Kathy Oubre, MS, chief executive officer of Pontchartrain Cancer Center, explains the progress she has seen regarding biosimilar utilization and acceptance.

What sort of gains have you seen for biosimilars over the course of the past year and where do you see this going in 2022?

Our biosimilar market in the US remains in its infancy, but it is growing. And if you review the bodies of literature out there, NCCN [National Comprehensive Cancer Network] did a poster presentation early in 2021 that showed that for the therapeutic agents, they saw the most rapid adoption of the Herceptin [trastuzumab] biosimilars out of all of the biosimilars to date. And it was for patients who were on treatment or new to treatment. It showed this massive increase in access to care, and i also showed a cost savings to practices in patients. And then we continue to see those types of anecdotal evidence, or hard evidence, shown in that NCCN poster presentation. you know, Ronny Gal with Bernstein did an analysis  in 2021. Again, narrowing that same thing: that biosimilars are playing a large role in helping to bring down and stabilize health care costs and increase access to care.

The COA [Community Oncology Alliance] biosimilars data are showing that same thing. It's 122 community oncology practices across the US and 2.4 million administrations. That's a lot of covered lives. And so, the US market is in its infancy, but it's really showing progress and maturity. And if you also then look at what it's doing with ASP [average sales prices] and Medicare allowables, it's doing its part in helping to bring down health care costs, without sacrificing quality.

I think we need to continue to believe in the biosimilars market and do what we can in working with our payers and our members of Congress and CMS to foster a healthy biosimilars market.

Videos

Kathy Oubre Shares Her Take on How the US Biosimilar Market Is Maturing

Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis as well as an Advisory Board member for 

®, summarizes some of the presentations, including her own, from the Festival of Biologics conference that was held in San Diego, California.

What presentations at the Festival of Biologics did you enjoy checking out and what do you hope to see more of at future conferences?

It was an interesting meeting, of course. With FDA, it's always important to see what they're doing. Unfortunately, they have a travel ban. So, they weren't in person, but there were videos. And they had some nice updates. I mean, there's a certain preoccupation with user fees, because it's critical to the funding of the FDA. But in general, I think it was just a catch up for everyone. And FDA also had a session on biosimilar educational materials. So, those are worth checking out on their website. They've done a lot of work on that over the last year or so. So, they were flagging some of those presentations. And I think more than anything, it was just catching up with progress. And of course, everybody anticipating 2023.

To reference to the title of your presentation at the Festival of Biologics, what does global progress with biosimilars mean for the United States?

So, what was interesting on that is there's the presumption that the US is late. But the US is only late in the sense that some of the IP [intellectual property] issues that have meant that products were approved later and launched later. But the science in the US has always been somewhat ahead, given that FDA led the world with comparability. So, it was both a discussion that the US is ready as a scientific and regulatory matter, but also that we're going to have this interesting opportunity of experience from elsewhere by the time those same biosimilars are approved in the US. So, there was a discussion around real world evidence, the fact that there has been no case of any unusual or unexpected adverse event with any of the biosimilars approved in Europe or the US. So, that was all good news. And then the issues are around, of course, the appearance of delays, but I think the FDA is ready. And some of the arguments about more efficient development and perhaps reductions in the clinical trials, the confirmatory head-to-head clinical trials, are being led by Europe too. So, if you've got the experience and you've got the clinical trials done, there's progress towards global reference. I think there's an expectation of opportunities for efficiency all around.

Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis, reviews some of the presentations, including her own, from the Festival of Biologics conference.

Gillian Woollett Recaps the Festival of Biologics 2022

Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer Center, previews her upcoming presentations at the Festival of Biologics conference.

You are going to be speaking at Terrapinn’s Festival of Biologics conference happening in March. What are you going to be discussing and what can audiences look forward to?

I will be doing a panel presentation with

Sean McGowan [AmerisourceBergen]; Bhavesh Shah, RPh, BCOP; and Craig [Burton] from AAM [Association for Accessible Medicines]. We're doing the keynote on the first day, and we'll be discussing present and future considerations for the biosimilar industry. We're going to be doing a much broader kind of a 30,000-foot discussion, and in that, will talk about the current biosimilars market products and some industry milestones: where we started, where we are now, and we are going to be looking forward. We will discuss what we see coming as far as launches and what's going to be happening in the space within the next 6 months, the next year, the next 5 years. And then we'll be having probably a fairly robust discussion regarding the regulatory constraints and some policy implications around biosimilars.

Additionally, on the third day, I will be doing a panel presentation with Melody Chang, RPh, MBA, BCOP, at AON [American Oncology Network] and we'll be discussing the importance of biosimilars within the oncology landscape and kind of a crystal ball discussion of where we see biosimilars in oncology moving forward.

Kathy Oubre Previews Festival of Biologics 2022 Discussions

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.

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

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 

, 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.

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

Julie M. Reed, the new executive director of the Biosimilars Forum, gives a timeline of her career in the biosimilars space and what led her to be one of the founders of the organization.

You are one of the founders of the Biosimilars Forum. What was it about biosimilars that got you involved with this line of work in the first place?

So, I'm old and I've had an incredible career, where my first job was as a clinician and then as a hospital administrator and nursing home administrator. Then I moved over into pharma. And I've always been mainly on the generic drug side. And then, as I developed my career in government affairs and policy, I was with Hospira. Hospira was one of the first biosimilar companies in the world. My CEO and the board decided that biosimilars and creating a biosimilars pathway was a major strategic goal. And so with my health care background, my generic drug background, and my working with patients and seeing the cost of health care, it was quite an honor to be to be tapped on the shoulder and say, "Julie, our strategic priority is to develop a biosimilars pathway and we we want you to go do that."

