Originally published in Biosimilar Development
In the first installment of this four-part series, the members of the Biosimilar Development Editorial Board and friends discussed how 2019 turned out for the biosimilar industry. But as we face 2020, several big questions remain from the past year and about what the future may (or may not) bring for the industry. Here, these 19 experts pose their biggest questions for the new year, as well as how they anticipate or hope these questions could be answered.
What is the biggest question you have going into 2020? Are there any solutions in the works (i.e., government policies, stakeholder partnerships, market launches, internal developments at your company/organization) that could address these questions?
The biggest question facing the Canadian biosimilar market is if and when other Canadian provinces and territories will follow in British Columbia government’s footsteps. One encouraging sign was the 2019 Alberta government budget which explicitly called for the expansion of the Biosimilar Initiative, which many across the country interpreted as the implementation of a transition program in line with that in BC. Indeed, following the release of this budget, the Alberta government announced it would be implementing its own biosimilar transition program. The government’s decision will hopefully create the momentum for other provinces to follow in uniform fashion, thus creating a strong movement towards a biosimilar-first approach that involves transitioning.
The other major question that remains is how the private payer market will respond to the growing trend towards biosimilar-first policies. A few insurers, including Green Shield Canada, have publicly announced support for biosimilar-first policies that support transitioning, but the vast majority of the insurers have continued to offer patient choice of biosimilar or originator products within the confines of product listing agreements that non-transparently lower the price of the originator to biosimilar price.
Ned Pojskic, Leader, Pharmacy & Health Provider Relations, Green Shield Canada
The biggest question I have for 2020 is how are the upcoming oncology launches in biosimilars going to do? There are some products coming that are true, core oncology medicines that treat the cancer itself and not, for example, the side effects of chemotherapy. With oncology being the leading therapeutic area in branded pharmaceuticals and, in turn, for biosimilars, how much uptake will there be?
There are of course topics of interest within the biosimilar firm’s space, such as the chosen channel strategies and the pricing tactics — all to manage the complex web of stakeholders that influence not only the flow of product but of the dollars, too. But there are also those things external to the biosimilar firm, such as the originator’s counter-moves, payer and channel tactics, pricing reactions, and lifecycle management. It will, therefore, be of great interest to me to not only see how such core oncology products fare but also what we can learn from such experiences to ensure each successive launch in biosimilars only gets better.
Edric Engert, Managing Director, Abraxeolus Consulting
Depending on the country, there remains a general lack of political support for biosimilars adoption. Though there are many ways to incentivize a transition on the patient side of things, a simple solution would be telling patients they will be reimbursed based on the lowest biosimilar price. This means, if they want the reference compound, the difference will be paid out-of-pocket.
Francois-Xavier Frapaise, M.D., ClinExcel
The main question in 2020 is whether any institution can address the challenges I described in Part 1. Politicians from both sides of the aisle have made efforts to lower the high cost of drugs. Can Congress pass legislation that facilitates biosimilar entry? One piece of legislation being considered would limit the number of patents that biologic manufacturers can raise in litigation. Before being amended, an early version of a second law would have given the Federal Trade Commission authority to challenge “unfair methods of competition” under Section 5 of the FTC Act for conduct related to “patent thicketing.”
The FDA is also well-positioned to act. In its Biosimilars Action Plan, the agency promised to (1) “[i]mprov[e] the efficiency of the biosimilar and interchangeable product development and approval process”; (2) “Augustaximiz[e] scientific and regulatory clarity for the biosimilar product development community”; (3) “9evelop effective communications to improve understanding of biosimilars among patients, clinicians, and payors”; and (4) “[s]upport market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.” Achieving these goals would significantly assist biosimilars in reaching the market.
Michael Carrier, Distinguished Professor, Rutgers Law School
I wonder about bigger changes in play that can (and will) impact biosimilar adoption. Our move towards value-based care is like pushing a big slow-moving boulder going uphill. But, getting that boulder up there and securing it so it stays there will address much of what ails us in healthcare, including the slow uptake of biosimilars. I want to see all hands on deck to push that boulder!
