From The Editor | January 20, 2021

Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?

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

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The Biosimilar Development Editorial Board is back for this final installment of its four-part 2021 Outlook Series. Here are parts one, two, and three for those of you looking to catch-up on biosimilars in 2020 and what these experts are most excited about for the year(s) ahead. As the Editorial Board explores which challenges are ahead for 2021, it’s reassuring to note that sustainability is increasingly entering the U.S. biosimilars conversation. As you’ll note in this installment, there are several particularly passionate calls-to-action for companies to confront misinformation, collaborate with stakeholders, and to refine their commercial business models in the name of greater market efficiency. Though there is a lot to be done, it’s clear from these answers that stakeholders are relying more heavily on biosimilars and that it’s more important than ever for biosimilar companies to keep carrying the torch for more competition, cost-savings, value, and responsible pricing.  


Anna Rose Welch: What will be the single biggest challenge biosimilar companies or biosimilar stakeholders will run into in 2021? Which specific strategy(ies) should the industry OR critical stakeholders use to address this challenge?


The biggest challenge is gaining market share, and that should occur with even small reductions in price. However, avoiding crash-to-the-bottom-pricing is also very important. So, I would like to see sustainability become more of a consideration as we continue to seek appropriate competition and adoption. — Gillian Woollett, SVP, Avalere Health


The U.S. has failed to harness the savings promised by a robust biosimilar market.  Unfortunately, barriers such as regulatory hurdles, payer disincentives, market dynamics, and misinformation campaigns have held the biosimilars market back. Biosimilars continue to be an essential component of healthcare systems, both in terms of expanding access to biologic therapies, providing patient and physician choice, and addressing healthcare budgets. At Viatris, we will be working to provide evidence-based information to inform and support public policies that encourage the three A’s – Awareness, Access, and Adoption of biosimilars.

The value brought by biosimilar competition is imperative as health system resources are constrained by the COVID-19 response. Biosimilars will be a critical component of a post-COVID-19 health system as economies increasingly feel the aftershocks of this global pandemic. COVID-19 necessitates the prioritization of international collaboration to implement policies streamlining biosimilar development and approval. Further, the pandemic highlights the need for urgency in putting into action payment policy incentives to advance the uptake and acceptance of lower cost biosimilar medicines. — Tiffany Fletcher, Head of Global Biosimilar Policy & Access, International Affairs & Global Policy, Viatris


The biggest challenge is for biosimilar companies to maintain a rigorous risk-adjusted business case for their biosimilar endeavors. We’ve conquered some challenges, and we are making headway on many others, but some significant challenges still remain. Is the business case still strong enough to support our continued investment? The U.S. healthcare system needs us to answer with a resounding “yes.” We have to figure out how to make that happen. A comprehensive solution with results today and a foundation for the long-haul is what’s needed.  Let’s continue to improve our commercialization infrastructure and tactics; let’s continue to address the great obstacles of IP games and product hopping; and let’s look for ways we can work together for the good of the industry so that we’re not going it alone unnecessarily. — Edric Engert, Managing Director, Abraxeolus Consulting 


Mixed payer coverage continues to create challenges for the biosimilar market. If biosimilars are given equal treatment as biologics in terms of payer coverage, it will likely lead to faster overall adoption, foster competition, and alleviate drug costs across biosimilars and biologics.

Payers can remove barriers for providers as they make clinical decisions with their patients by providing equal coverage and reimbursement for biosimilars. Providers want to and should be able to make these clinical decisions in the best interest of their patients without being restricted by a payor requirement or mandate. We must embrace biosimilars and patient choice as the resulting competition increases access to both biosimilars and biologics for 1.2 million patients and savings that could potentially exceed $100 billion by 2025. We’ve seen and expect payers to continue to evolve and expand their coverage of biosimilars. We hope to see more payers move in this direction to cover more biosimilars in 2021. — Sean McGowan, Senior Director Biosimilars, AmerisourceBergen


Despite progress this year, disparagement and misinformation continues to be a challenge to biosimilar adoption, including direct efforts to foster fear through targeted misinformation campaigns. As we look to a future with increasing biosimilar availability, it is critical that we advance policies and initiatives to further educate patients and providers on the safety and efficacy of these treatments.

