Biosimilars/Biologics : IND or IMPC CMC requirements
I have few doubts on below points w.r.to a biosimilar (mAb, liquid formulation product) clinical trials CMC requirements, any feedback on the same from experienced collegues would be appreciated
1.Do sponsor need to provide any In-use stability data in IV solutions before Phase 1 or phase 3?
2.How much real time stability data required before phase 1 and phase 3? is 1M data okay from CT batches along with some development stability data
3.What kind of stress stability required before phase 1 and phase 3? if required , do we need to do studies on both DS and DP or any one is okay?
4. Is hold time data required before phase 1 and phase 3? if yes is R&D data acceptable at this stage
5. When do inprocess samples validation is expected ? BLA or phase 3
6.Do FDA/EMA expects process/Prodcut specific HCP or generic kit use is acceptable?
7. how much Process development data expected before phase 1 and phase 3?
8. Is impurity identification or qualification (structure to function studies ) expected before phase 1 or phase 3?
9. Is media fill data expected before phase 1 or phase 3?
10. is filter valication studies data with DP/DS expected before phase 1 or phase 3?
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Maddigunta Sadasivarao
biocon limited
gugugram, haryana
India
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