We had the opportunity to speak with Christine Simmon, the public face of an organization that has long championed the biosimilar industry. Our conversation covered topics from the worst-case scenario in the State of Texas v. USA to oncology biosimilar uptake and AAM’s current priorities.
Biosimilars Review & Report: What’s the one thing about the biosimilar industry today that surprises you?
Christine Simmon: That’s a great question. I would say that it’s really heartening to see the level of determination and engagement of the industry with policymakers and stakeholders to advance patient access to biosimilars. Initially, most of the engagement was on the regulatory side, which is understandable. It took a while for the agency to come out with guidances that were important for those seeking biosimilar approval. I recall going to many conferences where much of the focus of our work was on the regulatory side.
Biosimilar manufacturers have shown great savvy in the current climate of concern around prescription drug prices. They’ve capitalized on that by demonstrating the value proposition of biosimilars and educating a wide range of stakeholders about their critical role driving down prescription drug costs and overall health care costs, and delivering patient access. That was sort of a surprise and a very pleasant one.
BR&R: We seem to have reached a point today where new biologic patent litigation has plateaued—settlements with manufacturers are being reached faster than new lawsuits against biosimilar makers are being filed. Do you believe the biosimilar manufacturers have attained a good handle today on the patent questions and challenges they can expect and whether to participate in the patent dance?
Simmon: Certainly, biosimilar manufacturers have learned much over time about patent litigation and the patent dance; at the same time, both of these have evolved. I would never underestimate the endless creativity of patent lawyers seeking to protect their clients’ monopolies and exclusionary periods.
I don’t believe that biosimilar manufacturers and their legal teams can ever really rest on their laurels. More likely, litigation will ebb and flow based on which biologics become more widely available through biosimilar launches and which ones have patents that are ripening for challenges. I certainly wouldn’t recommend being complacent around the litigation landscape. It’s always evolving, it’s always a challenge, and it’s always expensive. And it’s still a critical barrier to biosimilar access.
BR&R: Do you think we reached a point where average time to market after FDA approval will start to decrease?
Simmon: It depends. It is product specific and very specific to the patent thicket situation for that product. Some manufacturers have and may continue to invest in biosimilar product portfolios and others may never pursue their proposed products because of the patent landscape, patent thickets, and the litigation costs associated with that. It will depend on the company’s level of financial resources they can devote to continuing that slog through patent litigation and also potentially their ability to reach pro-competitive settlements with the reference biologic manufacturer. As we have seen with biosimilar adalimumabs for Abbvie’s blockbuster Humira—which will enter the market 11 years earlier than the expiration of the brand’s patent—settlements can accelerate biosimilar competition and access for patients.
INCENTIVES AND EDUCATION
BR&R: With that in mind, what are AAM’s top priorities today in terms of biosimilar advocacy?
Simmon: Our top priority continues to be strengthening patient, provider, and payer incentives to increase biosimilar utilization. That includes several of the pending pieces of legislation as well as actions the administration can take (particularly around shared savings).
We remain, of course, committed to education of all stakeholders and to our anti–patent abuse platform, which pertains particularly to biosimilars. There’s no shortage of priorities. Overall, increasing biosimilar utilization is really priority number 1.
BR&R: Let’s talk a bit about the shared savings question. Do you actually have to be in an ACO or other alternative care model environment to benefit from the differential reimbursements that the federal government is trying to implement? The reason I ask that is most organizations are not in shared savings context right now. Will the increased ASP-plus reimbursement move the needle on biosimilar utilization in those medical groups?
Simmon: Well, the current proposal is to raise the provider reimbursement from ASP + 6% to ASP + 8%, even though we recognize that with financial sequestration, this is really only ASP + 4.3%. It’s helpful, but at best it’s a Band-Aid. It will not move the needle longer-term.
That said, we do support the legislation to increase the provider reimbursement. We do appreciate that bipartisan policy makers are engaged and supportive of this.
It helps further the conversation and the education platform. In terms of significantly increasing uptake and utilization, shared savings is likely to be more effective and for a longer term, as we have seen in the European Union and Canada.