As part of the FDA’s Biosimilars Action Plan, the agency has committed to develop effective communications to improve understanding of biosimilars among patients, clinicians, and payers. We are encouraged by this, as well as actions from the Federal Trade Commission, to combat pervasive misinformation. Ultimately, all stakeholders need to do their part to stop misinformation campaigns aimed at maintaining the status quo of using more expensive originator biologic medicines. This is an important step forward to encourage biosimilar uptake and to realize the full potential of biosimilars to improve patient access and generate cost savings. — Hillel Cohen, Executive Director, Scientific Affairs, Sandoz


I’m not certain that final decisions have been made with respect to whether differentiated products will be considered biosimilar versions of an innovator product or novel derivatives of an innovator product with patent exclusivity. AbbVie has introduced a citrate-free version of Humira, and less pain upon injection is a bona fide advantage for patients. There are five or six approved adalimumab biosimilars awaiting launches in 2023, but the market opportunity for those drugs will undoubtedly be smaller than their developers envisioned.  Similar methods of differentiation have been created by Roche, with Subcutaneous (SC) Herceptin and SC Rituxan. While no one can question the convenience of a SC injection vs. an IV infusion, it’s also likely the market availability for the companies who have developed and are developing the traditional biosimilar versions will be dramatically smaller. The E.U. has determined some products like these are categorized as biosimilars, whereas it appears the U.S. will determine they are novel.  I’m not sure the concern for this divergence of views would rise to the level of “single biggest challenge” for 2021, but the potential for market opportunity reductions for biosimilar developers could be significant. In recent years, only the very large brand and generic companies have been able to penetrate the biosimilars space due to the enormous costs of complex development and manufacturing. If these markets continue to shrink as a result of differentiation in innovator products, the smaller companies might not be able to participate. — Ross Day, Consulting Hospital Pharmacist, Former Director of Pharmacy, Vizient


The biggest challenge that has come to light — particularly after last year’s launches in the oncology space — will be keeping a decent commercial margin following deep cuts in reference product pricing and in markets where there are five or more biosimilar products competing against each other. — Francois-Xavier Frapaise, ClinExcel


2020 has been an unprecedented year as the world grappled with the devastating impacts of COVID-19. Due to the COVID-19 pandemic, there will be an increasing burden on the healthcare system to finance budgets and find savings to ease some of that burden for patients, payers, and providers. We believe there will be a room to drive down the overall cost of existing medicines through wider adoption of biosimilars.

As biosimilar manufacturers expand their pipeline in the increasingly competitive biosimilar space, opportunities still exist for biosimilar manufacturers to increase the value that biosimilars bring to the healthcare system outside of lower prices. In the long term, we hope that some of the innovations we apply to biosimilars to promote a better patient experience will also encourage a more sustainable model for biosimilars and bioinnovatives (value-added medicines) as Celltrion has done with its subcutaneous formulation of Remsima. — HoUng Kim, Head of The Medical and Marketing Division, Celltrion Healthcare


This year is the 10th anniversary of the BPCIA, which established the first regulatory pathway for biosimilar medicines in the U.S. Despite the progress this legislation has delivered — including enhanced patient access to high-quality biosimilars and greater competition in the biologics market — we must ensure that the pathway remains in place and that policy changes support access and adoption of biosimilars.

To fully realize the promise of biosimilars for patients and overburdened healthcare systems, the pathway for biosimilars must be finalized and maintained, and policies must be implemented to ensure that biosimilars can be used by patients. By enacting commonsense policies, we can continue to increase the number of available biosimilars on the U.S. market, thereby enhancing patient access to biologic medicines and generating significant savings for healthcare systems. — Brian Lehman, MBA, MHA, RPh., Director, Strategic Alliances & Patient Advocacy, Sandoz


Intellectual property (IP) barriers have proven to be one of the biggest challenges for commercializing biosimilars, especially in the U.S. The Federal Circuit’s 2020 decision to reject Sandoz’s attempt to bring to market its Erelzi (etanercept) biosimilar was viewed with disappointment by biosimilar developers, particularly after a similar outcome in the preceding years regarding Humira (adalimumab) biosimilars. However, optimism stems from the fact that not all biosimilar molecules incur the delays experienced by etanercept and adalimumab products. For example, the successful launch of bevacizumab biosimilars in the U.S. over a year prior to their launch in Europe demonstrates that not all originator companies establish IP barriers that effectively delay biosimilar entry in the U.S. compared to the rest of the world. — Noelle Sunstrom, CEO, NeuClone


While the biggest challenge for biosimilars is removing the barriers to access and uptake through proactive stakeholder policies, there is a second issue that is just as important and requires addressing. The second biggest challenge is addressing misinformation regarding the success of the marketplace and advancing the position that biosimilars do not require any new policies to support their uptake. Unfortunately, those who advance the misperception of a robust and successful marketplace (at a 20 percent efficiency rate as per the latest IQVIA study), fail to take the view of the stakeholders that matters most: the patient and purchaser.

