AHG Physician Featured: What Does 2020 Hold for Biosimilars? Industry Experts Weigh In
Education, Rheumatology Updates
Thursday, December 26 2019
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) “[m]aximiz[e] scientific and regulatory clarity for the biosimilar product development community”; (3) “[d]evelop 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.