Authors of a commentary piece propose solutions to sustainability issues for biosimilar markets and shed light on common sustainability challenges global markets face.
A commentary piece published in BioDrugs critiqued factors found to undermine biosimilar market sustainability and made recommendations for long-term solutions that could improve endangered markets.1
Although most stakeholders in the biosimilar space can agree that long-term market sustainability is a major concern, many disagree on the best policy approach to ensure a robust, competitive marketplace. Image credit: TStudious – stock.adobe.com
The development and marketing costs for biosimilars are significantly influenced by pricing and procurement practices that cause rapid price erosions. An IQVIA report highlighted that nearly one-third of high-sales biologics losing exclusivity in the next decade lack biosimilar candidates.2 Additionally, the same report found that the European Union could miss out on a minimum of €15 billion in cost savings from a lack of biosimilars for biologics about to lose exclusivity, which could have implications for overall treatment cost efficiency gains and medication availability.
This, coupled with limited commercial opportunities for many biologics, raises concerns about the long-term viability of biosimilar markets and what is needed to achieve sustainable competition. The purpose of the commentary piece was to raise awareness of vulnerabilities associated with some global biosimilar markets and difficulties with reaching consensus on long-term policy advancements.
When discussing disagreements on how to move sustainability efforts forward, there are 2 perspectives to consider: the supply side and the demand side.
On the supply side, payers and health care managers aim to reduce costs through significant price cuts and biosimilar savings, which can sometimes hurt long-term market competition. Concerns include anticompetitive procurement practices favoring originators and tendering procedures that select a single biosimilar winner. Limited competition may also disrupt biologic supply continuity and patient care, with biosimilar withdrawals and discontinuations potentially exacerbating these issues.
Policymakers have sometimes implemented top-down biosimilar policies to drive early uptake and savings, such as mandated switch protocols, such as those in Canada.3 Though beneficial short-term, these strategies are often unpopular with health care professionals and patients, who prefer avoiding therapy switches unless there are clear care quality and financial benefits, with some providers calling for more data on the safety of nonmedical switching.4
In the absence of central strategies, individual health care communities, such as Kaiser Permanente and the American Oncology Network (AON), have successfully implemented their initiatives, but scaling and sustaining these efforts remains challenging without supportive environments.5
“It’s imperative for formulary strategies to effectively navigate and overcome the dynamic challenges present in the biosimilar market…. We are all here for biosimilars and we need to come and work together to learn from each other—from the patients, to the payers, to the policy makers, to the providers—to ensure that we have a long-term plan to support our patient,” said Melody Chang, vice president of pharmacy operations at AON, during her presentation on AON’s successes at the Festival of Biologics.6
Disagreements also exist on how to communicate and reallocate biosimilar savings, with some advocating for transparency and local reallocation, while others prefer central health administration control. These conflicts, viewed as "social dilemmas," could be resolved through cooperative strategies that prioritize long-term societal benefits, as suggested by collective action theory.
Principles for managing local-scale Commons, initially applied to natural resources, are now being tested for broader applications, including health care. Despite challenges, this research is increasingly used in diverse domains like digital and space governance. Few examples currently apply collective action theory to health care, but interest is growing. Studies demonstrate applying collective action theory to health care reform.
This commentary suggests that multistakeholder-supported principles, based on collective action theory, can inform comprehensive frameworks for biosimilars. The authors stressed that future policy frameworks should involve multistakeholder panels, adopt long-term visions, design incentive systems aligned with stakeholder needs, evaluate cost-benefit balances, foster coordination across governance levels, define shared goals, and use policy outcome data to adapt frameworks.
Past policies lacking these principles faced implementation challenges, such as ineffective benefit-sharing strategies and compliance issues with top-down mandates. Identifying these principles is a step toward reconciling competing interests for long-term gain, although reforming biosimilar policy frameworks in Europe will be a multiyear process. European policy changes may influence global biosimilar markets, promoting sustainable practices.
Further research is needed to test stakeholder agreement on sustainability principles and build a biosimilar market framework. This should be tested through country-specific case studies, considering political and socioeconomic factors. A current project in Belgium and the UK has piloted cocreation workshops with health care stakeholders, encouraging proactive involvement.
The authors concluded, “It is pertinent to explore how to apply learnings of collective action theory to healthcare to motivate stakeholders to prioritize long-term solutions over short-term gains. We argue that a set of multistakeholder-supported principles can be formulated drawing on collective action theory to support sustainable biosimilar markets.”
References
1. Lacosta TB, Vulto AG, Turk F, Huys I, Simoens S. Can endangered biosimilar markets be rescued? The need to bridge competing interests for long‐term gain. BioDrugs. 2024;38(3):325-329. doi:10.1007/s40259-024-00652-7
2. Jeremias S. IQVIA highlights opportunity to cash in on biosimilars for biologics losing market exclusivity. The Center for Biosimilars®. November 29, 2024. Accessed June 25, 2024. https://www.centerforbiosimilars.com/view/iqvia-highlights-opportunity-to-cash-in-on-biosimilars-for-biologics-losing-market-exclusivity
3. Jeremias S. Prince Edward Island announces new biosimilar switching policy. The Center for Biosimilars. October 14, 2023. Accessed June 25, 2024. https://www.centerforbiosimilars.com/view/prince-edward-island-announces-new-biosimilar-switching-policy
4. Ferreri D. Gastroenterologists want more evidence on nonmedical switching. The Center for Biosimilars. May 6, 2020. Accessed June 25, 2025. https://www.centerforbiosimilars.com/view/gastroenterologists-want-more-evidence-on-nonmedical-switching
5. Hagen T. Samsung Bioepis executive comments on Kaiser Permanente’s biosimilar success. The Center for Biosimilars. September 6, 2020. Accessed June 25, 2024. https://www.centerforbiosimilars.com/view/samsung-bioepis-executive-comments-on-kaiser-permanente-s-biosimilar-success
6. Jeremias S. AON saves over $243 Million with high biosimilar adoption. The Center for Biosimilars. April 22, 2024. Accessed June 25, 2024. https://www.centerforbiosimilars.com/view/aon-saves-over-243-million-with-high-biosimilar-adoption
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