Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

The future playing field/market potential for Rolontis revisited. That CRL for Coherus' biosim for Neulasta sure was interesting! Well, it surprised me for sure. I thought it was a slam dunk but this pushes back their timeline a year. Couple that with Sandoz’s CRL for their biosim previously, and with Sandoz’s biosim they are not even giving a timeline, that leaves Mylan's biosimilar up next with a FDA decision due in October. I haven’t heard Coherus’ CC on the CRL but news outlets were reporting that the FDA had issues with a reanalysis of a subset of subject samples with a revised immunogenicity assay. Seems like the FDA is concerned with immunogenicity and you may be wondering what’s the big deal if it’s a similar to Pegfilgrastim and patients have been dosed a zillion times with that. I was thinking the same way but it made me (vaguely) recall that there were several versions of erythropoietin when it 1st came out; Epoetin in the US made by Amgen, and Procrit in the EU, made by J&J. Patients in the EU started getting adverse events (I forgot what but probably immunogenic) whereas the US patients weren’t getting these AEs. So maybe that’s the sort of reason that the FDA is a stickler for more immunogenic info on what should’ve been equivalent products.

Anyhows, I mentioned several times that that may have been a concern for Rolontis but as expressed in post 1654

Regarding the Rolontis trial going from 580 to 400 is promising on several fronts. It always seemed like overkill to me to have 580 pts to test for what essentially is a basic laboratory blood parameter, ANC. This is confirmed in a way by the looking at the # of pts for the EU trial, 218. This is telling me you only need 218 pts to get SS for the trial. And more importantly, what this is telling me is that the FDA is comfortable w the safety profile of Rolontis since they are not expecting any AEs or immunogenicity issues with it and the power to detect such a problem is not helped by having 580 pts. Very big in a way, besides making the trial go quicker it removes an elephant in the room.