Biosimilars
topic on 2 shows · 2 statements across 2 episodes
WTF is with Nikhil Kamath 
All-In
2 statements about Biosimilars, every show
FDA reduces biosimilar approval timeline from up to 8 years to 2.5
“We have changed the requirements so that we use the same principles we use for small molecules If you are structurally the same as a small molecule branded drug, we're going to approve you with some other stipulations. And so we are reducing the cost of R&D of…”
Mazumdar-Shaw: Entering biosimilars now would severely hurt Indian pharma earnings
“If any Indian pharmaceutical company wants to now venture into biosimilars, like I have done, it will, you know, have a huge impact on their EBITDA and their earnings, which I don't think anyone wants to do at this point in time.”