Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Interesting, Neulasta biosim application from Novartis was withdrawn from the EMA. And that comes on the heels of a CRL for same biosim by the FDA back in July (which I wasn’t aware of until today). So that means there will be less competition w Rolontis when it becomes available (Of course SPPI says that Rolontis is not in competition w the biosims i.e. it will have its own J code, etc). In all likelihood there will be competition w Coherus BioSciences Neulasta biosim. The BSUFA action date for that one is June 9, 2017 but w the Novartis difficulties I will be looking at it more closely. After all, the biosim applications are similar in that they have to submit 3 pivotal clinical trials: one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies but Novartis couldn't show that it actually worked. Anyhows, a positive for SPPI in that there will be one less contestant (or more) when it’s Rolontis’ time for approval.