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PANEL DISCUSSION: Regulatory Pathways for Specialty/ Complex Generics

(L-R) Dr Pawan Bhat, Executive VP, Technical Operations, Natco Pharma; Dr Raveendra Pai, Vice President, Formulation Development, Glenmark Pharma; Dr Vinay Nayak, Executive Director, Marksans Pharma; Dr Rakesh Kumar Bhasin, VP-Generic Formulation, Biocon; and Munish Talwar, VP, Pharma Research, Lupin

The first panel discussion at FDD Conclave 2018 was on Regulatory Pathways for Specialty/ Complex Generics. The panel was moderated by Dr Vinay Nayak, Executive Director, Marksans Pharma. Dr Rakesh kumar Bhasin, VP Generic Formulation, Biocon; Dr Raveendra Pai, VP, Formulation Development, Glenmark Pharma; Munish Talwar, VP, Pharma Research, Lupin and Dr Pawan Bhat, Executive VP, Technical Operations, Natco Pharma were the panelists.

Dr Nayak gave an overview on the subject at hand and  said that it is difficult to establish complex generics’ therapeutic equivalence as defined in the traditional generic medicines of the orange book. Some clinical studies and safety profiles need to be done at much higher levels to establish these complex generics. The complexities in these medicines can be in the form of APIs, formulations, devices, capsules, or drug delivery system.”

Dr Pai elaborated on the definition and classification of complex generics and briefed the audience on the challenges involved in the development of complex generics. He said, “There are challenges related to time, cost and risks.” He informed that moreover, because of their complex nature, FDA or other regulatory agencies also become more particular about scrutinising the dossier. Often, there is a lack of guidance from the regulatory agencies, especially related to new molecules, which makes it difficult for the development of complex generics.  Therefore, companies need to identify new commercial strategies aided by regulatory strategies for targeted markets to address unmet patient needs. In other words, to work on complex generics, we should  assist in creating regulatory strategies. Complex generics is about understanding the product, understanding the chemistry and a host of other things.

Dr Bhat shared his experiences, case studies and challenges faced while developing complex generics. The major complication that he faced was the changing guidance by FDA periodically. Their expectations in terms of meeting their criteria of bioequivalence kept changing over time. However,  the best thing is that FDA is providing a mechanism of pre-ANDA meeting. This is a new concept for the industry.”

Taking the discussion further, Dr Bhasin agreed with rest of the panelists that a major challenge in the development of complex generics is the regulatory pathway. He said, while working on complex generics it is better to be in touch with the FDA directly each time to get more clarity. He also informed that there are three important points to be considered while dealing with complex generics i.e. formulation development, regulatory strategies and clinical endpipes.

Talwar spoke on the complexity faced in the WHO markets and ROW markets. He said, “When we look at the US FDA there are clear defined guidelines but when we look at other markets the guidelines are not clear, so the complexity increases. The complexity for the formulators, apart from the regulatory pathways, start from the formulation itself.”

The panelists further answered a few questions raised by the audience related to regulatory strategies and pre ANDA meeting.

An interactive and enrapt audience at FDD Conclave 2018

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