Biosimilar insulins: guidance for data interpretation by clinicians and users

Area of Science:

• Pharmaceutical Science
• Endocrinology
• Biotechnology

Background:

• Biosimilar insulins are copies of existing insulins, aiming to increase market competition and reduce costs.
• Limited public data on manufacturing processes hinders independent assessment of biosimilar insulin quality and batch-to-batch consistency.
• Current preclinical and clinical assessments may lack sensitivity to detect subtle differences between insulins.

Purpose of the Study:

• To evaluate the current understanding and challenges associated with biosimilar insulin assessment.
• To identify limitations in existing methods for determining biosimilarity and clinical equivalence.
• To propose recommendations for enhancing the transparency and rigor of biosimilar insulin evaluation.

Main Methods:

• Review of preclinical assessments (physico-chemical stability, animal pharmacodynamics/pharmacokinetics, immunogenicity).
• Analysis of clinical studies, including human pharmacokinetic/pharmacodynamic (glucose clamp) assessments.
• Evaluation of clinical efficacy and safety outcome measures (e.g., HbA1c, hypoglycemia).

Main Results:

• Preclinical and clinical methods may not be sufficiently sensitive to detect critical differences in biosimilar insulins.
• Published data on manufacturing, batch variability, and device compatibility are scarce.
• Current outcome measures for efficacy and safety have limitations in differentiating insulins.

Conclusions:

• Publicly sharing all comparative data is essential for independent assessment.
• Systematic clinical studies are needed to address batch-to-batch variability, device compatibility, interchangeability, and long-term outcomes.
• Despite challenges, biosimilar insulins are a valuable addition to diabetes therapy with a transparent approach.