Regulation - Biosimilars, Oncology

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Sandoz application for biosimilar Neupogen accepted by US FDA

25-07-2014

The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarzio

Biocad’s AcellBia is first MAb biosimilar approved by Russia’s Ministry of Health

15-05-2014

A biosimilar of Swiss drug major Roche’s MabThera (rituximab), to be marketed under the trade name…

AcellBiaBiocadBiosimilarsGenericsMabTheraOncologyRegulationRocheRussia

Roche may lose $240 million contract in Russia to Biocad biosimilar

Roche may lose $240 million contract in Russia to Biocad biosimilar

07-05-2014

Swiss drug major Roche may lose an important $240 million contract in Russia for the supply of its anti-cancer…

AcellBiaBiocadBiosimilarsBiotechnologyMabTheraMarkets & MarketingOncologyRegulationrituximabRoche

Brazil’s Cristalia gains ANVISA approval for production of biosimilar drugs

24-03-2014

The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBrazilCristaliaEnbrelHerceptinMetabolicsNorditropinOncologyProductionRegulationSouth America

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

10-02-2014

Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan…

Asia-PacificBioconBiosimilarsCanmabHerceptinHertrazIndiaLegalMylan LaboratoriesOncologyPatentsPharmaceuticalRegulationRoche

Celltrion’s trastuzumab biosimilar, Herzuma, approved in South Korea

16-01-2014

South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar…

Asia-PacificBiosimilarsCellTrionGenericsHerceptinHerzumaOncologyRegulationRoche

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

28-11-2013

The Superior Court of Justice in Brazil recently annulled marketing approval for a sub-standard biosimilar…

BiosimilarsDoxelibGenericsLegalLibra LaboratoryOncologyRegulationSanofiSouth AmericaTaxotere

Mylan-Biocon Herceptin biosimilar gets first Indian approval

Mylan-Biocon Herceptin biosimilar gets first Indian approval

26-11-2013

US generic major Mylan says that its partner, India-based biotechnology firm Biocon has received approval…

Asia-PacificBioconBiosimilarsGenericsHerceptinHertrazMylan LaboratoriesOncologyRegulationRoche

Teva updates on Lonquex and Granix launches

Teva updates on Lonquex and Granix launches

18-11-2013

Israel-based Teva Pharmaceutical Industries announced two significant additions to its global oncology…

balugrastimBiosimilarsEuropeGenericsLonquexMarkets & MarketingNorth AmericaOncologyRegulationTeva Pharmaceutical Industries

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