Dr Girish Jain, Head- Global R&D, Slayback Pharma and a veteran in the field of pharma R&D gave a very informative session on Complex Generics. His session demonstrated his experience and expertise across both, innovative and the generic pharma research space. Yet many complex drug products have relatively small market capitalisation and are less enticing for generic drug developers due to cost constraints, complexities in regulations and other factors. He also detailed the challenges in complex generics to ensure pharma equivalence, bioequivalence and therapeutic equivalence.
Highlighting that the FDA is helping the generic drugs industry to understand and comply with requirements of complex generics through workshops, he enlightened the audience on FDA’s key steps towards complex generics 2018-19 such as:
- Approval/TA of >1000 Generic drugs – 10 per cent are FIRST GENERICS (18 per cent of which are COMPLEX GENERICS) and 14 per cent of total stand for COMPLEX GENERICS. Approved the first generic Epinephrine Auto-injector
- Implemented a new pre-ANDA programme for complex generics per GDUFA II (92 pre-ANDA meeting requests)
- PSG’s – Issued 128 new and 117 revisions – 115 of them are for complex products
- Office of Bioequivalence collaborates with other CDER and OGD offices to consider new methodologies for demonstrating BE in complex dosage forms
He also gave an outlook on the GDUFA Regulatory Science Priorities FY2019 that include complex routes of delivery; complex active ingredients, formulations or dosage forms; complex drug device combinations, and tools and methodologies for BE and substitutability.
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