By Anna Rose Welch, Editorial & Community Director, Advancing RNA
We’re all familiar with the famous quote from The Beatles, “I get by with a little help from my friends.” This statement rings true for my experiences with this publication, as well. This publication would not be what it is if it wasn’t for the experts who have generously agreed to take part in the Biosimilar Development editorial board. So, in an effort to show off their magnificent brains as we approach another year of biosimilar magic and mischief, I sent them a few questions about their reactions to the last year and what they’re watching moving into 2019. In the first part of a three-part “Ask The Board” series, members of the editorial board share what left them feeling the most heartened or concerned in 2018 and what must take center stage as we head into 2019.
Throughout 2018, how have your expectations or thoughts about the biosimilar industry evolved, either positively or negatively? Was there a specific market development that led to this change in your expectations for the better or the worse? Please explain.
2018 was another year during which we saw steady but important growth in the penetration of biosimilars in the Canadian marketplace. This was in large part driven by the continuing support of the public drug plans across the country which reaffirmed their position of strong support for a thriving biosimilar market. In particular, the Pan Canadian Pharmaceutical Alliance (PCPA) issued renewed principles on biosimilars which stated that biosimilars will continue to play an important role in driving sustainability of drug plans.
—Ned Pojskic, Leader, Pharmacy & Health Provider Relations, Green Shield Canada
I am quite encouraged by the FDA’s efforts to increase the awareness of biosimilar products among prescribers and consumers. A good way to track this progress is by checking out the biosimilars section on the FDA website, which has significantly expanded throughout 2018. Compared to even just 12 months ago, there is now plenty of useful, easy-to-understand educational information, including a video featuring Commissioner Scott Gottlieb explaining “the Promise of Biosimilars.” This renewed dedication to biosimilar products from the very top appears to be permeating throughout the agency and helping to foster a more collaborative relationship with the biosimilar industry.
—Hubert C. Chen, MD, medical and scientific advisor, Pfenex
The last year was another significant period for biosimilar approvals and launches. Biosimilars of Humira, Herceptin, and Neulasta are now changing the European healthcare systems, leading to significant cost reductions and broader patient access. The number of biosimilars entering the market exceeded expectations. However, price erosion has become an increasing risk. We have seen substantial discounts with adalimumab biosimilars in a very early phase of commercialization, and discussions have been started on substitution at the pharmacy level in Germany. Drastic price erosion impacts the long-term sustainability of the biosimilars market as it could result in decreased competition. So, a balance is needed which considers both patient access and the sustainability of future markets.
—Ruediger Jankowsky, managing director, Cinfa Biotech
Over the course of 2018 there have been both positive and negative developments which have impacted the biosimilar market. On the positive front, the FDA is now strongly promoting innovation, efficiency and competition through the Biosimilar Action Plan. A comprehensive literature review was published, as well as other additional switching studies, supporting statements that there is no impact on safety or efficacy when transitioning from a reference medicine to biosimilars. This review and the underlying studies are of vital importance to further increase provider, payer, and patient confidence in switching. Employer groups are growing their efforts to help drive appropriate promotion, adoption, and utilization of biosimilars. They are getting more involved with activities such as identifying opportunities where vendors’ fill rate for biosimilars is low relative to the reference medicine, collaborating with vendors to find solutions, educating employees on biosimilars, and programming advocacy initiatives.
However, despite the available science, transitioning from a reference medicine to its biosimilar or biosimilars is facing opposition and misinformation. Patient and provider confidence is being influenced by false or misleading information about the safety or efficacy of biosimilars in all labeled indications. This includes extrapolated indications, as well as inferences that the quality of a medicine that is “only” a biosimilar is not as effective as an interchangeable biologic. This is occurring at a time when awareness, perceptions, and knowledge gaps still exist for these stakeholders. This threatens the expansion of biosimilar treatment options, potential improvement of patient outcomes by increasing access to therapies and supporting medication adherence by providing a clinically equivalent option at a potentially lower cost. As such, the promise of biosimilars is only slowly coming to fruition because of current barriers.
