From The Editor | December 23, 2020

Will These Big Biosimilar Questions Be Answered In 2021?

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By Anna Rose Welch, Editorial & Community Director, Advancing RNA

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Biosimilar Development is back with its highly anticipated second installment of its Editorial Board 2021 Outlook series! Here, these fantastic biosimilar experts address the biggest questions they have going into the new year, as well as some of the events, policies, and corporate strategies they hope will help answer these questions. It goes without saying that COVID-19 threw the entire healthcare industry for a loop. As such, it’s no surprise that one of the leading considerations amongst respondents is how regulatory agencies, pharmaceutical companies, sites of care, and patients will continue to adapt through the ongoing pandemic. Not only do many anticipate biosimilars will (finally) get the attention they deserve, there is also a focus on the policies that must be implemented by governments, regulators, and payers to ensure we take full advantage of these critical medicines.

Anna Rose Welch: What is the biggest question you have going into 2021? 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?

If the Supreme Court finds the individual mandate provision of the Affordable Care Act unconstitutional in California v. Texas, will it find the rest of the ACA severable from that provision? Because the BPCIA was enacted as part of the ACA, if there is a ruling that the rest of the ACA must be struck down along with the individual mandate, the BPCIA could be the baby that is thrown out with the bath water. But comments from several justices at the oral argument suggested that even if the mandate is struck down, the rest of the ACA could survive. We’ll be watching for a decision in the new year. — Alexandra Valenti, partner, Goodwin Proctor

We are now at the point in our evolution as an industry where channel and payor strategies and pricing tactics are being developed and fine-tuned as the market continues to develop. The biggest question I have is, will these refinements and improvements in commercialization be enough? IP continues to be an enormous risk and cause for delay. Life Cycle Management strategies by the originator and the resulting product hopping also take huge volumes away from

the reference product being pursued by the biosimilar developer. The higher concentration of Adalimumab, for example, reminds me of the case of Esomeprazole vs. Omeprazole. I used the latter as a test to see just how effective the then-prevalent managed care techniques would be at controlling costs, and they failed.  How will AbbVie do? Will AbbVie have the same luck as AstraZeneca, or has the health plan/PBM space changed enough to prevent such value shell games? 

We are currently building product portfolios, detailed product-specific sales and marketing strategies, and even commercialization infrastructure for the new norm at Abraxeolus. We can’t wait to see what happens as a result over the next few years! — Edric Engert, managing director, Abraxeolus Consulting

We have to use the collective experience of our regulators and show confidence in their decisions based on the same science being applied fairly to everyone. This is going to be hard after a tough year of battering our competent authorities — especially in the U.S. The regulators need the resources to do their jobs, which is where the re-negotiation of the UFAs is super important. They also need to have confidence in their interpretation of the science to make their decisions as expeditiously as possible — as well as the public’s respect for what they do. If the pandemic has taught us anything it is that time matters. Perhaps it is a big lift to expect all of this to change in 2021, but we should demand it just the same. — Gillian Woollett, SVP, Avalere Health

The single biggest question for the biosimilars industry continues to be how to move stakeholders beyond the status quo. There is a universal imperative to build sustainable markets for biosimilars that will continue stimulating competition in the long-term.

Even as we continue to battle COVID-19, in 2021, policymakers must prioritize policy solutions to accelerate the uptake and acceptance of biosimilar medicines over the originator such as: shared savings models with incentives directed at prescribers of biosimilars; eliminating patient cost share for biosimilars prescribed to Medicare beneficiaries in Medicare Part B; and creating utilization measures including floor thresholds for Medicare  plans to incentivize the use of biosimilars. While the BPCIA was critical in establishing the pathway necessary for regulatory approval of biosimilars, there are minimal structural incentives for providers, payors, and patients to utilize biosimilars. In fact, many legacy Medicare policies disincentivize the adoption of these lower-cost medicines. 2021 presents a significant opportunity for policymakers to modernize pharmaceutical coverage and payment programs to establish incentives that drive biosimilar uptake and enable patient access to biosimilars immediately upon FDA approval.

From a company perspective, our biosimilars strategy has been and continues to be about developing and executing on this long-term global franchise focusing on market relevance and being a partner of choice to hospitals, clinics, pharmacies, and physicians. We recognize the global need for improving access and affordability to these important therapies. At Viatris, we see healthcare not as it is, but as it should be. We believe that biosimilar medicines are a critical solution to achieve patient access to the right treatment at the right time, helping achieve better health for patients, and unlocking value for health systems. We are committed to supporting sustainable access to biosimilar medicines around the world through policies that drive efficiency in biosimilar development, combat barriers to market access, and align incentives for biosimilar utilization. — Tiffany Fletcher, Head of Global Biosimilar Policy & Access, International Affairs & Global Policy, Viatris

