Factors contributing to long-term sustainability of biosimilars

Home/Reports | Posted 31/05/2019 post-comment0

The factors that may contribute to the long-term sustainability of the biosimilars market in Europe were presented by Murray Aitken of the IQVIA Institute for Human Data Science at the 17th Biosimilar Medicines Conference.


He explained how a multi-stakeholder view of sustainability in the biosimilars marketplace incorporates multiple perspectives, and biosimilar sustainability improves patient access and physician prescription choice of safe and high quality biologicals. This should be made possible in a framework that considers the ongoing needs of all stakeholders (patients, healthcare professionals/providers, payers and manufacturers). It should also provide a means to manage existing healthcare budgets while safeguarding a healthy level of competition and supply.

Factors that contribute to providing the long-term sustainability of biosimilars market in Europe, according to Aitken, include:

Regulatory environment and clinical guidelines
• Time to first biosimilar sales
• Treatment guidelines for biosimilar use
• Physician switching policies
• No pharmacist automatic substitution policies

Awareness and education
• Comprehensive training/education for patients
• Comprehensive training/education for physicians

Product quality and supply
• No safety or quality control alerts
• No supply shortages

• Prescription quotas or provider incentives promoting biosimilar use and not restricting physician choice

Pricing rules and dynamics
• No mandatory price cut policy for originator
• No price reference policy at molecule level

Purchasing mechanisms
• Length of contracts
• Tender timing relative to biosimilar entry
• Tender lead time
• Number of winners
• Winner decision criteria beyond price

Conflict of interest
The author of the presentation [1] did not provide any conflict of interest statement.

Related articles
The level of biosimilars competition in Europe varies

Biosimilars market and opportunities in Europe

Challenges for biosimilar sustainability in Europe


1. Aitken M. Advancing long-term biosimilar sustainability in Europe: the challenges ahead. Medicines for Europe 17th Biosimilar Medicines Conference; 28-29 March 2019; Amsterdam, The Netherlands. 

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