Biologic medications are an integral, crucial, and effective part of medical management for many life-threatening diseases and conditions, including cancer. As a recent position paper by the European Society for Medical Oncology (ESMO) points out, the anticancer market is expected to pass the €140 billion (apx. $157 billion) by 2020.
Biologic medications are an integral, crucial, and effective part of medical management for many life-threatening diseases and conditions, including cancer. As a recent position paper by the European Society for Medical Oncology (ESMO) points out, the anticancer market is expected to pass the €140 billion (apx. $157 billion) by 2020, forcing nations around the world to confront the challenge of healthcare-system sustainability and patient access to these important medications. “Biological and medicinal products, or those whose active substance is made by a living organism, will represent 19% [to] 20% of the total global share of pharmaceutical sales by 2017, and thus form an essential part of the anticancer medicines offering,” ESMO explains.
Biosimilars, typically marketed at discounts relative to originator drugs, present a necessary opportunity for patients, physicians, and healthcare systems to positively impact the financial sustainability of global health systems when they are developed in clinically suitable ways, manufactured to correct standards, and used appropriately. Biosimilar clinical development must be recognized as an opportunity for healthcare in light of potential savings in a future where these drugs could compete with originator drugs, as noted by Emilio Bria (University of Verona) and Pierfranco Conte (University of Padua and Instituto Oncologico Veneto) in an accompanying editorial.
As the majority of monoclonal antibodies are due to reach patent expiry by 2020, the oncology landscape faces changes, ESMO notes. To ensure that patients are being prescribed the safest, most effective treatments possible, all key players must understand the complexities of biosimilars and make decisions in patients’ best interests. In addition, it is important to increase confidence in biosimilars among prescribers and patients so that continued adoption and uptake of biosimilars results in greater patient access to important biologic treatments.
The position paper, published in January 2017 in ESMO Open, describes issues concerning biosimilars that are particularly relevant to the oncology field:
The introduction of biosimilars is expected to have a cumulative potential savings of €50 billion to €100 billion by 2020. ESMO recommends monitoring the potential impacts of biosimilars on financial burdens in health care, keeping in mind that the potential savings has a direct correlation with the successful uptake of biosimilars. “Globally, the next 5 years will be important for biosimilars, for their uptake and their impact on healthcare systems,” the paper concludes.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability
April 30th 2024During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.