Would 2 biosimilars, that have separately demonstrated interchangeability with the reference product, through adequate clinical designs (phase III trials with 2 arms, and at least three changes in the switching arm, as proposed by the FDA draft), be also interchangeable with each other?
Sorry but honestly I understand as if it is written in swahili language, i.e. I am afraid that I did not understand anything of your question. Please avoid abbreviations and tell what is "biosimilar" to you. Thanks. Are you involved in phase III clinical trials? You need a CRO* for that
* Clinical research Organization (CRO)
Yes. They should be interchangeable. Suppossing all the test phase III have been correctly performed. This interchangeability is only valid for the disease that has been tested for and not for off target effects.
Dear Dr. Franco, the WHO definition for Biosimilar:
A biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product. We already have several biosimilars approved by the main regulatory agencies.
I am not involved in clinical trials.
RP means Reference Product.
Thans Igor
As I see it the main issue is to demonstrate similarity in
quality, safety and efficacy. I would think that, just taking safety, you cannot go from preclinical stidues in animals to a phaase III trial in humans
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