From The Editor | January 15, 2020

Education, Patents, Sustainability, Oh My! Experts Dish On 2020 Biosimilar Challenges

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By Anna Rose Welch, Chief Editor, Biosimilar Development

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In the last few installments, the Biosimilar Development Editorial Board + friends shared the biosimilar triumphs and tribulations of 2019 and their biggest expectations for and questions about 2020. Now, in this final (and, I’d argue, the best installment yet), they provide their thoughts on the greatest difficulties facing biosimilars. There’s obviously still a lot of work to be done. But as discussions around sustainability increase, there is also a growing urgency and passion for seeing this industry succeed — and that passion is not to be underestimated.

What will be the single biggest challenge biosimilar companies or stakeholders will run into in 2020? Which specific strategy(ies) should the industry use to address this challenge?

The single biggest challenge that companies face is convincing stakeholders (i.e., providers, insurance companies, employers, patient groups, policy makers, etc.) that we are at an inflection point of whether the biosimilars market in the U.S. is viewed as a success or a failure. Actions taken by U.S. healthcare stakeholders send signals back to companies as to whether or not it is important to continue investing in the development of biosimilars. Negative signals and new or continuing barriers affect whether we realize the future promise of improved savings for the healthcare system and increased patient access in the U.S.  

By supporting biosimilars, each stakeholder has the opportunity to be part of the solution in offering patients high-quality care at a more affordable price and creating a more sustainable system for patients now and for the future.

  • Brian Lehman, MBA, MHA, RPh., Director, Medical Account Management and Strategic Alliances, Sandoz
     

The single biggest challenge facing biosimilar companies in 2020 is simply confronting the sheer number of hurdles still present. Every stage of the process — from development to patent/exclusivity barriers to marketing to reimbursement — contains landmines. The longer these barriers persist, the more entrenched some issues (such as reimbursement and safety concerns) will become. In short, action on numerous fronts is needed for biosimilars to enter the market and offer savings for U.S. consumers.

  • Michael Carrier, Distinguished Professor, Rutgers Law School
     

I worry that due to the influx of biosimilar competition, prices of reference products will temporarily drop and therefore the price differential might not be substantial enough to warrant change. This might lead to the need for biosimilars manufacturers to engage in the same harmful practices traditionally used for drugs to gain access (i.e., paying off intermediaries). This will result in more competition in the marketplace, which is good, but will not solve the underlying problem of misaligned incentives among the intermediaries and will not bring down prices for employers and patients; exposed to higher list prices. I understand that the only parties truly able to address that would be the ultimate payers of all things in healthcare: CMS and employer sponsors of insurance plans. So, I urge those two large purchaser sectors to please be diligent about appropriate and accountable vendor management to assure that biosimilars get used.

  • Lauren Vela, Senior Director, Pacific Business Group on Health
     

I think the biggest challenge the biosimilar industry faces in the Canadian market is how to ensure that the rational, evidence-based biosimilar transitioning policy implemented by the governments of British Columbia and Alberta gets spread to more Canadian jurisdictions. As previously noted, there are concerted efforts underway to segregate this policy and ensure it remains a BC-only phenomenon. Part of those efforts have been to discredit the BC government’s decision as “radical” and in line with previous BC policy directions around therapeutic substitution which were never adopted in other Canadian jurisdictions. Yet, even as it related to therapeutic substitution, several policy reviews in the 1990’s have shown it to be influential for cost saving without any adverse impacts on patient health outcomes. It is essential that biosimilar transitioning becomes more established across the country in uniform fashion, and lots more work will need to be done to ensure that.

  • Ned Pojskic Leader, Pharmacy & Health Provider Relations, Green Shield Canada
     

As is often the case, the biggest challenge will come from within: How do we move from continued issue identification to tenable solutions that are then brought to action? Combatting misinformation, originators’ commercial tactics to block the adoption of biosimilars, and the IP/Legal system are all at the heart of the problem. But what is each of us doing to address these three things effectively? Individually and in concert with one another?  How are we ensuring that our efforts in combatting these things focus on action and becomes a core part of our daily business and priorities? These efforts cannot be left to just those that work in the policy, government affairs, and legal functions, but must also be addressed by those with commercial and even profit and loss (P&L) responsibility.   

  • Edric Engert, Managing Director, Abraxeolus Consulting
     

There needs to be ongoing education of patients/patient organizations, nurses, physicians, pharmacists, employers on what biosimilars really are. These efforts need to communicate more effectively on the concept that, without wide biosimilars adoption, there is no way public health systems can afford reimbursing emerging new technologies (i.e., CAR-T, checkpoint inhibitors, gene therapy).

I also hope to see companies embracing further research on analytical methods to characterize bioproteins and to gain a better understanding of the structure-function relationship — especially as it relates to the greater definition of Critical Quality Attributes.