Lauren Vela, Senior Director, Pacific Business Group on Health
2019 was an election year for the European Parliament, and the new European Commission was recently appointed. This means that in 2020 the plans and strategies will be put in motion. The European Commissioner for Health has been tasked to support “European Member States in constantly improving the quality and sustainability of their healthcare systems.” The mission letter also insists on the importance of balancing the “supply of cost-efficient medicines” and “the European pharmaceutical industry to ensure it remains an innovator and world leader.” This represents an opportunity to shape future-proof biosimilar and access frameworks.
Among new, pressing topics, we will focus more on future access to biosimilar medicines. We have evidence and proven track records of both broader access and earlier access, as medically appropriate, to biologic therapies across the EU with existing biosimilars. Future biologic portfolios going off-patent over the next 10 years display very specific features, such as smaller patient population size, which create new challenges in designing a multi-source environment. The current development requirements and market access frameworks are not adequate for non-blockbuster biological medicinal products. Therefore, there’s a need for regulators, policy makers, and healthcare stakeholders to engage in a dialogue to design a conducive framework for biosimilar competition as part of the next step in the life-cycle of innovative biologic therapies.
Julie Maréchal-Jamil, Director Biosimilars Policy & Science, Medicines for Europe
Key question – will the biosimilar market further advance in terms of uptake in 2020? Will stakeholder confidence in biosimilars continue to evolve and improve?
Seeing one or more of the legislative bills get signed into law would be an important milestone in 2020. This would signal that Congress is committed to a robust biosimilar market and provide evidence that different stakeholders will see real incentives to use lower cost, high-quality biosimilars. This would also signal to stakeholders that biosimilars are an important tool to help drive down overall spend and can serve as a viable option for patients.
Molly Burich, Head of Public Policy, Boehringer Ingelheim
Celltrion’s biggest question heading into 2020 is whether there are any innovations or new approaches we can take further beyond biosimilars.
In Europe, Celltrion is ready to launch its subcutaneous (SC) formulation of Remsima, an innovative infliximab, to provide an effective treatment option that could address the unmet needs of patients. By providing an administration option that was previously not available for patients and physicians, we believe that the SC formulation has the potential to be a premium biosimilar treatment option that not only allows patients to have more control of their treatment and enjoy their daily lives, but also significantly impact physician treatment choices. SC formulation could also offer additional value by reducing the time and cost spent traveling to infusion clinics and the burden on healthcare systems.
In the United States, we believe that the introduction of the two oncology products Truxima (rituximab-abbs, biosimilar to Rituxan) and Herzuma (trastuzumab-pkrb, biosimilar to Herceptin) will contribute to addressing unmet needs of U.S. patients.
HoUng Kim, Head of The Medical and Marketing Division, Celltrion Healthcare
Our biggest question is whether we will see more liberal formularies with inclusion of biosimilar agents as first line therapy. We have demonstrated how value-based contracting can accelerate biosimilar uptake and allow physicians some control over formularies. We hope that with the Office of Inspector General and CMS better defining the Stark Law and safe harbor regulations, there may be similar opportunities with Medicare plans next year.
Colin Edgerton, MD FACP FACR, Executive Chairman, American Rheumatology Network
Will this be the year that biosimilars really take off in the U.S.? There have been numerous discussions with politicians about options to encourage the uptake of biosimilars. Solutions mainly concern government policies for both Part B and Part D drugs, including elimination/reduction of patient co-pays, favorable formulary placement, increased physician reimbursement, as well as the formation of a CMS star rating for institutions that make biosimilars available. Doctor and patient education will also help increase confidence in using biosimilars and underscore their importance and necessity in decreasing overall health care costs.
Sue Naeyaert, Consultant, Former Global Government Affairs, Policy, and Pharmacoeconomics, Biosimilars, Fresenius Kabi
When will the U.S. market see its first interchangeable biosimilar? As more states have adopted automatic substitution laws, it seems that the market incentive to pursue interchangeability is there. Moreover, FDA earlier this year issued final guidance on establishing interchangeability. With both of these pieces of the puzzle now in place, it will be interesting to see whether biosimilar manufacturers pursue an interchangeability designation for their products in the coming years.
Alexandra Valenti, Partner, Goodwin Procter LLP
The biggest question going into 2020 is how the U.S. will step up to the plate to strengthen the biosimilar market. 2020 marks 10 years since the enactment of the BPCIA, and the U.S. has yet to maximize the value offered by biosimilar medicines. There have been promising successes, particularly the growing number of FDA approvals and market acceptance of short-course and supportive care biosimilars.
