Generics: Challenges summary for a growing sector of pharmaceuticals
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Transcript of Generics: Challenges summary for a growing sector of pharmaceuticals
![Page 1: Generics: Challenges summary for a growing sector of pharmaceuticals](https://reader036.fdocuments.us/reader036/viewer/2022082815/55d110a9bb61eb03508b4568/html5/thumbnails/1.jpg)
Challenges for Generic Companies on Grounds of Quality, Efficacy and Safety
M. Faisal Shahid
University of Karachi
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Generic Drug
A drug formulation, equivalent to an innovator brand standard in terms of efficacy, therapeutic effect with same strength, dosage and formulation
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Quality Issues
Commoditization, and vast reforms in regulated and unregulated markets
Increased competition on prices
Complex product portfolios
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Safety
Top Five Major Issues for Deviations:
Air Monitoring and Ventilation Issues Essential Equipment Failures Set Point Instrument Drifts/Maintenance Design Checks and Plant Operations/Scale ups Failures due to Flow Induced Vibrations
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Efficacy
Bio-availibility deviations in formulations Factors:
Process scale up problems Lack of compliance API sources Product closure/storage parameters
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Biologics
Sero-Rico, but uncertain results Hot cake in regulated markets High risk, high gains High technical and analytical requirements Will account for 8/10 of top drugs by 2016
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Conclusions
Generic sector market share shall increase in coming decade
Biologics and Bio-similars will dominate regulated markets
With increasing regulatory support and framework, generic sector would flourish in third world states