30 November 2023

Navigating Biosimilar Medicines Policies in EU Healthcare

Europe’s healthcare systems confront formidable challenges, imperilling access, affordability, and quality. Factors like an aging population, increased disease burden, and high costs of innovative medicines prompt policymakers to reevaluate spending. Amid this landscape, biosimilar medicines, introduced in 2004, play a pivotal role in offering safe clinical experiences.


In the European Union (EU), biosimilar medicines require the European Medicines Agency (EMA) approval. Pricing and reimbursement, crucial for fiscal sustainability, are the Member States’ responsibility.


Key Policies Governing Biosimilar Medicines are:

  1. External Reference Pricing (ERP): Aligns prices with comparable countries.
  2. Set % Below Originator Price: Mandates a percentage below the originator medicine’s price.
  3. Reference Groups: Determines prices based on a predefined group of medicines.
  4. Maximum Price: Imposes a predefined upper limit for generic medicines.
  5. Negotiation: Involves price negotiations between the company and payers.


Policy Recommendations are:

  1. Optimizing Competition: Policymakers must ensure frameworks support competition through authorized biosimilar use across all therapy areas.
  2. Balanced Price Control Measures: Given ERP’s impact on sustainability, balanced price controls with biosimilar use incentives are crucial.
  3. European-Wide Legal Guidance: Advocacy for legal guidance on medicines procurement covering security of supply, Most Economically Advantageous Tender (MEAT) criteria, and biosimilar competition.
  4. Enhancing Biosimilar Uptake: Efforts are needed to translate scientific evidence into biosimilar use guidance for Healthcare Professionals, engage in continuous outreach, and introduce tailored incentives.


A robust social media plan accompanies the report, leveraging various platforms to disseminate information and raise awareness about the findings and policy recommendations.