Showing 12 posts of 12 posts found.


Sandoz scores FDA approval for Neulasta biosimilar Ziextenzo to treat febrile neutropenia infection

November 6, 2019
Research 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, 2018
Manufacturing 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, 2018
Sales 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 …

White blood cells

CHMP recommend white blood cell growth stimulator biosimilar to EMA

July 30, 2018
Sales 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, 2018
Research 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, 2017
Research 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, 2017
Medical 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, 2016
Medical 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, 2016
Research 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 …

EMA inside

Sandoz announces biosimilar successes

December 8, 2015
Manufacturing 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 sign

FDA accepts regulatory submission for Novartis biosimilar

November 18, 2015
Research 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, 2012
Research 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 …

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