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Can any one explain me What is "Essential similar Products" and is it
possible to enter into regulated market without doing BE studies.
Any help would be greatly appreciated.
Dr Ganesh Shetty.
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Your question of essentially similar product is really debatable, as
you have asked for potential of biowaiver, then in that case I would
give you one example wherein you need to be pharmaceutically equivalent
with that of innovator which you are targeting, secondly you should
have ratios of your excipient and drug proportional or linear (dose
weight proportional), as far as regulated market of US and EU is
concerned, they may differ slightly so its up to you how you interpret
Pharmaceutically Equivalent Product (Dose, dosage form, Route of
US- dose weight Proportional
EU- dose weight Proportional and similar or proportional in ratios of
Excipient to Drug and to Tablet weight.
E.g. with respect to EU:
The ratio between amount of active substance and excipients is the same
or in the case of preparations containing a low concentrations of the
active substance ( Less than 5%) the ratio between the amount of
excipients is similar ( Here in this case the ratio between strengths
differ slightly e.g. D:E 1.16:98.84,1.18:98.82,1.76:98.23,2.35:96.45).
The pink indicates drug % or ratio and Blue indicates excipient % or
ratio) this indicates that our generic equivalent is differing in % or
ratio of drug and % or ratio of excipients within strengths, but this
difference in % or ratio is very low.
I was interested to know whether is there any limit which indicates the
maximum % deviation is allowed with respect to drug and excipient ratio
to become eligible for Biowaiver. (Ans: you need to be same in ratios,
you may have to change the weight of tablets to make the ratios
proportional or you can make a case on case basis and discuss the
matter with FDA)
With respect to US: Only dose Weight Proportional (No need to be
similar in terms of ratios)
I hope this makes you to understand the formulation biowaiver w.r.t.
dose weight proportionality
I hop I have made you clear, if not please let me know. If I am wrong
somewhere please do correct me
Novel Drug Delivery Systems
Glenmark Research Center
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Based on BCS Class 1, i believe OGD -CDER of US FDA is giving clearance
if comparative dissolution profile is submitted.
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