Biosimilars Forum Member Spotlight: 5 Questions For Viatris

The Biosimilars Forum is comprised of companies with the most significant U.S. biosimilars development portfolios. Many of our members also do work on a global scale. Today, we’re highlighting Viatris, the Forum’s newest member.

Viatris is a global health care company that was formed through the combination of Mylan and Pfizer’s Upjohn business and has one of the industry’s largest and most diverse global biosimilars franchises focused on the areas of oncology, immunology, diabetes, ophthalmology, and dermatology. Viatris provides access to medicines, advances sustainable operations, develops innovative solutions, and leverages the organization’s expertise to improve patient health. In honor of World Health Day 2021, the Forum spoke with Tiffany Fletcher, Head of Global Biosimilar Policy & Access at Viatris and Vice President of the Biosimilars Forum Board.

Biosimilars Forum: This month, we are commemorating World Health Day, and this year’s theme is “Let’s Build a Fairer, Healthier World for Everyone.” What role can biosimilars play in building this fairer, healthier world?

Fletcher: At Viatris, we see health care not as it is, but as it should be. We believe that biosimilar medicines are a critical solution to achieve patient access to the right treatment at the right time, helping achieve better health for patients and unlocking value for health systems. Biosimilars can fill an urgent, unmet patient need for more affordable alternatives to existing branded biologic therapies. Biosimilar medicines are approved by regulatory authorities as highly similar to the originally approved brand version with no clinically meaningful differences in safety or efficacy. These vital products can help increase access for current and future patients while supporting the sustainability of health care systems.

Biosimilars Forum: Can you share more about Viatris’ work in the biosimilars space, both on a U.S. and global scale?

Fletcher: Viatris is fully committed to biosimilars and we continue to view this as a long-term global franchise. While we are very proud of our track record in bringing biosimilars to U.S. patients, including achieving the first U.S. approvals for biosimilars referencing Neulasta and Herceptin, we also believe that we can do a lot more in this space and better serve patient needs by continuing to break down barriers to access. Viatris’ biosimilar portfolio and pipeline includes several products across multiple therapeutic areas, including oncology, immunology, diabetes and ophthalmology. From a global perspective, Viatris has over 300 approvals for 7 different biosimilar products in over 75 countries around the world.

Biosimilars Forum: What are the barriers to biosimilar usage? Are these barriers unique to U.S. health care and regulatory systems?

Fletcher: What we have learned from our global experience is that there is no ‘silver bullet’ policy to achieve a successful biosimilar market. Every health system will have a different solution, and even within a system there may be different solutions by molecule or channel.

While there is no single solution, there are best practices that can help each health system find the solution(s) that best suits its unique context to unlock the potential of biosimilar medicines for improved patient access and health care sustainability. This includes a supportive tone from the top and goal-setting, multi-stakeholder engagement and buy-in, focus on policy implementation, monitoring mechanisms and a feedback loop to ensure policies are adjusted based on learnings.

The U.S. continues to work towards the full savings and access 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. The U.S. system is complex, and incentives must always align to ensure that the availability of lower-cost options like biosimilars translate into savings for the entire health care system including all stakeholders such as providers, customers and patients.

Biosimilars Forum: Can you share a global example of a time where a successful policy was implemented to increase access to biosimilars?

Fletcher: A shared savings model is a policy that has been tested in several other markets, including in England, with impressive results both for utilization of lower-cost alternatives and improvement in patient care. Southampton General Hospital engaged in a shared savings agreement with the local Care Commissioning Group (CCG) that pays for hospital-based services to allocate a portion of savings resulting from use of biosimilar infliximab back to the hospital. These savings otherwise would have been realized entirely by the CCG. Using these shared savings, the hospital hired a nurse specializing in IBD to better support patients with their biologic treatment. As reported by the Southampton General Hospital IBD clinical team, the presence of a specialist nurse “resulted in significant gains in care quality and costs” ^[1]. This example illustrates the positive impact biosimilars can have for patient access when the right policies are implemented.

Biosimilars Forum: What’s the one thing you think that patients around the world should know regarding the value of biosimilars?

Fletcher: Families have felt the impacts of COVID-19 acutely, and some racial and ethnic minority groups have been disproportionately affected ^[2]. Many families have had to make hard choices about their family’s health needs over the last year. More can be done to support healthy families and improving equitable access to more affordable medicines, including biosimilars, is a critical piece to how we get there.

Biosimilars continue to be an essential component of health care systems, both in terms of expanding access to biologic therapies, providing patient and physician choice, and addressing health care budgets. 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.

^[1] Taylor NS, Bettey M, Wright J, et al “The impact of an inflammatory bowel disease nurse-led biologics service” Frontline Gastroenterology 2016;7:283-288. Web. 20 Nov 2017. http://fg.bmj.com/content/7/4/283

^[2] The Center for Disease Control and Prevention. “Health Equity Considerations and Racial and Ethnic Minority Groups.” February 12, 2021.