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The battle is now shifting to whether biosimilars should have generic names different from that of the reference products.
The battle now shifts to whether biosimilars should have generic names different from those of the reference products.
Test products and reference products are needed for this study.
Commercially available reference products were procured [7] as adhesive controls (Table 3).
The identity of [18F]FEt-AMC13 [18F]FEt-AMC135, and [18F]FBu-AMC15 was also confirmed by co-elution with reference products.
The mean plasma diazoxide concentration-time profiles for the test and reference products are shown in Fig. 2.
The median (range) of Tmax for the test and reference products was 4.0 (1.0–18.0) and 4.0 (2.0 9.0) hours, respectively.
Both Test and Reference products were well tolerated, with no serious AEs and no relevant differences in safety profiles.
Existing approaches relate development risks to the share of new development and the organizational origin of the used reference products.
Biosimilars will be highly similar to their reference products, but unlike generic drugs, not identical.
A point of dicussion is that all children did well on the reference products before inclusion.
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