Mylan's Next Up For A Shot At Neulasta Biosimilar After Coherus CRL
FDA issued a complete response letter to Coherus' application for a biosimilar version of Amgen's Neulasta (pegfilgrastim), giving Amgen a reprieve, though Mylan has an application pending at the US agency.
You may also be interested in...
Biosimilars of Amgen's blockbuster Neulasta pose a competitive threat to long-acting GSF Rolontis, but the company has experience with group purchasing and notes that large oncology clinics will make more revenue by providing higher-priced products.
Public Company Edition: Kiniksa, Scholar Rock and Iterum launch the most recent US IPOs and at least five more drug developers join the queue. Also, Polyphor go public in Switzerland, Valeant and Ligand sell notes, and MyoKardia led recent follow-on offerings.
Lilly will save $500m annually starting in 2018 after $1.2bn in layoff-related costs to reinvest in new products. Also, Cytori halves its headcount; VC OrbiMed closed a $551m Asia fund; and Insmed capitalizes on positive data.