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FDA issues new biosimilars guidance on exclusivity

FDA issues new biosimilars guidance on exclusivity

11-08-2014

The US Food and Drug Administration has announced the availability of a draft guidance for industry titled…

BiosimilarsBiotechnologyFinancialRegulationUSA

Harlan aims to provide expertise for biologics and biosimilars

31-07-2014

Switzerland-based Harlan Laboratories, a privately held provider of general and specialty toxicology…

BiosimilarsBiotechnologyContract research servicesHarlanRegulationResearchSwitzerlandToxicology services

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

Strides Arcolab makes strategic investment in Oncobiologics

Strides Arcolab makes strategic investment in Oncobiologics

16-07-2014

India’s Strides Arcolab has made a series of strategic investments in Oncobiologics, a privately held…

BiosimilarsBiotechnologyFinancialIndiaMergers & AcquisitionsOncobiologicsStrides Arcolab

Brazil’s Bionovis, BNDES and Fiocruz sign an investment agreement

Brazil’s Bionovis, BNDES and Fiocruz sign an investment agreement

07-07-2014

This month, the government of Brazil’s State of Rio de Janeiro, the Brazilian Development Bank (BNDES),…

BionovisBiosimilarsBiotechnologyBrazilFinancialFiocruzProductionResearch

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

02-07-2014

A total of 32 organizations have signed a letter calling on the US Food and Drug Administration to require…

BiosimilarsBiotechnologyRegulationUSA

JHL Biotech’s new $35 million financing will fund biosimilars

JHL Biotech’s new $35 million financing will fund biosimilars

22-06-2014

Taiwan biopharma company JHL Biotech say it has closed a Series B financing round of $35 million, led…

Asia-PacificBiosimilarsBiotechnologyFinancialJHL BiotechProductionResearch

EULAR: Ph III data demonstrate comparability of Epirus' BOW015 to Remicade for RA

EULAR: Ph III data demonstrate comparability of Epirus' BOW015 to Remicade for RA

12-06-2014

USA-based privately-held Epirus Biopharmaceuticals, focused on the development and commercialization…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBOW015EPIRUS BiopharmaceuticalsinfliximabRemicadeResearch

Lucrative biosimilars space to erode biologics market from 2019

Lucrative biosimilars space to erode biologics market from 2019

11-06-2014

The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market…

BiosimilarsBiotechnologyGlobalMarkets & MarketingRegulation

India encouraging opportunities for biotech innovation

India encouraging opportunities for biotech innovation

27-05-2014

In a bid to encourage new and innovative ideas for research and commercialization, the Indian government's…

BiosimilarsBiotechnologyFinancialIndiaResearch

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

Lupin inks strategic biosimilars joint venture agreement with Yoshindo

23-04-2014

Indian drugmaker Lupin has entered into a strategic joint venture agreement with Japanese pharma company,…

BiosimilarsBiotechnologyEnbrelInflammatory diseasesJapanLicensingLupinTakeda PharmaceuticalYoshindo

Epirus to acquire Zalicus, creating a publicly-traded biosimilars enterprise

16-04-2014

Boston-based privately-held Epirus Biopharmaceuticals, focused on the global development and commercialization…

BiosimilarsBiotechnologyEPIRUS BiopharmaceuticalsMergers & AcquisitionsZalicus

Fast growth forecast for South Korean pharma market

Fast growth forecast for South Korean pharma market

02-04-2014

South Korea's pharmaceuticals market was valued at $20 billion in 2012, growing from $14.5 billion in…

Asia-PacificBiosimilarsBiotechnologyMarkets & MarketingPricingResearch

Pan-European survey calls for a shift in policy for biosimilars

Pan-European survey calls for a shift in policy for biosimilars

19-03-2014

This week, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European…

BiosimilarsBiotechnologyEuropeHealthcareRegulation

Merck names Simon Sturge as new head of biosimilars unit

Merck names Simon Sturge as new head of biosimilars unit

20-02-2014

Germany’s Merck KGaA has appointed Simon Sturge to head the biosimilars unit, effective March 1, succeeding…

BiosimilarsBiotechnologyBoardroomManagementMerck KGaA

Kissei collaborates with Alteogen on biosimilars

14-02-2014

Japanese drugmaker Kissei Pharmaceutical has entered into a business collaboration agreement with South…

BiosimilarsBiotechnologyKissei PharmaceuticalResearch

Walvax Biotech to take 64% stake in Genor BioPharma for around $49 million

Walvax Biotech to take 64% stake in Genor BioPharma for around $49 million

31-12-2013

China’s Walvax Biotech has revealed it plans to acquire a controlling 64% equity stake in Shanghai’s…

Asia-PacificBiosimilarsBiotechnologyChinaMergers & AcquisitionsOncology

Biogen Idec and Samsung Bioepis to market anti-TNF biosimilars in Europe

Biogen Idec and Samsung Bioepis to market anti-TNF biosimilars in Europe

17-12-2013

US biotech major Biogen Idec has exercised its right to enter into an agreement to commercialize anti-TNF…

Anti-Arthritics/RheumaticsBiogen IdecBiosimilarsBiotechnologyEuropeMarkets & MarketingSamsung Bioepis

Pennsylvania legislation calls for patient and physician notification on biological substitution

Pennsylvania legislation calls for patient and physician notification on biological substitution

14-11-2013

The US state of Pennsylvania’s Senate Public Health and Welfare Committee has approved Senate Bill…

BiosimilarsBiotechnologyLegalNorth AmericaRegulation

California Governor rejects Biosimilars Bill

14-10-2013

The Governor of the US state of California, Jerry Brown, on Saturday (October 11) vetoed proposed legislation…

BiosimilarsBiotechnologyLegalNorth AmericaRegulation

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