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IGBA’s Almeida On Patent Quality, Single Data Package Globally For Off-Patent Drugs

 
• By Anju Ghangurde

IGBA's secretary general, in an interview with Scrip, bolsters the case for enabling single global development of off-patent medicines and the acceptance of foreign comparators in bioequivalence studies as complex and niche therapeutics increasingly dot pharma’s pipeline. The global off-patent industry association, she maintained, is also “paying attention” to patent quality in various regions.

Dr Susana Almeida, secretary general of the International Generic and Biosimilar Medicines Association • Source: Indian Pharmaceutical Alliance

Dr Susana Almeida, secretary general of the International Generic and Biosimilar Medicines Association (IGBA), was at a summit in India recently where she discussed the importance of single global development (SGD) to the off-patent industry and its role in supporting access and competitiveness of generic drugs, including complex therapies.

SGD essentially entails enabling manufacturers of off-patent drugs to prepare a single data package globally acceptable in all jurisdictions.

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