BUILDING ONCOLOGY BIOSIMILAR UPTAKE ON PREVIOUS EXPERIENCE
BR&R: Do you anticipate that the uptake of cancer treating biosimilars like trastuzumab and bevacizumab will be faster than that of other launch classes?
Simmon: I do think the oncology class in particular is poised to really breakthrough in terms of biosimilar uptake. The cancer community more than most has been very supportive of biosimilars, based on the savings and access they bring to patients with cancer. Stakeholder groups like the American Cancer Society Cancer Action Network, CancerCare, and Oncology Nursing Society Cancer Care Network have been extremely engaged with us and have been powerful education and advocacy partners. Their providers are well educated. Their patient advocacy groups are well educated. They seem very eager to embrace biosimilars. Uptake of this class is likely to be faster, because there’s such a strong foundation in the oncology community.
Their providers are well educated. Their patient advocacy groups are well educated. They seem very eager to embrace biosimilars. Uptake of this class is likely to be faster, because there’s such a strong foundation in the oncology community.
BR&R: Is the experience they’ve already had with the supportive oncology medications like filgrastim one reason?
Simmon: Yes, and the utility of these products is supported by real-world evidence. Oncologists have been using these biosimilars in their practices. That’s very helpful. Not to mention, having a spokesperson like Dr. Sameer Awsare from Kaiser Permanente—who is a highly visible leader on not only oncology biosimilars, but biosimilars generally—has been particularly helpful with education of medical professionals.
BR&R: In a way, the granulocyte colony-stimulating factors were almost an entry level type of therapy for the hematologists and oncologists, to help them gain that comfort level with biosimilars. Unfortunately, that is not the case for the autoimmune category. The rheumatologists, dermatologists, and gastroenterologists cannot “get their feet wet” to help them understand the nature of biosimilar infliximab, etanercept, or adalimumab.
CAN WE QUICKLY PASS BPCIA AGAIN, IF NECESSARY?
BR&R: Does State of Texas v. USA keep you up at night?
Simmon: The BPCIA is a small part of the Affordable Care Act (ACA). That said, this is not the first challenge to the ACA. There have been many. The most recent Supreme Court decision was in King v. Burwell (2015), which involved the validity of the individual mandate. I still have the faded headline clipped on my bulletin board. Even at that time, concern about the BPCIA was not widespread, because conventional wisdom was that in a negative decision, the BPCIA would be resuscitated immediately by the Senate and the House. That’s likely the same scenario today.
I don’t believe there’s any intent in any of the ACA challenges to derail biosimilars or roll back the 351(k) approval pathway. So, no, it really doesn’t keep me up at night.
BR&R: I’ll share what keeps me up at night: Unintended consequences. I agree completely that it’s very likely that the BPCIA would be deemed severable. It’s fully encapsulated within the ACA and not part of the intended function of the larger legislation. Yet, if the ACA is struck down, we will depend on Capitol Hill to refile and reapprove the legislation in its entirety, while resisting the urge to attaching some other legislation to it or making an attempt to “improve” certain aspects of the BPCIA. This could delay reimplementation and/or cause important, unforeseen effects down the road. Any significant delay can freeze the marketplace. That’s the kind of thing that worries me.
Simmon: That’s very valid, but it would have worried me more years ago. However, if the legislation has to be reintroduced and quickly passed, the risk of something like an increase in marketing exclusivity to 14 years (from 12) or some other type of provision is slightly lower I believe —not because there aren’t interests who would certainly push for that, but because the climate on prescription drug pricing has changed. There is a stronger willingness today to discount advocacy efforts that will result in higher drug costs.
This administration has certainly done more, at least rhetorically, acknowledging the value of biosimilar competition. Look at the passage of the CREATES Act, which targets drug pricing in a helpful way. That was extremely bipartisan. Many sponsors, strange bedfellows, and stakeholder alliances worked together to pass that legislation. Also, the successful adoption of the USMCA without provisions to increase our trading partners’ exclusivity periods for biologics. That was a big victory for biosimilar competition.
BR&R: In 2025, will there be more biosimilar manufacturers as members of AAM or fewer, based on the challenges biosimilars face today and the successes we’ve seen in bringing their products to market.
Simmon: More! That’s my prediction.