It’s not so much a question but a prediction for the coming year. We will hear more from employer groups. As employers continue to wrestle with providing high quality, low-cost healthcare care for their employees, employers (and their C-suite) will take a harder look at adopting a biosimilar strategy. Employers will increase their level of engagement with their PBMs, health plan carriers, and pharmacy benefit consultants to better understand the biosimilar market. They are already showing an interest in developing strategies to include the cost-savings of biosimilars in their plan benefit design. There are several clinical benefit strategies employers can utilize to improve the quality of care offered to plan participants. They will work to increase awareness and confidence of biosimilars through awareness campaigns aimed at plan participants. And, most importantly, employers will take an active role in identifying which PBMs promote greater biosimilar usage and include biosimilar provisions and competitive payment provisions within their PBM contracts. —  Kathy Oubre, COO, Pontchartrain Cancer Center

I continue to think about the challenges the industry faces with education, as patients still struggle today to understand generics’ and biosimilars’ characteristics and benefits. Physicians don’t always have the time to discuss this topic with their patients, and, depending on the indication, many may still not feel comfortable substituting a reference compound for a biosimilar. — Francois-Xavier Frapaise, ClinExcel

The worldwide pandemic continues and shows no sign of waning. Surges in the U.S. are at unprecedented levels, not seen since the days of April and May of 2020.  I’m worried that when a vaccine is finally approved, distributed, and generally available to the U.S. population, there will be enough skepticism regarding the mixed signaling from federal agencies about the approval process that significant portions of the population will choose not to participate.  Hospitals are struggling, patients have lost vast amounts of income, and biosimilars, which have been viewed as an “opportunity” for cost reductions in the past may now be viewed as “essential” in keeping hospitals afloat and providing marginalized patients with a means to life saving therapies otherwise unattainable. — Ross Day, consulting hospital pharmacist, former director of pharmacy, Vizient

The regulatory and legislative landscape will have a substantial impact on the future success of U.S. biosimilars. One area where we may see progress involves “interchangeability.” As a regulatory category unique to the U.S., interchangeability permits a pharmacist to substitute a biosimilar in place of its reference product without first obtaining permission from the prescriber. It is a regulatory designation and additional data requirement only, and not a quality designation.

Sandoz believes that the interchangeability designation in the U.S. is unnecessary and can create confusion by inaccurately implying a higher quality standard than biosimilarity — simply because it requires more data. As a scientific matter, a biosimilar is developed to match its reference medicine with regard to quality and patient outcomes, including safety and efficacy. As a result, it should be considered interchangeable with its reference medicine upon launch. — Hillel Cohen, executive director, scientific affairs, Sandoz

Our biggest question is how much further will the conversation around interchangeability evolve in 2021? We anticipate that there will be more movement on interchangeability with the introduction of insulins into the category, especially with new bills in Congress (i.e. HR 8190) signaling automatic interchangeability for these insulin products. Such legislation will help patients access more affordable treatment options, which is ultimately the goal.

If HR8190 is passed, it will be interesting to see if it paves the way for interchangeability in other biosimilar categories. This bill could accelerate the conversations around evolving the processes for filing for and/or assessing interchangeability for large molecule categories. And, it could bring more favorable attention to manufacturers that are awaiting review of submitted applications for interchangeability designation for their approved biosimilars (e.g. Boehringer Ingelheim’s Cyltezo and Pfizer’s Abrilada). — Sean McGowan, senior director, biosimilars, AmerisourceBergen

The EU has just launched its Communication on a Pharmaceutical Strategy. It aims to address key areas where medicines contribute to equal access to safe, state-of-the-art, and affordable therapies, offering therapeutic options for diagnosis, treatment, and prevention of disease. Biosimilar medicines have an important role to play in this context, and 2021 will certainly see a number of significant initiatives aimed at creating sustainable competition in the biologic market. This will draw from the existing experience captured in the IQVIA Country Score cards, but also with renewed emphasis on tackling barriers and supporting the use of biosimilar medicines by designing the right incentives framework. This is essential not only to meet the current access and healthcare system resilience challenges, but also to ensure policy frameworks are future-proofed and ready for upcoming biologic medicines set to lose market exclusivities. —  Julie Marechal-Jamil, Director Biosimilars Policy & Science, Medicines for Europe

I look forward to 2021 as the “year of the biosimilar” when multiple stakeholders finally solve the barriers to access that are preventing biosimilar uptake and make policy changes that will not only remove these barriers but also create real life cost savings for all of us.

