By Anna Rose Welch, Chief Editor, Biosimilar Development
Biosimilar Development is happy to usher in the new year with its third installment of the Editorial Board Q&A series. As you’ll read in the following responses, increased competition in 2021 is on the minds of many. Whether that competition is unlocked thanks to shared savings models, employer biosimilar initiatives, new/multiple product launches, and/or regulatory evolution, we just have to wait and see. But if one thing is clear, it’s that the industry has many exciting tools on the line that are worth watching as 2021 unfolds.
Anna Rose Welch: What is one big market development you anticipate we could see in 2021 that will meaningfully advance the industry? (This could be a new policy, product launch, regulatory decision, etc.)
The biggest market development slated to occur in 2021 is the arrival of Humira biosimilars in the Canadian market and the decisions this arrival will trigger for Canadian payers. The other big development that has yet to materialize is the tangible movement by the largest province, Ontario, towards biosimilar transitioning. In early 2020, that commitment to transitioning was signaled by the provincial government but has taken a back seat to the challenges associated with COVID-19. Ontario is now facing a second surge of COVID cases and the continued planning for the pandemic response will dominate provincial Ministries of Health. It is unlikely that any movement on biosimilar switching will occur in Ontario until mid-2021 (at the earliest) when the pandemic could start to subside with vaccination and other efforts. — Ned Pojskic, VP pharmacy benefits management, Green Shield Canada
Will we see a shared savings model enacted in the Medicare program? If so, the framework and infrastructure would be there for commercial plans to implement, which would be embraced in the employer benefits world. Employers are looking for ways to save specialty dollars for themselves and all the lives they cover. A shared savings model would incentivize prescribers to select the less expensive biosimilars and help achieve those employer goals. My hope is that the Increasing Access to Biosimilars Act will make it through Congress in 2021 to bring that model into the healthcare system. — Matthew Harman, PharmD, MPH, director of pharmacy, Employers Health
At the heart of the biosimilar success story is robust regulatory science. We have seen that inroads have been made over the last two years to translate the 15 years of EU regulatory and clinical experience into advancing regulatory science. We anticipate that the debate over the default requirements for comparative clinical trials as part of biosimilar development will progress. This is a topic where global regulatory dialogue and action plans should take center stage beyond the EU. This is the most pragmatic and meaningful way to achieve greater availability of biosimilars and broader geographic reach.
This scientific success will only benefit patients and the healthcare community. There needs to be a greater understanding of the underlying scientific principles involved in biosimilar development, as well as the biologic medicines life cycle in general. This will further emphasize that the streamlining of the biosimilar clinical trial requirement is a logical evolution of the biosimilar paradigm rather than a revolution. — Julie Maréchal-Jamil, director biosimilars policy & science, Medicines for Europe
I anticipate we’ll see the support and finalization of new policies by Congress and the Biden Administration which remove the barriers that are limiting access and uptake of biosimilars. It’s time to support this new marketplace and realize the cost savings biosimilars will bring to healthcare. — Juliana M. Reed, VP, corporate affairs lead – I & I and biosimilars, Pfizer
I’m closely watching the maturation of a highly competitive U.S. oncology biosimilar market. Having first launched in the U.S. in 2019, multiple biosimilars referencing trastuzumab, bevacizumab, rituximab, and pegfilgrastim now compete with these reference products. Following positive early uptake during 2019-2020, 2021 may be the year in which at least some of these refence products lose their respective majority market share to biosimilar competitors. — Noelle Sunstrom, CEO, NeuClone
I’m encouraged by the recognition biosimilars are gaining among state employers, retirement systems, and self-insured employers looking to reduce their costs and those of their employees. This has substantial implications for the industry going forward, as these stakeholders are becoming more aware of the low mid-single digit use of and missed opportunities for savings from biosimilars. Additionally, these stakeholders are recognizing new tools to provide enhanced coverage for biosimilars that can lead to significantly larger healthcare savings along with increasing access.