  • Francois-Xavier Frapaise, M.D., ClinExcel
     

In the EU, if we want to address sustainability in health systems, we need policies that support the use of biosimilar medicines and factor in mid and long-term perspectives. EU Member States will have to speak more to each other to learn from each others’ experience and good practices. For late adopters, a shift from theory into practice will be required. At this moment, those countries experiencing the biggest health economic constraints are also those with the lowest biosimilar medicines use. This is counterintuitive. At the same time, the question of a sustainable competition environment is one that cannot be left unaddressed. It has become clear for a broad range of stakeholders that fitter-for-purpose procurement practices would benefit healthcare systems in the long run, for example, and that some existing practices focused solely on price reduction were not contributing to long term sustainability.

  • Julie Maréchal-Jamil, Director Biosimilars Policy & Science, Medicines for Europe
     

Biosimilar companies will need to continue to educate and dispel misinformation and myths about biosimilars in order to drive patient and physician confidence in these products. We assume the FDA will also continue to engage stakeholders and develop additional educational materials, as this will be critical to further drive confidence.

  • Molly Burich, Head of Public Policy: Biosimilars and Reimbursement, Boehringer Ingelheim
     

There will be a certain limitation for price competition as more and more biosimilar products enter the market in the coming years. To avoid such price erosions, biosimilar companies should not just settle as a biosimilar, but should differentiate themselves from other players by providing a competitive edge to their products.

There should be cost competitiveness by improving efficiency and innovation in terms of market transition or market development. In this sense, Celltrion is focused on its differentiation strategy for each individual biosimilar product and, as part of this, we are planning several value-added features that are visible to our stakeholders.

These innovative products and so-called value-added medicines will further assist in cost-saving for healthcare systems.

  • HoUng Kim, Head of The Medical and Marketing Division, Celltrion Healthcare
     

While there are many companies pursuing biosimilars, some companies have discontinued efforts to develop some or all of their biosimilar portfolios. No doubt that some companies have discontinued these efforts because the development programs failed, or perhaps they lack the funding, or market conditions have changed. Regardless of the reason, there are certainly some companies that are now questioning the return on investment for biosimilars given the difficulty in getting many approved biosimilars to the market or in capturing a reasonable market share. We need to have a sustainable business model or investment in biosimilars will wither.

One strategy to overcome these concerns would be to streamline biosimilar development based on experience gained to date. There already have been discussions by prominent health authority staff[1] and leading scientists[2] that it may not be necessary to routinely require a phase-3 style clinical confirmation comparison study with safety and efficacy endpoints when we can often gather definitive data from comparative PK/PD studies that also collect immunogenicity data. The elimination of clinical bridging studies of U.S. and ex-U.S. reference medicines should also be possible under certain conditions. These steps will simplify and globalize biosimilar development and will encourage continued investment in biosimilars.

  • Hillel Cohen, Executive Director, Scientific Affairs, Sandoz
     

I suspect we’ll continue to see blockades erected by companies to protect bio-originators with established market share. The ability to offer discounts and rebates as well as to threaten price increases for other medications have proven to be effective ways manufacturers keep biosimilars off formularies.

  • Colin C. Edgerton, MD FACP FACR, Executive Chairman, American Rheumatology Network
     

Until policies for regulations change, patent litigations will continue to cause challenges for biosimilar manufacturers. These patent challenges create major distractions for the biosimilar platform and advocates who support it. Patent thickets can delay biosimilar manufacturers from moving forward with critical steps to support the eventual uptake of their products. For example, manufacturers undergoing litigation will have to hold off on negotiating with major payers for coverage and getting ahead of exclusionary formulary decisions.

2020 is the first year that multiple manufacturers will be launching biosimilars into competitive markets. Therefore, it’s incredibly important that these manufacturers start thinking through a launch strategy ahead of time to ensure they capture market share. Pre-launch, manufacturers will want to educate thoroughly all major stakeholders – payers, providers, health systems, etc. – on the safety and efficacy of their products. Wholesaler partners can help with this effort by working with their own customers to establish greater lines of communication between manufacturers and sites of care.

  • Rick Lozano, VP, Biosimilars & Integrated Business Development, AmerisourceBergen
     

In March, it’ll have been 10 years since the BPCIA was signed into law. It’s a nice anniversary, and it would be great to have something momentous to celebrate in terms of the success of biosimilars in the U.S. Biosimilar companies have been developing biosimilars for many years now with little return, and perhaps one of the biggest challenges for companies is to stay in the game and remain for the long run. There has been some consolidation in the industry, and this will likely continue for some of the smaller players. Otherwise, companies need to spread the net and look to other markets and hang in there because the landscape will change in the U.S.

