Just related to somatropine, or could it affect all growth inducing therapies there
(about the side by side comparison study remarks)
seems is just meant for similar somatropin products and how they compare to each other
or thats how i read it
so dont think that affects things...
HOWEVER the huge time difference between the 87 day for trca for COMP designation.. and the 30 days for INSM COMP designation is still very interesting
------------------------------------------------
the time being, analytical characterisation and a limited non-clinical programme
alone cannot establish therapeutic equivalence of a similar biological medicinal product
with the reference product. In addition, IGF-1 is no established surrogate marker for
efficacy. Therefore, a clinical equivalence trial in a sensitive model is necessary. GH
deficient children are the preferred models because they are GH sensitive and represent
the classic indication for GH therapy for which most experience has been gathered and
for which equivalence margins may be easiest to define. However, a study in GH
deficient adults is principally possible.
The voiced fear that the requirement for a comparative clinical trial is a major
development obstacle is not confirmed by real life experience. In this respect it should be
pointed out that the applicant of a ‘biosimilar’ rHuGH will need to perform only one
rigorous comparative clinical trial in one indication with the possibility of extrapolation
to the other indications of the reference product.
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