Module 9 2024

05/09/2024

CONCLUSION

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Conclusions

• EU and US apply very definitions to “Biological Medicine”

• US regulations introduce concepts novel to EU

• Patent dance

• Interchangeability

• Despite Efforts towards harmonisation FDA and CHMP can take different stances

• Variability is inherent to Biologicals; it is critical to understand the variability of the reference product over an extended time period • Generating meaningful clinical data can also be challenging and value of comparative efficacy data required by regulators questionable where is PK , safety and immunogenicity data may be more meaningful as efficacy studies lack sensitivity

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