Government policies to maximize social benefit of biosimilars in countries with restricted access to biologicals

Biosimilars/Research | Posted 30/03/2018 post-comment0 Post your comment

The potential value of biosimilars is dependent on patient access to originator biologicals in a given country. If the originator biological is reimbursed without any volume and access restrictions, the main objective of using biosimilars is to generate savings in health expenditures without compromising health outcomes. This disinvestment scenario is mainly applicable for higher income countries. If the original biological product is reimbursed with volume and access restrictions, the main objective of biosimilars is to treat more patients from the same healthcare budget, and hence generate more health gain. This special investment scenario is applicable for lower income European Union (EU) Member States and other middle-income countries. If the originator biological is not reimbursed at all, more affordable biosimilars may create an opportunity for public reimbursement, however, incremental budget is needed to generate more health gain. This investment scenario is applicable for low-income countries [1].


Payers and policymakers should take a strategic approach and focus on interventions in the following key areas to maximize the societal benefit of biosimilars especially in countries with restricted access to originator biologicals.

1)    Public administration of biosimilars

  • Expedited pricing and reimbursement process should facilitate the timely market entry of biosimilars.
  • Administrative tools and policy measures should be introduced to incentivize the choice for more affordable biosimilars.

2)    Clinical guidelines

  • Multisource biologicals should be the first-line biological therapy for all patients. More expensive patented biologicals with no proven significant clinical benefit compared to biosimilars should only be second-line options.
  • Single switch of patients from an originator biological to its more affordable biosimilar alternative under medical supervision should be mandated after patent expiry.
  • Physicians should not only be informed about scientific evidence on biosimilars but also guided on how to educate appropriately their patients on these medicines.

3)    Evidence base for policy decisions

  • Cost-effectiveness or cost-utility analysis should be applied to judge the full economic value of biosimilars, except in those cases when biosimilar medicines are compared to their originator biological alternative for treatment-naïve patients.
  • Budget impact analysis should be applied to estimate: 1) the savings from biosimilars, if there is no patient access limit to biologicals; or 2) the incremental budget, if patient access to biologicals is restricted.

4)    Management of uncertainty related to policy decisions

  • Ex-ante risk management: threshold for the risk of immunogenicity may be calculated, where not switching patients to biosimilars is the preferred option from the payers’ perspective.
  • Ex-post risk management: vigorous pharmacovigilance data collection and risk-management plan should be mandated in case of increased risk of immunogenicity. The risk management plan may even include risk-sharing agreements with manufacturers of biosimilars.

The key success criterion of public health programmes is how to improve the utilization and persistence with more affordable biosimilars.

Conflict of interest
Syreon Research Institute received financial support from Medicines for Europe to prepare the original research paper [1]. The authors summarized their independent professional opinions and take full responsibility for potential errors in the manuscript.

Abstracted by András Inotai, PhD; Marcell Csanádi, MSc; and Zoltán Kaló, PhD; Syreon Research Institute, Budapest, Hungary.

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1. Inotai A, Csanádi M, Vitezic D, et al. Policy practices to maximise social benefit from biosimilars. J Bioequiv Availab. 2017;9(4):467-72.

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