—Brian Lehman, MBA, MHA, RPh., director, medical account management and strategic alliances, Sandoz
There have been significant improvements in regulatory, clinical, and commercial aspects in the biosimilar space this year, as the healthcare industry embraced the potential benefits biosimilars can bring to meeting patient needs. For instance, in the U.K., the NHS saved £324m in the last financial year by switching patients to better value biosimilars.1
Although the United States lags Europe in availability of biosimilars, the U.S. biosimilar market has the potential to be the largest in the world.2 The American Society of Clinical Oncology (ASCO) have issued statements this year affirming commitment to enhancing confidence in biosimilars that ensure efficient approval, unrestricted access, and appropriate use of biosimilars.3
Despite reported interest from stakeholders, biosimilars have had limited uptake so far; more work needs to be done to tear down market barriers to biosimilars, and it will require cooperation from a robust coalition of stakeholders.
—HoUng Kim, head of strategy and operations, Celltrion
My expectations have evolved in both positive and negative ways. On paper, in the EU, it looks like we are in an “OK” place today: biosimilars are used in every country; most medical societies and patient organizations recognize the access benefits brought to date with over 12 years of biosimilar use.
2018 has definitely been very, very busy on the biosimilar medicines front. In the EU, we’ve had multiple new authorizations and launches, including the much anticipated and analyzed Humira patent expiry and simultaneous biosimilar version launches. That is the macro perspective, and of course, it is all quite positive.
However, it feels that, in terms of policies, we tend to still see silos — narrow reflections on 1.) tackling health inequalities, 2.) managing health budgets, and 3.) fostering the appropriate conditions for biosimilar medicines use. Cumulatively, there is an obvious and central question for policy makers still to answer: how can one justify not using biosimilar medicines where they exist?
Limited adjustments and considerations in the currently existing frameworks across the EU could support optimal use of biosimilar medicines and foster ready re-investment in health. Why isn’t the easiest step being taken?
—Julie Maréchal-Jamil, director, biosimilars policy & science, Medicines for Europe
There have been several major developments in 2018 that are worthy of mention. To date, the U.S. Food and Drug Administration (FDA) has approved six biosimilars in 2018 and many more seem to be moving closer to approval. At the same time, five other biosimilars that were approved in Europe received Complete Response Letters from FDA. Taken together, this clearly demonstrates that the FDA is gaining experience with biosimilars and is moving forward rapidly while, at the same time, revealing that each health authority may differ in their interpretation of data.
In the broader venue of healthcare professionals and patient knowledge, the FDA has increased educational efforts of key stakeholders, initially focusing on physicians and more recently on other stakeholders such as pharmacists and patients. We would also welcome FDA outreach to health plans and other payers as they are an integral part to patient access. The current leadership of FDA and HHS has spoken out forcefully in support of biosimilars. All of these are welcome developments and will help pave the way for broader acceptance of biosimilars in the U.S. However, the game of whack-a-mole continues. Misinformation and dissemination of incomplete information regarding biosimilars continues to be distributed and needs to be addressed.
Finally, it is important to point out the fact that getting a medicine approved is clearly not sufficient. Our focus needs to be on getting these medicines to patients.
—Hillel Cohen, executive director, scientific affairs, Sandoz
Overall, 2018 has been a very positive year in the biosimilars space with lots of innovation both from a product and process perspective. In 2018, we saw greater alignment between the current presidential administration and the FDA, both acknowledging biosimilars as a solution to bring innovation to the market while maintaining cost-effectiveness. For example, as part of the blueprint for lowering drug prices, the administration and FDA are working on addressing what is called the “rebate trap” – a fear that wider adoption of biosimilars will eliminate manufacturer rebates and raise costs for payers, rather than lower them. This includes looking more seriously at the interchangeability between biosimilars and their reference products, as is possible with small molecule drugs. Further, the FDA is introducing policies in favor of biosimilar affordability, and it recently announced changes to the purple book, which gives guidance for how biosimilars are brought to market.
Nevertheless, it’s taken more time than expected for these regulations to be established, and it will be longer still before we experience their full impact. In 2019, we hope to see momentum continue to build for biosimilars, with further alignment of stakeholder incentives and the ability to select biosimilars as treatment options. We hope the U.S. market can continue to evolve in the direction of the European biosimilar market and more and more obstacles to biosimilar development are reduced (e.g., patent challenges and litigation).
