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Amgen and Novartis applauded for support of investor principles in biosimilar industry

Amgen and Novartis applauded for support of investor principles in biosimilar industry

12-08-2014

A coalition of institutional investors who have over $430 billion in assets has commended Amgen and Novartis…

AmgenBiosimilarBiosimilarsFinancialNovartisSandozUSA

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The US Food and Drug Administration has announced the availability of a draft guidance for industry titled…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

US Senators call for immediate release of guidance on biosimilar drugs

US Senators call for immediate release of guidance on biosimilar drugs

06-08-2014

US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in…

BiosimilarsGenericsPoliticsRegulationUS Food and Drug AdministrationUSA

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

Hospira’s Retacrit effective in chemotherapy-induced anemia

Hospira’s Retacrit effective in chemotherapy-induced anemia

24-07-2014

USA-based Hospira, a leading provider of generic injectable drugs and infusion technologies, announced…

BiosimilarsErythropoiesis-stimulating agentsGenericsHematologyHospiraInfusion technologiesResearchRetacritUSA

Biosimilars market to hit $35 billion by 2020, research suggests

Biosimilars market to hit $35 billion by 2020, research suggests

22-07-2014

The global biosimilars market could reach $35 billion by 2020, rising from the $1.3 billion it was worth…

BiosimilarsResearch

ABPI and Bioindustry Association team up to improve biosimilar understanding

ABPI and Bioindustry Association team up to improve biosimilar understanding

21-07-2014

The Association of the British Pharmaceutical Industry (ABPI) and the Bioindustry Association (BIA) have…

Association of the British Pharmaceutical IndustryBiosimilarsRegulationUK

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

Study reveals factors supporting a sustainable European biosimilar medicines market

Study reveals factors supporting a sustainable European biosimilar medicines market

13-06-2014

Biosimilar medicines will deliver an opportunity for increased access to better healthcare for patients…

AvastinBiosimilarsEuropeHealthcareHerceptinHumiraRegulation

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

Generic and biosimilar drugs should be key components of CSRs for health, says EGA

Generic and biosimilar drugs should be key components of CSRs for health, says EGA

05-06-2014

The increased number of health related proposed country specific recommendations (CSR) to European Union…

BiosimilarsGenericsHealthcareRegulation

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