Multiple Source Biosimilar Insulin, What's a Provider to Do?

Area of Science:

• Pharmacology
• Biotechnology
• Regulatory Science

Background:

• The U.S. FDA designates bioequivalent generic products as AB substitutable, expecting identical therapeutic results to innovator products.
• Biological proteins like recombinant human insulin can exhibit molecular and structural differences between manufacturing sources, even if similar to innovator products.
• Subtle variations in biosimilar insulins may lead to different therapeutic outcomes compared to branded versions.

Purpose of the Study:

• To highlight potential therapeutic discrepancies between innovator and biosimilar insulin products.
• To underscore the need for more rigorous oversight of critical medical products, including biosimilar insulins.
• To advocate for healthcare providers to ensure patient access to safe, affordable, and quality-assured medical products.

Main Methods:

• Review of FDA designations for generic and biosimilar products.
• Analysis of potential molecular and structural differences in biological proteins.
• Evaluation of current quality oversight mechanisms for medical products.

Main Results:

• Differences in insulin molecules and accompanying structures between manufacturing sources can lead to varied therapeutic endpoints.
• Substitution of branded insulin with biosimilars may result in unpredictable glycemic control, increasing risks of hypoglycemia or hyperglycemia.
• Current self-oversight and post-market adverse event reporting may be insufficient for critical products like biosimilar insulin.

Conclusions:

• Vigorous oversight is essential for critical use products such as biosimilar insulin to prevent adverse events.
• Healthcare providers must champion patient access to consistent, quality-assured, and affordable medical products.
• Collaborating with nonprofit organizations for supply chain quality assurance offers a commonsense preventative solution.