Earlier this year, The ERISA Industry Committee released a study that suggested all self-insured U.S. employers could have saved $1.4 billion on two biologics in 2018 if they expanded use of biosimilars. Moreover, their employees would have saved on average $300 and $600 in out of pocket costs for two different biosimilars. As the benefits of biosimilars become more widely known, we expect to see a greater push from these stakeholders on health plans to increase their support of biosimilars. — Brian Lehman, MBA, MHA, RPh., director, strategic alliances & patient advocacy, Sandoz
In 2021, we expect there will be new biosimilar launches and existing biosimilars taking more market share from the reference product, resulting in increased market competition. In particular, competition will be very dynamic with the arrival of Celltrion’s Humira biosimilar in the market as well. Product differentiation has been an important way Celltrion has chosen to gain an edge in the marketplace, and the high concentration formulation of CT-P17 is an example. Celltrion’s CT-P17 will be the world’s first highly concentrated and citrate-free type of medicine for a biosimilar made of adalimumab. CT-P17 could also be a more convenient option for patients by potentially reducing the injection volume. Celltrion plans to optimize method of administration and regimen by offering various strengths. We anticipate launching CT-P17 in the EU market once authorization is granted from the EMA this year. In terms of portfolio strategy, CT-P17 can be used as sequential treatment with Remsima (CT-P13) SC so that patients can use a drug to achieve long-term drug survival. Considering the COVID-19 impacts, we believe the subcutaneous injector market is likely to experience a tremendous growth in the near future. — HoUng Kim, head of the medical and marketing division, Celltrion Healthcare
Increased pressure on drug budgets following the COVID-19 crisis could help biosimilar adoption overall in 2021. I also expect regulators could become more receptive of registrations with more limited patient numbers/large-scale clinical studies. — Francois-Xavier Frapaise, M.D., ClinExcel
A biosimilar Shared Savings model may be on the horizon for 2021. This can be achieved in a variety of ways. Such a model could be arranged between employers and their health plan. Similarly, individual medical practices may include this into a larger value-based care model with their payers or through CMMI. A Biosimilar Shared Savings model could achieve cost savings without reducing services or quality of patient care. Given the low costs for startup and ongoing monitoring, and lack of physician downside risk, we could see high provider participation and high payer interest. Additional support would likely include biosimilar manufacturers and patient advocacy organizations. — Kathy Oubre, COO, Pontchartrain Cancer Center
I’m anticipating the tailwinds that have in recent years helped the fledgling biosimilar industry gain sustainability in the U.S. will be bolstered by a new sense of bipartisan cooperation. Such bipartisanship might be expected in areas such as:
- Passage of the ACCESS for Biosimilars Act which would eliminate the 20 percent cost share imposed on patients using Medicare Part B coverage for biosimilars. Most current biosimilars are infused medications covered under the Medical Benefit and reimbursed based on an ASP calculation. This often leaves patients responsible for a significant portion of a high cost drug, and, therefore, frequently not able to use that drug.
- Other bills are focused on the actual reimbursement formulas, with some proposing to change reimbursement to ASP +8 percent from the current ASP + 6 percent methodology. This should further incentivize providers to use the biosimilar alternative.
- More from the FDA; The BAP was definitely not the blockbuster engine designed to foster biosimilar adoption as it was hyped to be. More is needed, including:
- A supportive leader of the agency with strong feelings about the merits of biosimilars, much like former commissioner Dr. Gottlieb who was described as a “champion” for biosimilars
- A substantial educational initiative for patients and providers regarding the merits of biosimilar adoption.