Overall, however, the U.S. has failed to embrace and champion biosimilar medicines through practical policies that align systemic incentives to drive biosimilar competition. Policies exist that put biosimilars on a ‘level playing field’ with originator biologics, but the status quo is inherently biased towards originators, so a ‘level playing field’ is still fundamentally imbalanced.
There are policies on the table that could address pieces of this puzzle, for example, provider shared savings for biosimilars or eliminating patient out of pocket costs. The challenge is that there is no ‘silver bullet’ and the complexity of the healthcare system perpetuates barriers to a successful biosimilars market and the associated gains in patient access and system sustainability.
Erika Satterwhite, Head of Global Biosimilars Policy, Mylan
Legislative solutions abound regarding drug prices in general and biosimilars specifically, but gridlock in Washington also abounds. Many questions exist:
- Gottlieb has left the FDA, so a biosimilars champion may be missing.
- Pay-For-Delay is prevalent, and anticompetition regulators need to intervene.
- Legislation is needed to prevent patent evergreening, to reduce the number of patents that can be claimed, to codify and prevent “patent thickets” and “patent hopping,” and to streamline the steps involved with the so called “patent dance.”
- Nomenclature is still a problem; why is a suffix not required to be applied to the innovator’s non-proprietary name?
- Legislation should be considered that would reduce the patent exclusivity for new biologicals from 12 years to five (or some reasonable compromise).
- Many drug pricing bills are awaiting some action; indexing prices to international markets and limiting price increases to no more than 10 percent/year are examples.
Ross Day, Consulting Hospital Pharmacist, Former Director of Pharmacy, Vizient
Regulatory convergence (EU)/ harmonization (U.S.) must continue so that we can get as many biosimilars approved as efficiently as we can and available in as many markets as possible. Then they can compete on their merits. After all the reference products are the same across the world, so the biosimilars to them should be able to be the same too.
Biosimilars cost around 100X the average generic to get approved. This is a substantial investment, so we also need to better understand how biosimilars succeed where they do if those investments are to continue. This allows more informed choices by sponsors. However, absent the commercial “pull,” I expect to see more biosimilar portfolios trimmed, and that is not a good sign for a sustainable competitive specialty market in the U.S. mitigating price increases for the mid and longer term.
By being late in the U.S., we do benefit from the massive experience elsewhere. The good news is that all the expectations about how biosimilars will behave are based on sound regulatory science, established since 1996, and they are living up to that promise. There have been no unusual or unexpected clinical results with biosimilars – how phenomenal is that! We need that message out there and heard most especially by patients and their healthcare providers.
Gillian Woollett, Senior Vice President, Avalere Health
For our small company, the biggest question we face in 2020 is how successful we’ll be in partnering with larger companies to enable us to advance biosimilars into and through Phase 3 after we have largely and successfully de-risked them in Phase 1.
Why are we still requiring Phase 3 confirmatory studies? Phase 3 trials represent the single biggest barrier to entry for biosimilars, and we have the experience telling us that no candidate biosimilar that passed Phase 1 ever failed Phase 3 — so when can we start having a conversation about eliminating this unnecessary burden? How can the FDA and EMA harmonize regulatory requirements for biosimilar approval?
Noelle Sunstrom, CEO, NeuClone
It remains to be seen in 2020 what concrete steps will be taken to counter biosimilar misinformation and disparagement. Biosimilar misinformation and disparagement are being promulgated by companies and a few other organizations. The Novartis comments of July 16, 2018 to HHS and the Pfizer Citizen Petition of August 22, 2018 identified some, but certainly not all, examples of biosimilar misinformation and disparagement.
One prominent example of misinformation are statements opposing what is called “non-medical switching” that oppose transitioning stable patients from reference medicines to biosimilars. Anyone who opposes switching of existing, stable patients is effectively stating that biosimilars are appropriate to use only for new patients, and that existing patients should remain on the more expensive reference medicine. Although “non-medical switching” is a catchy phrase and has a simplistic appeal to those who are wary of biosimilars, there is no science behind the term. The data package supporting every U.S.-approved biosimilar to date includes information showing that the safety and efficacy of therapy is unchanged when transitioning from the reference medicine to a biosimilar. Opposition to “non-medical switching” is an insidious form of misinformation because it claims to be scientific and have the best interests of patients in mind. But in fact, it is neither. It would be helpful if a clarification and supporting information on this issue is included in the new patient-focused materials that are under development by the FDA.
