Current Trends in Technology and Regulatory Landscapes for Developing and Bringing Generics and Innovative Medicines to Market

09:30 - 10:05

  • Current technology and regulatory trends in the pharmaceutical industry fostering the advancement of complex generics and innovative medicines 
  • Challenges faced during the development paradigm of Complex Generic injectables and review of analytical/formulation, bioequivalence and regulatory complexity.
  • Leveraging use of regulatory guidances for development of complex products and synthetic peptides
  • Balance between innovation and risk in relation to complex generics and products developed via 505b2 regulatory pathway

This presentation will provide an overview of current technology and regulatory trends in the pharmaceutical industry fostering the advancement of complex generics and innovative medicines. 

Over the last decade there has been increased emphasis in developing complex generics via 505j regulatory pathway and innovative medicines following a 505b2 regulatory pathway with an increased focus on injectables and combination products.

An overview of complex injectables and the challenges faced during the development paradigm including sources of complexity (API and Excipients, formulation, manufacturing, analytical), characterization, design and control, challenges in bioequivalence and regulatory complexity in development as well as most recent regulatory guidances for complex products and synthetic peptides will be discussed.

Lastly, the interplay between innovation and risk in relation to complex generics and products developed via 505b2 regulatory pathway will be elaborated upon.

Rosario LoBrutto, Head of Scientific Affairs, Sandoz