Tuesday, September 10, 2013

Can Cipla make it in Respiratory Generics race, as Advair Generic Draft Guidance made available by the USFDA

The long-awaited draft guidance for generic Advair has been made available by the FDA. For filing an ANDA ( a bioequivalent substitutable copy), the basic things that generic companies would  need to focus on is 
1) The device should have similar size and shape, with similar operating steps and number of doses
2) Similar In-vitro performance as demonstrated by the emitted dose, aerodynamic particle size distribution and comparable resistance - This can be confirmed by invitro studies, which should demonstrate whether or not the inhaler is releasing the full dose of drug per administration and whether or not the distribution and size of particles released  are similar
3) Equivalent Systemic exposure, which will be based on pharmacokinetic data
4) Equivalent local delivery, which will be confirmed through a clinical study (double blind randomised, placebo controlled). The endpoint of the study would be FEV1:
  • Area under the FEV1 curve 0-12 hrs post dosing, 
  • FEV1 measured in the morning prior to dosing on the last day of 4-week treatment
5) Manufacturing Steps and process should ensure accurate powder filling and device assembly.

Advair Generic is a big opportunity for Generic players. Advair accounts for c. 20% of GSK's sales (2012 sales £5,046 mn, of which £2,533 mn derived from the US). From a Cipla perspective, the key hurdle would be demonstrating similarity of the device. Other important players pursuing the respiratory generic opportunity include Mylan, Teva and Sandoz/Vectura. 

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