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Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability
Gregory C Davis1, John M Beals, Craig Johnson
1Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, IN 46285, USA. davis_gregory_c@lilly.com
Current Medical Research and Opinion
|May 30, 2009
Summary
Creating regulatory pathways for follow-on biologics (FOB) requires careful consideration of technical challenges. Extensive clinical evaluation is crucial for demonstrating FOB safety and efficacy, distinguishing similarity from interchangeability.
Area of Science:
- Biopharmaceutical Development
- Regulatory Science
Background:
- Global policymakers are developing regulatory pathways for follow-on biologics (FOB).
- FOB development presents unique technical challenges distinct from intra-manufacturer process changes.
- Historical industry-regulator discussions highlight limitations in extrapolating change-control flexibility to independently developed manufacturing processes.
Purpose of the Study:
- To provide recommendations on technical aspects for an FOB approval pathway.
- To address the complexities of evaluating independently developed manufacturing processes.
Main Methods:
- Commentary and expert opinion on regulatory and technical considerations.
- Analysis of comparability challenges between innovator and FOB products.
Main Results:
- Current analytical methods alone cannot fully assure FOB similarity to innovator products.
- FOB manufacturers lack innovator's developmental knowledge, necessitating comprehensive evaluation.
Conclusions:
- Extensive clinical evaluation is likely required to ensure FOB safety and efficacy.
- Marketing approval as a 'similar' product requires demonstrating safety and efficacy per regulatory standards.
- Interchangeability requires additional testing and market experience beyond similarity.
- Post-marketing surveillance is essential for confirming sustained clinical safety and efficacy before considering interchangeability.
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