So, I been there from the beginning, not just in biosimilars in the United Staes and lobbying to get the BPCIA [Biologics Price Competition and Innovation Act] passed, I've also worked around the world helping to develop the pathways and launched biosimilars in Europe and Japan and everywhere where nobody knew what a biosimilar was; it was a new word. Can you imagine? And we had to tell everybody what it meant and what it was about and how policies had to change.

I was, I hope, a driving force and continue to be a driving force in seeing that happen. So, it's a passion of mine, and it's been an incredibl amount of fun.

The Biosimilars Forum's Julie Reed Catalogs Her Long Career in Biosimilars

The Global Healthy Living Foundation is a volunteer organization that works to improve the lives of individuals with chronic conditions. Given that, the group has a natural interest in seeing improvements in patience access to critical medicines, such as biosimilars, which are equivalent to reference biologics and can help bring down the costs of treatment.

In this interview, Tony Hagen, senior editor for The Center for Biosimilars®, talks with Robert Popovian, PharmD, MS, who serves as chief science policy officer at GHLF, about a recent podcast series the group did to promote wider understanding of biosimilars. Popovian provides his impressions of progress toward biosimilar availability in the United States and the value of biosimilar education for patients and providers.

Popovian is also vice president of Health Economics and Policy for ConsenSys Health and a senior health policy fellow at the Progressive Policy Institute. To access the podcasts on biosimilars produced by GHLF, use this 

As chief science policy officer for Global Healthy Living Foundation, Robert Popovian, PharmD, MS, has a bird’s-eye view of some of the central issues of biosimilar access in the United States.

Robert Popovian, PharmD, MS, Discusses Biosimilar Progress and Education in the United States

The Center for Biosimilars® interviewed Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute (PRI) and director of PRI’s Center for Medical Economics and Innovation.

Winegarden said that although he does not know what exactly goes into biosimilars manufacturers’ strategic decision making regarding prices, he believes that biosimilars need to enter the market at a 50% to 60% discount in order for them to have the greatest chance of commercial success. A more conservative discount closer to the reference product prices is going to lead to a slower uptake of the biosimilar. He said that he hopes for larger discounts when etanercept and adalimumab biosimilars enter the US market so that they can take more of the market share quickly.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, discusses his predictions for etanercept and adalimumab biosimilar pricing and why he hopes manufacturers will offer them at large discounts to reference biologics.

Wayne Winegarden, PhD, Discusses His Predictions for Etanercept, Adalimumab Biosimilar Pricing Discounts

Karen van Caulil, PhD, is the president and CEO at Florida Alliance for Healthcare Value.

Why is an uptake in biosimilars use important to oncology patient care, and what struggles has your practice faced to make it happen?

We've been educating employers about biosimilars almost the whole 10 years that I've been [at Florida Alliance for Healthcare Value], maybe 8 years. There has been very limited uptake. There have been a lot of barriers to that happening, whether that's the reference product company putting up barriers on their end, or maybe it's the health plan and the [pharmacy benefit manager]. The rebates have been a challenge as well because the employers like to get those rebates from the reference product. We've educated them about how, even when you look at the amount of the rebate, it might still be better to offer that biosimilar. And then, oncologists have said, “Hey, there's a bunch of different biosimilars for certain products and it's an inventory issue. So, we can't afford to stock all of these different biosimilars with the hope that they'll be utilized.”

We're really working hard to find a way to encourage that uptake, because the manufacturers have told us [they] may not continue to manufacture them if there isn't more significant utilization, and it looks like there's about 30% to 40% savings in most cases. I will caveat that there are instances where the reference product might actually be less expensive based on how that drug is administered. A lot of the coalitions [and] a lot of the employers are working hard to get this to happen, and we really thought it would have worked through long before now.

Karen van Caulil, PhD, president and CEO at Florida Alliance for Healthcare Value, discusses the difficulty her institution has had in getting providers and employers to switch to biosimilars.

Karen van Caulil, PhD, on Biosimilar Uptake in Oncology Patient Care

The Center for Biosimilars® interviewed Steven Yates, MD, a medical oncologist and medical director at Intermountain Healthcare in Las Vegas, Nevada. Three years ago, Intermountain hired him to lead its biosimilar adoption effort.

Dr Yates explains how critical nurse navigation is for all aspects of oncology, which can make explaining clinical and symptom information to patients easier. He said that nurses can be a valuable resource for patients for explaining complicated concepts, especially in regard to treatment selection. Yates also discussed his experience with the nurse navigators at his practice and how patients have an easier time contact them than their providers. Nurse navigators can allow for patients to be more in touch and informed on their care needs between office visits. Yates said it's important for patients receiving oncology therapy to be in contact with health care institutions in some capacity and that nurse navigators can also keep providers informed on any issues the patient is experiencing.

Steven Yates, MD, explains how the relationships that nurses have with patients can influence biosimilar acceptance. 

Dr Steven Yates Weighs How Relationships Between Nurses, Patients Influence Biosimilar Acceptance

Dr Yates describes Intermountain’s experience with switching patients to biosimilars vs initiating biosimilar treatment only for biologics-naïve patients. Early on, Intermountain did not switch patients from reference products until their course of therapy was complete. Intermountain is now 100% biosimilar focused, Yates says. Strong patient support is employed to build acceptance for biosimilars, and patients are asked for consent prior to a biosimilar switch. Yates says the institution has experienced little pushback, and the resistance that has occurred has been mostly over reimbursement issues, where patient assistance programs have preferred use of reference products.

Steven Yates, MD, discusses Intermountain Healthcare's policies surrounding switching patients from reference products to biosimilars.

Interviews