Another example of misinformation are statements that “no interchangeable biologic” has been approved for a given originator, which implies that no biosimilars have been able to meet this standard. But if the reference medicine is administered only in hospitals, clinics, and physician offices and are not dispensed at pharmacies, the concept of interchangeability (pharmacist-initiated substitution without prescriber intervention) does not apply. Companies will not bother seeking an interchangeability designation for such biosimilars. Stating that there is no interchangeable biosimilar for such reference medicines is extremely misleading.
The battle against biosimilar misinformation and disparagement is important to provide the public with the truth. This in turn will increase confidence in biosimilars and lessen the “bioscary” and fearful messaging that seeks to slow acceptance and uptake of biosimilars.
Hillel Cohen, Executive Director, Scientific Affairs, Sandoz
Will Scott Gottlieb’s replacement(s) at the FDA continue to lead efforts to promote biosimilars? As FDA commissioner, Gottlieb appeared to be a champion of biosimilars that the industry desperately needs at that position. While not every policy or guidance of his agency was biosimilar friendly (e.g., naming and interchangeability), he seemed passionate about creating competition and criticizing tactics used to delay launches with the hopes of working with the FTC to stop patent plays. Will newly appointed commissioner Stephen Hahn pick up the mantle and keep them as a priority? That remains to be seen.
Matthew Harman, PharmD, MPH, Director of Pharmacy, Employers Health
This coming year will prove the viability of the biosimilar market more than ever before. We’re finally going to see multiple entrants for the same reference product. For example, there will be up to five biosimilars competing not only with Genentech’s biologic Herceptin but also – and potentially even more importantly – each other by the end of 2020. These are the dynamics that will allow us to see whether competition of biosimilar products can really support affordability and access for patients.
There are also opportunities for groundbreaking government policies to provide greater incentive for prescribing. The Prescription Drug Pricing Reduction Act, slated for Senate review, contains the provision that biosimilars could receive a higher rate of reimbursement than reference products. The Act would temporarily increase the reimbursement for biosimilars from six percent of the reference product’s average sales price (ASP) to eight percent of the reference product’s ASP for a period of five years beginning in 2020. Thus, if this act passes, it would give prescribers more incentive for using biosimilars.
With increased competition within the market as well as the potential for increased incentive through reimbursement, 2020 could be a pivotal year for biosimilars.
Rick Lozano, VP, Biosimilars & Integrated Business Development, AmerisourceBergen
One stakeholder group that increased their level of support for biosimilars in 2019 was employer groups, including self-insured employers.
My biggest question is how these groups can be engaged in 2020 to help further realize the potential $54 billion in savings over 10 years that biosimilars can provide the healthcare system.
For example, will they help design plans that reduce patient out-of-pocket cost share for biosimilars so employees can further share in the savings provided by biosimilars? Will they work with their health plan to better understand the utilization of biosimilars relative to the reference product? Will they engage their health plan to ensure that there are no disincentives for providers to use biosimilars? Will they more actively share their voice on various policies supporting biosimilars that have been included in proposed legislation?
I believe that employer groups who think biosimilars are a solution to addressing healthcare costs can be a major force to help drive these activities in 2020. From a biosimilar manufacturer perspective, Sandoz will continue to be actively involved with providing education to this important stakeholder group to help ensure a better understanding of biosimilars and to grow confidence in their safety and efficacy.
Brian Lehman, MBA, MHA, RPh., Director, Medical Account Management and Strategic Alliances, Sandoz
Novartis Services Inc. Comments on HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) https://www.regulations.gov/document?D=CMS-2018-0075-2757 (accessed Nov 19, 2019)
Citizen Petition from Pfizer Inc. https://www.regulations.gov/document?D=FDA-2018-P-3281-0001 (accessed Nov 19, 2019)
Mulcahy AW, Hiavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Santa Monica, CA; Rand Corporation 2017. https://www.rand.org/pubs/perspectives/PE264.html. Accessed on November 11, 2019.