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Fly News Breaks for September 19, 2018
TEVA, AMGN, MYL, JAZZ, AMRX
Sep 19, 2018 | 08:38 EDT
Leerink analyst Ami Fadia tells investors in a research note that she is "incrementally positive" on the state of the generics industry following investor meetings with the management teams from Outperform-rated Amneal (AMRX), Pfenex and Teligent. Fadia says a key takeaway from the teams is that the FDA is placing additional emphasis on reviewing and approving complex generics, and while there is starting to be more first-to-market approvals, there are also more approvals for the second and third generic entrants. Additionally, Fadia says the complex generic opportunity will likely be characterized by a slower-than-typical launch ramp, but also extended duration of meaningful financial contribution due to less overall competitors vs that for oral-solid generics and that while companies still regard biosimilar assets as attractive, the low penetration for biosimilar Remicade in the U.S., Mylan's (MYL) slow start with Fulphila and extended litigation timelines mean management teams looking to participate in this space are taking a more prudent approach and minimizing their upfront investment.
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