- More guidance and interchangeability clarity, Purple Book reform, and nomenclature reform — Ross Day, consulting hospital pharmacist, former director of pharmacy, Vizient
There is a growing appreciation that Phase 3-style safety and efficacy studies do not contribute meaningfully to the totality of evidence in support of biosimilar development. The UK health authority has recently suggested that biosimilar clinical development can be tailored based on current science so that efficacy studies would be required only if there were unresolved uncertainties after comparative analytical, PK, and immunogenicity studies. The FDA has recently announced that they are investigating use of biomarkers in clinical studies in place of classical efficacy or safety endpoints. Acceptance of the concept of tailored biosimilar clinical development has potential to accelerate future biosimilar development which would allow patients to access the benefits of these therapies more quickly. — Hillel Cohen, executive director, scientific affairs, Sandoz
Expanding the biosimilar market to include insulins was one of the biggest market developments in 2020. This move will undoubtedly create more patient access and increase competition and cost savings for patients at the pharmacy counter. It will be interesting to see how an increase in competition impacts the already large insulin market upon which millions of patients rely.
To date we’ve seen biosimilars launch between a 10 percent-57 percent discount compared to their originator products (WAC price). Bringing competition to such a significant market will likely produce similar cost savings and expanded access to patients who rely on insulin. Additionally, if biosimilar insulins are automatically granted interchangeability, we expect insulin biosimilars to be priced competitively. In other words, this would deliver cost savings directly to patients and hopefully have a positive impact on their copay and coinsurance costs.
In the meantime, we will keep an eye on Mylan and Biocon Biologics’ Semglee. Semglee was deemed a biologic under section 351(a) per the BPCIA earlier this year. Mylan has submitted all necessary documentation to request approval of Semglee as a biosimilar to Lantus under the 351(k) pathway. The FDA is slated to make a formal decision in 2021. The potential approval of Semglee coupled with the passing of HR8190 could be the first step to increasing competition and cost savings in the insulin market. — Sean McGowan, senior director, biosimilars,
In terms of legal developments that may have effects on the market, the outcome of antitrust claims against reference product sponsors will continue to impact expectations in terms of biosimilar market uptake. This year an Illinois district court found that AbbVie’s so-called “patent thicket” on its blockbuster Humira did not violate the antitrust laws. That decision has been appealed to the Seventh Circuit, and further activity is expected in the new year. We’ve also been watching litigation about Johnson & Johnson’s contracting practices related to Remicade, which are alleged to have forestalled competition from biosimilar infliximab products. In May, the parties agreed to an indefinite stay of all deadlines due to COVID-19, and a new scheduling order has not yet been set; as a result, timing of trial and decision on the merits remains uncertain. The ultimate outcome of these cases could have an effect on both the speed with which biosimilars can get to market and how quickly biosimilars can gain market share following launch. — Alexandra Valenti, partner, Goodwin Procter LLP
I’m incredibly interested to see what may happen under the new Administration and what executive actions could be taken that are best for the U.S. healthcare system. Therefore, I will be watching the policy and government affairs area closely, along with how the industry and AAM under its strong new leadership will react. — Edric Engert, managing director, Abraxeolus Consulting
We do expect the first interchangeable biologic to be approved by FDA. How that type of product is received and priced, with what market share, and how quickly that is achieved is going to be extremely interesting to watch. — Gillian Woollett, VP, Avalere Health
Misaligned incentives and the complicated benefit structure within the Medicare prescription drug program have disadvantaged follow-on medications (generics). Current trends in formulary placement of these medications have resulted in lost savings to patients despite their lower price. This trend has the potential to threaten future savings to patients promised by biosimilar competition. FDA approvals do not equate to patient access, and there remains much work to be done in 2021 to clear existing market barriers to ensure that FDA-approved biosimilars are given preferred access or, worst case, equal access to reach patients and have sustainable commercial success.
In 2021, the U.S. anticipates the introduction of biosimilar competition in the retail pharmacy setting. This coincides with continued bi-partisan support to lower patient out-of-pocket costs for prescription drugs and recent political efforts to make structural changes throughout the Medicare program. Prioritizing access to biosimilars on Medicare prescription benefit formularies will help ensure seniors receive the savings attributed to these safe and effective medicines. — Tiffany Fletcher, head of global biosimilar policy & access, international affairs & global policy, Viatris