[Interchangeability and substitution of biosimilars]

Area of Science:

• Biopharmaceutical Science
• Pharmacoeconomics
• Clinical Pharmacology

Background:

• Biosimilars are highly similar to reference biologic medicines in terms of safety, efficacy, and quality.
• Real-world clinical experience and scientific evidence support the interchangeability of biosimilars.
• Despite evidence, biosimilar substitution faces significant resistance in many countries, impacting healthcare costs.

Purpose of the Study:

• To evaluate the scientific basis for biosimilar interchangeability.
• To address the economic implications of biosimilar substitution in healthcare.
• To highlight the need for improved information dissemination regarding biosimilars.

Main Methods:

• Review of broad scientific evidence on biosimilar efficacy and tolerance.
• Analysis of clinical experiences with biosimilar use in real-world settings.
• Assessment of economic impact and cost-saving potential of biosimilar substitution.

Main Results:

• Scientific evidence and clinical data confirm no reduction in efficacy or change in tolerance for biosimilars compared to originators.
• Biosimilar substitution offers substantial cost savings, crucial for managing escalating healthcare expenditures.
• European regulatory evaluation confirms the high quality of authorized biosimilars.

Conclusions:

• The interchangeability of biosimilars is scientifically sound and supported by extensive data.
• Overcoming reluctance to biosimilar substitution is essential for realizing significant healthcare savings.
• Enhanced information for healthcare professionals and patients is critical for promoting biosimilar adoption.