Excerpt from Mylan Q2 2017 earning call transcript
Regarding delay in glargine filing with FDA
From the US commercial manufacturing strategy point of view, we have decided to include the manufacturing site variations from Bangalore to Malaysia up front in the application rather than as a post-approval change. We are meeting with the FDA very shortly to reach agreement regarding their expectation in this regard for the US filing.
Regarding Pegfilgrastim (Neulasta)
We continue to work with FDA on the science as well as on the GMP front. And as you know, we have not factored in any revenues even in 2018 in any meaningful way from biosimilars. But if there is one upside which I can see from biosimilars and where how the competitive landscape is lining up between other different players who are ahead of us, Neulasta might be the one. But we’ll give you more visibility as we go along.