Nora Pharma, a Canadian pharmaceutical company, has received approval for its first biosimilar product. Nora Pharma, a wholly owned division of Sunshine Biopharma, has received approval from Health Canada for the commercialization of Niopeg (a pegylated form of filgrastim) in Canada.
Apotex Inc.,announced that, as of February 13th, 2015, the FDA has accepted for filing the company's application for Filgrastim [Grastofil],...
Sandoz, a Novartis company, announced that the FDA approved Zarxio (filgrastim-sndz) (Zarzio in EU) for all indications included in the...
Sandoz, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's...
BioLineRx Ltd. a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, announced that the FDA has approved Aphexda (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma
Adello Biologics announced that FDA has accepted for review the company’s Biologics License Application (BLA) for a biosimilar candidate (TPI-G-CSF)...
Sandoz, a Novartis company, announced that Zarxio (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar...
The US Court of Appeal for the Federal Circuit has ruled that Sandoz must wait 180 days from FDA approval...