Neulasta
Sandoz scores FDA approval for Neulasta biosimilar Ziextenzo to treat febrile neutropenia infection
November 6, 2019Research and Development, Sales and Marketing Amgen, FDA, Neulasta, Sandoz, Ziextenzo, pharma
The FDA has authorised the availability of Sandoz’s Ziextenzo (pegfilgrastim-bmez), a biosimilar version of Amgen’s Neulasta, it has emerged. The …
Pegfilgrastim greenlight marks eighth biosimilar approval in Europe for Sandoz
November 27, 2018Manufacturing and Production, Sales and Marketing Amgen, Neulasta, Sanofi, Ziextenzo, biosimilars, pegfilgrastim, pharma
The European Commission has chosen to grant marketing authorisation to Ziextenzo, Sandoz’s biosimilar version of pegfilgrastim, better known as Amgen’s …
Mundipharma’s Neulasta biosimilar approved in EU
November 26, 2018Sales and Marketing Amgen, EU, Europe, Mundipharma, Neulasta, Pelmeg, pharma
Mundipharma has revealed that Pelmeg, its biosimilar version of Amgen’s Neulasta (pegfilgrastim), has been awarded marketing approval by the European …
CHMP recommend white blood cell growth stimulator biosimilar to EMA
July 30, 2018Sales and Marketing Amgen, CHMP, EMA, Neulasta, biosimilar, chemotherapy, pegfilgrastim
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of two separate …
Mylan lands biosimilar sucker punch to Amgen’s blockbuster
June 6, 2018Research and Development, Sales and Marketing Amgen, Biocon, Mylan, Neulasta
Mylan and Biocon have received FDA approval for their biosimilar to Amgen’s Neulasta (pegfilgrastim), setting the companies on track to …
Mylan and Biocon Neulasta biosimilar knocked back by FDA
October 11, 2017Research and Development, Sales and Marketing Amgen, Biocon, Mylan, Neulasta, biotech, drugs, pharma, pharmaceutical
Mylan and Biocon’s biosimilar version of Amgen’s blockbuster, Neulasta (pegfilgrastim), will have to wait a bit longer before getting the …
Amgen accuses biosimilar producer of ‘massive conspiracy’
March 9, 2017Medical Communications Amgen, Coherus, Neulasta, biosimilars
Amgen has filed a lawsuit in a Californian state court against Coherus Biosciences, suggesting that Coherus had stolen trade secrets. …
Biosimilars: Can the US catch up in 2016?
February 12, 2016Medical Communications, Sales and Marketing Eli Lilly, Enbrel, FDA, Neulasta, Novartis, Pfizer, Sandoz, Zarxio, biosimilars
What are biosimilars? Biosimilars are essentially the biological equivalent of generic drugs to their branded small-molecule counterparts (what Ibuprofen is …
EMA accepts Sandoz Neulasta biosimilar for review
February 11, 2016Research and Development Amgen, Neulasta, Novartis, Sandoz
Sandoz says the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for its proposed biosimilar to Amgen’s …
Sandoz announces biosimilar successes
December 8, 2015Manufacturing and Production American Society of Hematology, Enbrel, Neulasta, Sandoz, ash, biosimilars, etanercept, pegfilgrastim
Novartis’ biosimilars division Sandoz has announced progress in its biosimilars programme, with its version of Amgen’s Neulasta proving as effective …
FDA accepts regulatory submission for Novartis biosimilar
November 18, 2015Research and Development, Sales and Marketing Neulasta, Novartis, Sandoz, biosimilar, pegfilgrastim
Novartis’ generics unit Sandoz has announced it has had its Biologics License Application (BLA) for a proposed biosimilar to Amgen’s …
Novartis starts late-stage biosimilar trials for Amgen drugs
January 19, 2012Research and Development, Sales and Marketing Amgen, Neulasta, Neupogen, Novartis
Novartis has begun Phase III biosimilar trials to copycat two of Amgen’s neutropenia drugs. The studies, which are being undertaken …