—Rick Lozano, VP, biosimilars and integrated business development, AmerisourceBergen
The biosimilar industry is evolving well in Europe and a number of nations are being quite active in trying to promote the uptake of biosimilars. This is certainly a positive development as long as health authorities realize that biosimilars are not like generic small molecule medicines and that patients cannot be switched back and forth between the different biosimilars. Each biosimilar for the auto-immune diseases will have a different device for administration of the product and the patient, nurse, and clinician will all require training on the different devices.
The U.S. market on the other hand is developing more slowly than hoped with market shares of the recently launched auto-immune products struggling. The FDA has issued many positive statements supporting biosimilar market access, and the rhetoric from the Administration, in general, is looking at different aspects of the market to bring down drug pricing. Of course, the entry of biosimilars onto the U.S. market can certainly assist in this regard.
—Sue Naeyaert, global government affairs, policy, and pharmacoeconomics, biosimilars, Fresenius Kabi
My thoughts have always been that healthy sustainable returns from biosimilars in the U.S. are a matter of “when” and not “if”. There are, however, multiple events that have caused me to wonder if the “when” will continue to be pushed out further rather than reined in.
Firstly, settlements. Given the depth and complexity of patent thickets and the mighty returns that originator companies enjoy, it’s no wonder that biosimilar companies are opting for settlements even while holding a high likelihood of success in their legal positions.
Secondly, commercialization tactics to block biosimilars. The ongoing Pfizer-Janssen case is a clear illustration. And while some may say not to worry — that this is the Gx world after the passing of Hatch-Waxman all over again — I would say it’s similar, but notably more difficult. Branded pharmaceutical firms are much more adept and forwarding-thinking in how to delay the onset of biosimilars. We have seen this not only in their commercialization tactics to block biosimilars, but also in the past when they inserted key provisions into BPCIA making biosimilars as difficult a path as possible.
However, hope should not be lost on this point. In 2003, massive changes were made to Hatch-Waxman as it was clear there was too much gaming of the system. It’s been nearly nine years since BPCIA was passed. It’s time to recognize there is once again gaming of the system and that BPCIA isn’t producing robust competition. Has anyone in the biosimilar industry – company, trade association, or consultant – authored any federal or state legislation to combat the existing barriers and achieve their objectives?
This fundamental question becomes a segue to my third and final fear – that we are not appropriately capitalizing on opportunities for change and improvement. The Administration has made biosimilars and their adoption one of their areas of focus. At a conference last September, two prominent HHS officials even reached out and asked for assistance in making change a reality. What we need to do is move beyond white papers, comments, hearings, and presentations focused on issue identification. Instead we need to engage in real problem-solving and action. I’m not entirely sure we as an industry have fully embraced or begun planning and resourcing this clear need to move beyond issue identification to tangible action.
—Edric Engert, managing director, Abraxeolus Consulting
My expectations about the biosimilar industry have evolved positively. Approvals of additional biosimilars by regulatory agencies, particularly the FDA, support future investment in this sector of the pharmaceutical industry. With Pfizer’s steep discount on Retacrit (57 percent of the price of competitor J&J’s Procrit), we see a new trend emerging that confirms PlantForm’s prediction that the market for biosimilar large molecule drugs will move towards the significant pricing discount structure of small molecule generic drugs (contrary to previous industry projections that biosimilars would be priced at 70-80 percent of the name brand drug). We also see that physicians and decision makers responsible for purchasing drugs are increasingly aware of the efficacy and value of biosimilars, which will fuel increased demand for biosimilar drugs going forward.
—Don Stewart, CEO, PlantForm
Stay tuned for parts 2 and 3 in the upcoming weeks!
1. NHS Improvement UK. The NHS saves £324 million in a year by switching to better value medicines. Published 31 July 2018. Available at https://improvement.nhs.uk/news-alerts/nhs-saves-324-million-year-switching-better-value-medicines/
2. Simoens S, Jacobs I, Popovian R, Isakov L, Shane LG. Assessing the value of biosimilars: a review of the role of budget impact analysis. Pharmacoeconomics. 2017;35(10):1047-1062. doi: 10.1007/s40273-017-0529-x.
3. Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol. 2018;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893