E-DRUG: therapeutic equivalence of different dosage forms?
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dear E-druggers,
I would like to ask your help and advice regarding a question I have
been requested to answer. Company A, is producing the generic medicine
X, an antifungal, IV infusion, packed as 100 ml. Company B, after
marketing the original, brand product (to which X is equivalent) packed
as 100 ml, now is marketing also a 200 ml package, the same
concentration (y mg/ml). Now company A, is asking us whether there are
therapeutical differences between these two packages. In other words,
there is any therapeutic difference between 2x 100 ml of generic and 200
ml of brand product, both having the same concentration, and the product
being an IV infusion? In a tender for 200 ml, could company A
participate with its 100 ml form?
For me the answer seems self-obvious, but I could be wrong, that is why
I am asking your help.
Thank you,
Best regards,
Robert Ancuceanu,
Pharmaceutical General Directorate
Ministry of Health
Bucharest, Romania,
1-3 Cristian Popisteanu Street
tel: 040 21 3072550
e-mail: ancuceanu77@ifrance.com
anro@ms.ro
[moderator's comment: IV fluids should be 100% available? Anyway, let us hear from the drug regulators what they think about 2x100 vs 1x200mL. WB]