Brought to you by Viatris
For diseases like diabetes and certain cancers, biologic medicines have revolutionized care for patients. But the complexities around delivering these medicines to patients have resulted in lengthy timelines and high costs that can burden patients and healthcare systems. Globally, over the last 15 years, biosimilar treatments have emerged to help address those challenges. Biosimilars undergo rigorous testing to demonstrate no clinically meaningful differences exist in safety or efficacy compared to their reference products, which are the original brand-name biologics. These potentially less costly versions of existing biologics are advancing the goal of having a sustainable, robust market that encourages competition and better serves patients. While progress has been made to bring biosimilars to market and increase patient access in some parts of the world, we can and need to do more to expand access to these medicines in the U.S. and globally.
Barriers to biosimilar treatment creation, approval, and access
Many barriers facing physician and patient adoption of biosimilars stem from misinformation about biosimilars and misconceptions of biologic medicines overall. One of the biggest unfounded beliefs is that biosimilars are “different” from reference or originator biologics. Biologics, including biosimilars, are complex products made from living organisms, so a biosimilar medicine is as similar to the reference biologic medicine as batches of the reference biologic are to each other. Biosimilars are held to the same high standards for approval as all biologics. In the U.S., the medicines are approved to meet the U.S. Food and Drug Administration’s (FDA) high standard and manufacturers must establish that there are no clinically meaningful differences in the safety, purity, or potency of the product.1 Therefore, providers and patients should be as confident in the safety and effectiveness of biosimilars as they are in the reference biologic.2
Another barrier to the wide adoption of biosimilar use is the prioritization of short-term savings, which can disincentivize competitors from entering or staying in the market, leading to less competition over time. Procurement policies that either drive biosimilar medicines to unsustainable price points or continue advantaging the reference biologic can discourage investment in future biosimilars. This should spark a sense of urgency to establish efficient regulatory policies and market incentives that push beyond the status quo and break down barriers to biosimilar adoption and ongoing utilization, especially given how vital these medications can be for patients’ lives and how cost-effective biosimilar options can be.
More support is needed to bring access to patients
Many patients still do not have access to treatment, and currently, eight of the top 10 drugs by spend in the U.S. are biologics. A successful competitive landscape for off-patent versions of these top-spend products is critical to the long-term viability of U.S. healthcare, including the sustainability of the Medicare program, and to help patients managing the financial demands of treatment. The acceptance and availability of biosimilars is vital to ensure a broad level of access in today’s complex healthcare environment for patients regardless of their insurance status or plan. All stakeholders must work to raise awareness of the safety, efficacy and cost-saving potentials of biosimilars while also ensuring incentives are aligned within the healthcare system. Importantly, out of pocket costs for patients, reimbursement amounts for physicians and payer incentives must be structured to encourage and support increased utilization and broader access to biosimilars without threatening the sustainability of robust biologic competition.
Viatris is committed to pushing for a stronger, more robust system for access to biosimilar medicines and supports policy solutions that correctly align incentives to ensure patients receive the benefit of lower-cost biosimilars. Considerations to accelerate the adoption of biosimilars include the enhancement to physician reimbursement for biosimilars, payment models that allow physicians and the healthcare system to share in the savings achieved by prescribing biosimilar medicines and eliminating or reducing patient cost sharing for access to these lower cost treatments.
Viatris is dedicated to the research and development of new biosimilars, strategic partnerships and collaborations, and policy reform around the globe. Viatris has endeavored to search for and discover new biosimilar candidates to expand its portfolio and bring more treatment options to market for as long as there are people without access to treatment.
1US Food and Drug Administration. Biosimilar Regulatory Review and Approval. https://www.fda.gov/media/151061/download. Accessed October 15, 2021.
2US Food and Drug Administration. Biosimilars are Safe and Effective Treatment Options. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars. Accessed October 15, 2021.