Overview of biosimilar medicines in Spain: market dynamics, policies, evidence-based insights and avenues for a sustainable market

ABSTRACT

Introduction

After 17 years on the market, biosimilar medicines have contributed significantly to the sustainability of healthcare in Spain, providing cost-effective treatment options and savings of more than €1 billion by 2022 alone. To fully exploit this potential and meet the European pharmaceutical strategy’s objectives of increased access and a resilient supply chain, Member States need to optimize their biosimilars policies.

Areas covered

We conducted an exhaustive review of biosimilar medicines in Spain, first describing their regulatory framework. Biosimilar policies at both national and regional level have been collected and updated figures on the biosimilars market are provided based on official data. Knowledge and acceptance of biosimilar medicines among patients and medical societies based on biosimilar positioning documents is reviewed. National evidence on the contribution of biosimilars to savings and sustainability is also included in this study.

Expert opinion

In Spain, there is a need to further build confidence in biosimilars, develop a strong national biosimilars policy and address regional variability, improve public procurement and adapt clinical practice guidelines following the commercialization of biosimilars. By implementing a holistic and evidence-based policy, Spain can fully exploit the benefits of biosimilar medicines and ensure better and equitable access across the healthcare system.

KEYWORDS:

• Biosimilar
• biological
• medicines
• off-patent
• Spain
• pharmaceutical market
• pharmaceutical policy

Article highlights

• Biosimilars have proven their contribution to the sustainability of the Spanish NHS and to a timelier access of patients to biological therapies.

• The decentralization of the NHS also shapes the biosimilars market: lack of a national strategy and great variability by region in terms of market share and promotion policies implemented.

• The Spanish biosimilars market is largely hospital-based and variability by active ingredient and setting (hospital vs. retail) is observed.

• The confidence of HCPs and patients in biosimilars is a pending challenge.

• Policy makers have taken different approaches to support the biosimilars market with variable outcomes so a well-defined strategy and a systematic prioritization process involving multiple stakeholders is recommended.

• Value-based procurement, benefit-sharing incentives, transparency and educational activities together could be an optimal approach leading to increased utilization.

Abbreviations

ACs, Autonomous Communities; AEMPS, Spanish Agency of Medicines and Medical Devices; AIReF, Independent Authority for Fiscal Responsibility; BIA, Budget Impact Analysis; CHMP, Committee for Medicinal Products for Human Use; CIMP, Inter-Ministerial Commission for Pharmaceutical Prices; CPGs, Clinical Practice Guidelines. DDD, Defined Daily Dose; EMA, European Medicines Agency; EU, European Union; HMA, Heads of Medicines Agencies; IMID, Immune-Mediated Inflammatory Diseases; INGESA, National Institute of Health Management; IV, intravenous; ISCIII, Carlos III Health Institute; MoH, Ministry of Health; MRP, Maximum Reference Price; NICE, National Institute for Care and Excellence; NHS, National Health System.

Declaration of interest

I Río-Álvarez and E Cruz-Martos are employees of the Spanish Biosimilar Medicines Association. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Both authors contributed equally and have read and agreed to the published version of the manuscript.

Acknowledgments

The authors would like to thank the Directorate-General for Pharmacy and Health Products within the Spanish Ministry of Health for data provision. The content of this manuscript is the responsibility of the authors and does not represent the official views of the institutions acknowledged in this section.

Additional information

Funding

This paper was not funded.