Biosimilar switching and related medical liability

Area of Science:

• Pharmacology
• Medical Law
• Patient Safety

Background:

• Biosimilars offer alternatives to originator biologics but are not equivalent.
• Patient transitions to biosimilars introduce unique considerations for medical liability.
• Differentiating between naïve and non-naïve patients is critical for treatment decisions.

Purpose of the Study:

• To analyze the implications of medical liability when patients transition to biosimilars.
• To explore the differences in physician decision-making for naïve versus non-naïve patients.
• To propose strategies for managing patient safety and informed consent in biosimilar use.

Main Methods:

• Comparative analysis of legal and clinical frameworks for originator biologics, generics, and biosimilars.
• Review of patient transition scenarios, distinguishing between naïve and non-naïve populations.
• Exploration of ethical considerations regarding informed consent and shared decision-making.

Main Results:

• Medical liability distribution differs significantly for biosimilars compared to originators and generics.
• Physician choices involve known risks for naïve patients but introduce unknown responses when switching non-naïve patients.
• Informed consent and shared decision-making are vital for managing patient transitions to biosimilars.

Conclusions:

• Physicians should engage patients in shared decision-making and obtain informed consent when prescribing biosimilars, particularly for non-naïve patients.
• A supranational database for real-world data on biological medicine use could enhance post-market surveillance and patient safety.
• The evolving biosimilar legislation necessitates clear guidelines on liability and patient communication.