. The other piece, about the FDA, we, as stakeholders and partners with the FDA, have to get the BsUFA [Biosimilar User Fee Amendment], the super 3 pac that's critical, and then we have to partner with the FDA to to evolve the program through the science regulatory science program. So, that's really key. And then continue, like I said, our partnerships with the other agencies, like the FTC, the FDA, and CMS, to do everything we can to make us more successful.

Lindsey Mulrooney

Julie Reed On How the Biosimilars Forum is Helping FDA Catch Up on Biosimilar Inspections

Julie Reed Explains How to Push Forward Bipartisan Biosimilar Legislation

Gillian Woollett Speaks on Where Biosimilar Conversations Need to Go Moving Forward

How Will Payers Manage Multiple Adalimumab Biosimilars? Jeffrey Casberg Explains

Julie Reed: Biosimilar Policies Legislators Should Be Prioritizing