Julie Reed of the Biosimilars Forum shares her key goals for the organization in her new role

Improving access and pushing through major legislative changes for biosimilars are just a few of the many plans that Julie M. Reed, the new Executive Director of the Biosimilars Forum, has for the organization.

Transcription:

What do you hope to accomplish for the Biosimilars Forum and the biosimilars industry in your new position as Executive Director?

Reed: This position is such an honor. I was chosen and invited to represent the industry in the United States. And the Biosimilars Forum is the leading voice of the biosimilars industry. It is the only trade association that focuses solely on biosimilars and we are the go-to for policymakers and regulators and anyone interested in biosimilars. So, for me, it’s an honor. Our members are diverse, they are the leaders of biosimilars in the world. They have the biggest portfolios, the most biosimilars in development. So, it’s an incredible honor for me.

I think with our Board of Directors, our goal continues to be to increase the uptake of biosimilars in the United States. And we have a long way to go and there are a number of things that need to keep progressing and happening. The first is access. We need better access and greater uptake of biosimilars. It’s interesting, when you think that biosimilars are cheaper, but uptake is low, and CMS has to decide whether or not they can cover expensive new drugs and innovations, like Alzheimer’s drugs. , or decisions where we talk about price trading policies. And here we have a biosimilar on the shelf and we’re like, “Guys, you’ve got the solution here. Just use them. Use them more! Facilitate, encourage the use of biosimilars.” And you did that, the savings paper. It was between 38 and 120 billion dollars and in 5 years, it is consistent with all the economic papers. It’s as if lower cost biosimilars and higher utilization lead to savings. And it’s an amazing solution that needs support.

So that’s one of our biggest things. We know from our global experience that policymakers and payers need to encourage the use of biosimilars early on because people are reluctant to switch. So let’s go and we’ll work with our stakeholders and decision makers to continue to proactively push for incentives to change the market. To achieve cost savings, we need a change in behavior.

The other element is to follow through on President Biden’s executive order. We continue to work with HHS and call on them to implement policies, like shared savings or $0 co-payments and things like that, that they can do now and follow to be proactive about presidential decrees for biosimilars. Again, we have a readily available solution to reduce costs. It is competition in the free market. We need our stakeholders and our ecosystem to support it. So this is one of the access rooms.

Outside of government, we seek and continue to work with our payers, private and commercial payers, to ensure and demand forms of equal or equal access to all biosimilars. Exclusive agreements discourage patient choice, physician choice, competition from biosimilars, and the stronger the competition, the lower the prices. So we’d like to see our payer community embrace every biosimilar on the market and put them all on their formularies, not just 1. So that’s a piece.

Next, we offer user fees. Next week will start 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 biosimilars program from the FDA is key, of course, for our industry and for 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’d like the FDA to implement them because delay in inspection means delay in approval. So we need the agency to look into that.

But we’re also excited about user fees because one of the key user fee initiatives will be a regulatory science program. And this is important for our members because as you know, next year we will see the first adalimumab (that word that kills me) but the first Humira [adalimumab] biosimilars coming to market. And so the agency’s regulatory science agenda is critical to us and we want to see great progress in this area, it will be agency industry that will dialogue and create new policies and processes to move forward and evolve this science in the development of biosimilars. I’ll date myself, but we’re almost 20, over 15, in biosimilars. I think I was at Hospira in 2008 when we launched Retacrit [epoetin alfa-epbx; referencing Epogen/Procrit]. Thus, the science and requirements for the development of a biosimilar have evolved.

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

We will continue to work on misinformation. We continue to see misinformation about biosimilars and are constantly monitoring this at the Forum. And we work very closely with the FDA and the FTC, after our workshop, to make sure that if we see something, they are aware of it, because we think it is very important for patients, doctors and consumers. not to have false information about biosimilars. They should all know that they are safe, high quality and FDA approved. We don’t want to scare. And then we’ll continue to work on all the barriers to access and things like that. So, it’s exciting, to be here from the beginning, to be here now in this new role, it’s just, I’m very excited about it.

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