Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Looks like Mylan’s Neulasta biosimilar may be delayed. 1st it was Sandoz's biosim than Coherus' and now it looks like (nothing official yet) Mylan might get a CRL delaying a decision by the FDA by 3 months at least. Mylan’s Herceptin biosim is manufactured by its partner Biocon in Bangalore India. Turns out Mylan's Neulasta biosimilar is manufactured there also. After the FDA went to the plant, it got a 483 with 10 observations w numerous sub-parts. That's why I say at least 3 months. The EMA said that they need to inspect the plant before any approval. Their Neulasta biosim BDUFA date is in mid-October. Me thinks the Neulasta biosim will also be delayed.