Module 9 2021

22/03/2021

CONCLUSION

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CONCLUSIONS

• Physicochemical and biological data forms the foundation of the biosimilarity assessment; analyses should extend to the impact of formulation and container closure. • Variability is inherent to Biologicals; it is critical to understand the variability of the reference product over an extended time period • FDA and CHMP take different approaches to assessment of Quality attributes in determination of biosimilarity; FDA approach very restrictive. • In assessing potency it is appropriate to apply a range of orthogonal methods in order to ensure that as far as possible all subtle differences between biosimilar and reference product are detected. • Differences in Critical Quality attributes will need to be justified based potential and known impact on potency, PK, immunogenicity and safety

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