Looking forward, there are several biosimilars policy initiatives that were initiated by Congress in 2019 and 2020 that our new Congress and Administration need to finalize in 2021 to remove the reimbursement barriers preventing uptake of lower cost biosimilars. There are several proposed ways to do this, including:

  1. In Medicare Part B, create a level playing field for biosimilars to higher cost reference biologics by increasing the ASP +6% to ASP to 8-10% for the lower cost biosimilar.
  2. Support provider adoption of biosimilars through the creation of a CMS Shared Savings Program for providers who choose to administer lower cost biosimilars.
  3. Support the FDA and FTC in taking meaningful action to stop the misinformation and disparagement of biosimilars to patients and providers.
  4. Reduce co-pays for seniors who choose to use biosimilars.
  5. Incentivize Medicare programs to utilize lower cost biosimilars through programs such as a Medicare Advantage Star Rating measuring biosimilar utilization.

There are multiple policies required to improve the uptake of biosimilars in the U.S. because there are multiple barriers to access and uptake. The solution is not a “one size fits all” answer.  IQVIA estimates that with improved access and uptake of biosimilars in the U.S., there is a potential for $100B in cost savings in the next five years. The U.S. needs healthcare cost savings, and 2021 is the year our new Congress and new Administration could achieve real cost savings by removing barriers to access for biosimilars. — Julie Reed, Vice President, Corporate Affairs Lead – I & I and Biosimilars, Pfizer

While we’ve seen important changes that support biosimilars on the regulatory front, in some cases, legislative action may be necessary to encourage broader uptake.

For example, patient groups and employers have supported ending cost-sharing for Medicare Part B beneficiaries who are prescribed a biosimilar because they recognize that, without it, patients may face access barriers. Members of Congress have shown their support for this initiative by introducing legislation, notably the Acting to Cancel Copays and Ensure Substantial Savings (ACCESS) for Biosimilars Act, which aims to eliminate co-pays for Medicare Part B patients without wraparound “supplemental health insurance.”

Coupled with other positive momentum in Congress, these efforts are promising, and I’m hopeful that we will continue to see forward movement from our federal policymakers. — Brian Lehman, MBA, MHA, RPh., Director, Strategic Alliances & Patient Advocacy, Sandoz

Celltrion’s biggest question heading toward 2021 is the impact of COVID-19 on the biopharma industry and how to tackle COVID-19 while not hindering patients’ treatment journeys. We believe the crisis could be an opportunity for us to rebuild and reshape the healthcare system.

The coronavirus pandemic has changed the treatment landscape entirely; there has been an increase in the need for treatments that can be administered at home. Celltrion explored the development of a subcutaneous formulation of infliximab (Remsima SC) to extend the treatment longevity of infliximab. The patient could receive a rapid response with Remsima IV and maintain the treatment regimen with Remsima SC, which can be self-administered by patients in the comfort of their own homes. Not only could this reduce a patient’s risk of COVID-19 infection by sparing them their regular hospital visits, but it can also provide patients with a more convenient option without changing the molecule of their current medications. —  HoUng Kim, HoUng Kim, Head of The Medical and Marketing Division, Celltrion Healthcare

My biggest question is: will we get greater clarity on interchangeable biosimilar approvals and launches? The provision in the BPCIA that required drugs, such as insulin and growth hormone, to be regulated as biological products back in March of 2020 could be a game changer for employers. Specialty spend grabs a lot of headlines (rightfully so), but the diabetic class is usually at the top of therapeutic class cost reports — with insulins making up the bulk of that spend. Once interchangeable insulins are readily available, payers and patients should greatly benefit from lowered costs. Hopefully, we will see drug pipeline updates of these products seeking that designation soon, as well as other interchangeable biosimilars targeting originators that still control market share despite there being available biosimilar products. — Matthew Harman, PharmD, MPH, Director of Pharmacy, Employers Health

Will employers 1.) demand transparency about product prices and rebates, and 2.) experiment with different benefit designs to engage employees in higher value options by sharing the savings with them?  Both of these strategies could move the market for biosimilar adoption in the commercial space and could provide lessons learned for a slew of other healthcare services. A related question: will we see a proliferation of meaningful value-based contracts that align incentives for highest value and best clinical outcomes? Our efforts, as advisors to large self-insured employers, will be to educate about and push for these purchaser strategies. — Lauren Vela, senior director, Pacific Business Group on Health

In 2014, Canada saw some of the first approvals for biosimilars and the policy dialogue around this new category of drugs has evolved from that point forward. The accepted notion in the country today is that biosimilar are safe and effective and should be used in preferential fashion at least for bio-naive patients. However, 2021 will see the first big test of that new commitment with the arrival of the Humira biosimilars in Q1 2021. Several Humira biosimilars are expected to launch, and the question hanging over the private insurance market is whether insurers will follow the route taken with Remicade originator deals in 2014/15, or whether the newfound commitment to biosimilars will indeed translate into preferential listing for Humira biosimilars. Some of this will likely depend on the extent of discounts offered and the balance of those discounts with the commitment to a biosimilar strategy that is consistent with the policies established by the provincial governments. — Ned Pojskic, leader, pharmacy & health provider relations, Green Shield Canada