The Biosimilars Forum's Julie Reed Shares Her Major Goals for the Organization in New Role

Improving access and getting big legislative changes for biosimilars passed are just some of the many plans that Julie M. Reed, the new executive director of the Biosimilars Forum, has for the organization.

Transcript:

What do you hope to achieve for the Biosimilars Forum and the biosimilar industry in your new position as executive director?

Reed: This position is such an honor. I have been chosen and asked to represent the industry in the US. And the Biosimilars Forum is the leading voice of the biosimilar industry. It is the only trade association solely focused on biosimilars and we are the go-to for policymakers and regulators and everyone about biosimilars. So, for me, it's an honor. Our members are diverse, they're the leaders in biosimilars around the world. They have the biggest portfolios, the most biosimilars in development. So, that's an incredible honor for me.

I think with our board, our goal continues to be to increase the uptake of biosimilars in the US. And we have a ways to go and there's a number of things that have to continue to progress and happen. The first one is access. We need greater access and greater uptake to biosimilars. It's interesting, when you think about biosimilars being lower cost, yet the uptake is low and CMS is having to make decisions on whether or not they can cover new costly drugs and innovations, like Alzheimer's drugs, or decisions where we're talking about price negotiation policies. And here we have a biosimilar sitting on the shelf and we're like, "Guys, you've got the solution right here. Just use them. Use them more! Facilitate, incentivize the use of biosimilars." And you guys did this, the paper on the savings. It was between $38 to $120 billion and in 5 years, it's consistent with all the economic papers. It's like, lower cost biosimilars and higher uptake lead to savings. And this is an incredible solution that needs support.

So, that's one of our biggest things. We know from our global experience, policymakers and payers need to incentivize the use of biosimilars in the beginning because people are reluctant to change. So, let's get out there and we're going to work with our stakeholders and policymakers to continue to proactively push for incentives to change the marketplace. To get to the cost savings, we need a change in behavior.

The other piece is to follow up President Biden's executive order. We continue to work with HHS and call on them to implement policies, like shared savings or $0 co-pays and things like that, that they can do right now and follow up to be proactive on the President's executive orders for biosimilars. Again, we've got a readily available solution to lowering cost. It's free market competition. We need our stakeholders and our ecosystem to support it. So, that's one of the access pieces.

Outside of government, we're looking and continue to work with our payers, our private and our commercial payers, to ensure and call for parity or equal access formularies to all biosimilars. Exclusive agreements discourage patient choice, physician choice, biosimilar competition and the more competition, the lower the prices go down. So, we would love to see our payer community embrace all the biosimilars on the market and put all of them on their formularies, not just 1. So, that's a piece.

Then we're coming up with user fees. Next week kicks off of the third round of BsUFA [Biosimilar User Fee Amendments of 2017], BsUFA III. And so, the hearings start next week, but really having a strong robust FDA biosimilars program is key, of course, to our industry and to our members. So, making sure the FDA has adequate resources, has the ability to focus on biosimilars, has the ability to do inspections even during a pandemic. They have some great ideas, but we would love to see the FDA implement that because the delay in an inspection results in a delay in approval. So, we need the agency to look at that.

But we're also excited with user fees that 1 of the key initiatives in the user fees will be a regulatory science program. And this is important to our members because as you know, next year, we'll see the first adalimumab (that word that just kills me) but the first Humira [adalimumab] biosimilars coming to market. And so, the regulatory science program at the agency is key for us and we want to see great progress in that, this will be industry in the agency dialoguing and creating new policies and processes to advance and evolve this science in the development of biosimilars. I'm going to date myself, but we're almost 20 years, over 15 years, in biosimilars. I think I was with Hospira in 2008 when we launched Retacrit [epoetin alfa-epbx; referencing Epogen/Procrit]. And so, the science and the requirements for development of a biosimilar have evolved.

We want to make sure we're in the US evolving as well. Our regulatory science program is going to help define interchangeability. It's confusing. And so, we want to move forward on that but also move forward on how can we evolve the science and evolve the development requirements because if we can lower the development requirements, we're going to lower the cost of development and so biosimilars will be at even lower costs when they come to market.

We're going to continue to work on misinformation. We continue to see misinformation about biosimilars and we are watching for that at the Forum constantly. And we work closely with the FDA and FTC, after our workshop to make sure if we see something they're aware of it because we feel that's very important for patients and physicians and consumers to not have misinformation about biosimilars. They should all know these are safe, high quality, and FDA-approved. We don't want fear mongering. And then we will continue to work on any barriers to access and things like that. So, it's exciting, to be there from the beginning, to be here now in this new role, it's just, I'm very excited about it.