Simply put, from a patient and purchaser perspective, a 20 percent market efficiency means there is an additional 80 percent in cost savings yet to be achieved in the US. Twenty percent from the perspective of stakeholders who need cost savings should NOT be viewed as a success. 

It’s important for all stakeholders to remind themselves why we worked so hard to pass the BPCIA 10 years ago: to create competition and provide lower cost biosimilars to patients. It’s important that when we talk about the success of the biosimilars market, we continue to view it through the lens of the patients we serve. Are we doing our best for them? Could we as a collective of stakeholders do more to provide cost savings through biosimilars?

The answer is yes; we need to do more to improve the U.S. biosimilars marketplace. All of us, as the biosimilar collective, can do more. I look forward to 2021 when we achieve the promise we made 10 years ago when we fought so hard for BPCIA: cost savings through competition and lower cost biosimilars for the patients we serve. — Julie Reed, Vice President, Corporate Affairs Lead – I & I and Biosimilars, Pfizer


Europe will be launching its EU Beating Cancer Plan in 2021. This plan is an ambitious endeavor to curb the current trends which, if left unchanged, could see cancer become the leading cause of death in the EU. With every year, 3.5 million people in the EU are diagnosed with cancer, and 1.3 million die from it. Over 40 percent of cancer cases are preventable. While the current roadmap does not acknowledge the role of biosimilar medicines, it is essential that biosimilars be integrated into the plan. The growing number of available biologic therapies in cancer is associated with substantial increases in the pharmaceutical budget, which biosimilar competition can help manage. Biosimilar medicines are available in a number of cancer therapies and the cost effectiveness gains can serve the overall Plan by allowing reinvestment of the savings into all four pillars of the strategy: Prevention, Detection/screening, Treatment and Care, as well as Quality of Life. The EU has many examples of benefit-sharing schemes through which reinvestments have led to targeted improvement in healthcare and patient care. Cancer is a more recent area where biosimilar medicines have become available. The promise of effective competition for medicines that have lost or are close to losing market exclusivities clearly point towards significant reinvestment opportunities that are within reach. It is just a matter of aligning the objectives with the existing resources. — Julie Maréchal-Jamil, Director Biosimilars Policy & Science, Medicines for Europe


I am concerned that the slower than anticipated uptake of biosimilars will cause manufacturer shareholders and executive leadership to feel pressured to reduce investments on biosimilar research, production, and litigation. I understand that the lack of biosimilars in the pharmacy benefit side is discouraging, but I cannot stress enough how much employer groups and their consultants will be pushing to promote the products once they are available. We are seeing the shift in utilization towards biosimilars under the medical benefit. The trajectory of specialty spend is unsustainable without lower cost alternatives, so this is my plea to any manufacturer representative reading this that is considering pulling out of the market: Stay engaged. Our patients and budgets need you. — Matthew Harman, PharmD, MPH, Director of Pharmacy, Employers Health


The challenges for biosimilars will continue to be the same as they have been over the past five years. These challenges include continuing to highlight the importance of biosimilar-first strategies and countering misinformation and other anti-biosimilar efforts. The other challenge is related to health care resourcing. With COVID-19 dominating provincial efforts, there are few resources available for other policy initiatives, such as biosimilar switching. As previously mentioned, this scenario is unlikely to change until mass vaccination efforts have been completed and provincial policy making can return to non-pandemic-related aspects. —  Ned Pojskic, Leader, Pharmacy & Health Provider Relations, Green Shield Canada


The future of biosimilars will depend upon state and federal legislation, market dynamics, and the behaviors of competing companies and their negotiations with payers. We need to see increased transparency around various state Medicaid programs and their inclusion of biosimilars on their formulary. We need to advocate for parity with our wholesalers and GPOs, but most importantly the payers. Ultimately, this parity promotes competition and eliminates shortages which could occur if a party places their faith in just one product. It is imperative for biosimilar manufacturers to be mindful of preserving ASP during their contract negotiations, especially with payers. I realize there are instances in which offering steeper discounts than those of the competitors may help gain formulary access or achieve market access more quickly. However, this “race to the bottom” is not sustainable. As a market, we must all remember that the U.S. is still in its biosimilar infancy, and we need biosimilar innovation to help right the ship of our currently unsustainable U.S. healthcare system. — Kathy Oubre, COO, Pontchartrain Cancer Center