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In 2019, we are very optimistic about pharma generics: Gurudatta GG, Estima Pharma Solutions

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ET Health
09th January, 2019 15:14 IST
US FDA is giving a lot of importance to releasing complex generic guidelines with respect to injectables. Both Sun Pharma and Lupin are working on injectables, Gurudatta GG, Director & CEO, Estima Pharma Solutions, tells ET Now.

Edited excerpts:

What are the trends in the pharma industry right now? The Teva CEO overnight has said that there has been a dramatic change in the US pricing environment and that he expects to have a more stable situation hereafter. What is your view on the same?
Based on the published reports and the informations available from the US market, 2019 is going to be a stable environment for pharma with respect to US pricing pressure. In 2018 there was 10-12% price reduction with respect to the generic market. Maybe we can look at a maximum of 5% to 8% reduction this year. However, it depends upon the product selection.

What according to you has been the initial response to the speciality pipeline both for Lupin as well as Sun Pharma? Has it been quite strong for Sun Pharma?
With respect to the pipeline Sun Pharma is working on a lot of injectable products whereas US FDA also is giving a lot of importance by releasing complex generic guidelines with respect to injectables. Sun Pharma is definitely taking advantage out of it and they are working on a lot of speciality generic injectable products. From this, they can get a better margin than the present me-too products. In the same way, even Lupin is working on similar lines and concentrating on the injectable products.

What is the way forward? Both of you are very optimistic about the scenario picking up for pharma currently given the global and local environment?
Yes absolutely. In 2019, we are very optimistic about pharma generics and because the US FDA has initiated GDUFA fees for the ANDA approvals, because of which they started initiating complex generic molecules.

They are even helping us facilitate pharma companies with respect to product development stages, pre-submission stages and FDAs, arranging the meetings with the pharma companies so that the approvals can come faster. Consider the earlier stage where ANDA approvals would have taken about 36 months and nowadays in 2018 it has been reduced drastically and the approvals are taking far shorter time. In preferred generics, we are getting approvals even within eight months, while generally, it takes 18 months to get the ANDA approvals because of which the pharma companies can be definitely optimistic.
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