Sustainable Biosimilar Markets Achieve Widespread Market Uptake Through Collective Action

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Collective action theory was a proposed solution for stakeholder disagreements stalling biosimilar uptake because it fosters collaboration and achieves widespread biosimilar use for long-term benefits.

A commentary article focused on various approaches applied as long-term solutions for biosimilar markets. Several trends raise concerns about the biosimilar market, such as a limited pipeline of new drugs in development, a focus on developing biosimilars only for high profit areas, and an increasing number of biosimilars being discontinued or withdrawn.

Disagreements surrounding stakeholder strategies attempted to regulate the supply and demand chain of biosimilars. Usually, stakeholder disagreements revolve around competing interests that come into conflict in the short term and undermine joint long-term goals.

On the supply side, payers and health care site managers are looking to reduce costs by decreasing drug prices through biosimilar savings, a short-term objective. Concerns were addressed by stakeholders surrounding mainly potentially anticompetitive procurement practices that reinforce the originators’ market dominance while tendering procedures that lead to selections of a biosimilar product as a single winner.

With negative effects on the competition environment for biosimilars in mind, care providers have raised awareness on the impact limited competition has on continuity in the supply of biologics and ultimately, patient care. Supply issues, largely affecting the market of generic medicines could soon extend to biosimilar markets, increasing the number of biosimilar withdrawals and discontinuations.

The demand side includes policy and decision-makers that advocate for biosimilar policies to increase early uptake and generate substantial savings. Application of mandated nationwide switch protocols were one solution to drive uptake. It should be noted that even if solutions neglect sustainability concepts, it is still capable of producing short-term benefits.

Proposed solutions, particularly mandatory switching protocols, often face resistance from health care professionals and patients. Unlike payers and policymakers focused on cost savings, health care professionals prioritize patient care and may disagree with rapid switches that lack sufficient time or resources. Similarly, patients are hesitant to switch therapies unless they see clear benefits in terms of accessibility and affordability.

Successful community driven initiatives have been successful based on their ability to promote multi-stakeholder consensus efforts. Although, challenges included the scale of these initiatives while ensuring durability is in the absence of a detailed oriented understanding of the required principles, and socioeconomic and policy environments.

Communication between stakeholders surrounding biosimilar savings and the reallocation of savings generated some differing perspectives. Some stakeholders suggested the need for greater transparency and local reallocation strategies while others examined the totality of generated savings that should meet the demand of the central health administration.

Based on collective action theory, “social dilemmas” can be prevailed if stakeholders were more open to “cooperate” design and implementation strategies for long term societal benefits. This potential solution is relevant in investigating collective action theory as a conceptual framework to advise prospective policy reforms for biosimilars.

Newfound knowledge from the collective action theory was applied to support sustainable biosimilar markets. Collective efforts and joint responsibility of stakeholders in health care are requirements for creating a sustainable biosimilar market.

Effective policy frameworks rely on multistakeholder input, long-term visions, aligned incentives, cost benefit analysis, intergovernmental coordination, clear goals, and efficient complaint as well as outcome monitoring. Research shows past policies lacking these elements faced implementation hurdles.

More research is necessary to accurately measure how much stakeholders agree with the described sustainability principles and to develop a dependable framework that can be applied to specific situations in the biosimilar market. It's important to consider political and economic limitations, as they can make it difficult to apply theory into practice when evaluating individual cases.

Reference

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;1-5. doi:10.1007/s40259-024-00652-7