  • Sue Naeyaert, Consultant, Former Global Government Affairs, Policy, and Pharmacoeconomics, Biosimilars, Fresenius Kabi
     

From a patent perspective, patent thickets will continue to pose a significant challenge to biosimilar applicants. Vast patent portfolios covering reference biologic products make it that much more difficult for biosimilar manufacturers to plan a patent strategy in advance of litigation. Once filed, these more complex cases involving a large number of patents take longer to litigate, potentially delaying judgments on infringement and validity issues that could further delay biosimilar launches. Patent issues should be considered early in the development process to inform which molecules a company should pursue developing in the first place, evaluate the potential for design-arounds, and consider strategies to invalidate certain patents, such as with an inter partes or post-grant review at the Patent Office. Even using all these strategies may not clear the full patent thicket in a given case, which is one reason that patent litigation settlements have been so frequent in BPCIA litigation in the U.S.

  • Alexandra Valenti, Partner, Goodwin Procter LLP
     

The single biggest challenge for the biosimilars industry globally is how to move stakeholders beyond short-termism. There is a universal imperative to build sustainable markets for biosimilars that will continue stimulating competition in 10 years, 20 years, and beyond. Biologics make up a growing portion of originator pipelines and regulatory approvals, meaning biosimilar competition will be even more important going forward. Unfortunately, most stakeholders are primarily concerned with leveraging biosimilars for savings today, even if those savings come from the originator and are not concerned with the implications of these policies on future biosimilar competition. The biosimilars industry in 2020 must find new solutions to address this fundamental misalignment and focus stakeholders’ collective attention to building sustainable systems for biologics access today and tomorrow.

  • Erika Satterwhite, Erika Satterwhite, Head of Global Biosimilars Policy, Mylan
     

I would personally aggregate the biggest challenges facing this industry into two categories:

  • Reimbursement fixes required through some legislation
    • ASP is a flawed measure of pricing (excludes 340-B)
    • Eliminate 20 percent co-pay for Medicare Part B biosimilars (reform seems stalled and rebates are difficult to eliminate)
    • Limit claimed patents to no more than 20 (revise BPCIA patent dance)
    • Change ASP+6 percent to ASP+8 percent for a number of years (as a stimulus)
    • Consider different incentives (ASP +6 percent of innovator’s ASP) - provider gets same add-on, regardless of use of biosimilar or reference
  • Educational Initiatives - “Bust the Myths”
    • Focus on physician education as part of the Biosimilar Action Plan
    • More promotion of RWE; make sure through white papers and other published documents that patients and providers are aware of the 700 million-plus patient days of safe biosimilar use to date
    • Reconsider the paradigm of “interchangeability”; (by requiring burdensome requirements for additional switching studies with no evidence of any more risk from the myriad switching studies already conducted, shouldn’t we consider all approved biosimilars to already be “interchangeable?)
  • Ross Day, Consulting Hospital Pharmacist, Former Director of Pharmacy, Vizient
     

Next year is a high stakes year for biopharma, and biologics are marvelous medicines as well as much of the future pipeline for the industry. However, the U.S. market has to show that it offers biosimilars a fair opportunity to compete, which, largely has not happened thus far. “Wait and see” simply won’t do. As more biosimilars are approved it seems that fear from some originators spreads more widely and efforts to misinform healthcare providers and their patients increases. To prevent competition with such disinformation is just plain un-American.

But complaining without solutions is pointless – we need to return the virtuous cycle to health care, and especially to biologics. We have fantastic products from originators being impacted too, and absent biosimilars stimulating competition there is no room in the health care dollar for them either. That the efforts to condemn biosimilars by a few will negatively impact originators prospects too needs to be recognized and repudiated in the simplest terms. Only then can the promise of biotech be restored for all stakeholders.

  • Gillian Woollett, Senior Vice President, Avalere Health
     

The continued opening of the U.S. market to biosimilars will have profound benefits for biosimilars business models and unmet needs of patients globally. Costs of healthcare in the U.S. will decrease and more patients will be served through biosimilars. Commercial success in the U.S. will catalyze continuing investment in global biosimilars portfolios through use of tiered pricing to suit local markets ex-U.S. and provide advantages to the manufacturer of production at global scale. Opening up the complex U.S. commercial market requires close coordination and education across the entire drugs value chain with whatever policy and regulatory carrots and sticks are required to streamline access and create cost efficiencies for the ultimate payor. 

  • Noelle Sunstrom, CEO, NeuClone
     

The biggest challenge is definitely going to remain delayed entry patenting. Outside of hiring better attorneys than the reference product manufacturer, I think it would be beneficial to create more awareness around the issue. While those of us in the industry are informed, the general public could be a significant ally if they knew the rise in specialty costs are the biggest driver in their premium and copay increases. Six of the top 12 selling drugs in the U.S. would not be in that position if biosimilar products could launch once approved.

  • Matthew Harman, PharmD, MPH, Director of Pharmacy, Employers Health
     

[1] Wolff-Holz E, Tlitso K, Vleminckx C and Weise M. Evolution of the EU biosimilar framework. BioDrugs (2019) doi.org/10.1007/s40259-019-00377-y

[2] Webster CJ, Wong AC, Woollett GR. An efficient development paradigm for biosimilars. BioDrugs (2019) doi.org/10.1007/s40259-019-00371-4