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Farmaindustria defends the non-interchangeability principle for biologic and biosimilar medicines

21-03-2015

Speaking at the first Biological Medicines Forum organized by the Associations last week, the president…

BiosimilarsBiotechnologyPatents & Trade marksRegulationSpain

Spain to reduce the prices of new biosimilars by up to 30%

Spain to reduce the prices of new biosimilars by up to 30%

12-03-2015

After months of uncertainty, the Spanish Ministry of Health has announced its new policy for the biosimilars…

BiosimilarsBiotechnologyinfliximabPoliticsPricingSpain

Prime Therapeutics welcomes FDA's approval of first biosimilar in USA, but says more clarity is needed

Prime Therapeutics welcomes FDA's approval of first biosimilar in USA, but says more clarity is needed

09-03-2015

Prime Therapeutics, a non-profit US pharmacy benefit manager serving more than 26 million members, has…

AmgenBiosimilarsBiotechnologyNeupogenNovartisOncologyRegulationSandozUSAZarxio

Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

06-03-2015

Sandoz, the generics unit of Swiss pharma giant Novartis, today received approval from the US Food and…

AmgenBiosimilarsBiotechnologyNeupogenNovartisOncologyRegulationSandozUSAZarxioZarzio

US biosimilar approvals poised to grow, but market uptake faces challenges, says Tufts CSDD

05-03-2015

Biosimilar approvals in the USA are expected to increase during the next five years, but safety concerns…

BiosimilarsBiotechnologyFinancialMarkets & MarketingRegulationUSA

Interview: Boehringer Ingelheim's Heidi Hunter on biosimilar originality, jousting and getting to market

Interview: Boehringer Ingelheim's Heidi Hunter on biosimilar originality, jousting and getting to market

02-03-2015

German family-owned drug major Boehringer Ingelheim has been in the biosimilars business since the end…

BiosimilarsBiotechnologyBoehringer IngelheimGermanyHeidi HunterInterviews

Intas becomes first Indian company to launch biosimilar in the EU

Intas becomes first Indian company to launch biosimilar in the EU

23-02-2015

Indian biopharma company Intas has become the first Indian company to launch a biosimilar in highly regulated…

BiosimilarsBiotechnologyFilgrastimHematologyImmunologicalsIndiaIntas PharmaceuticalsMarkets & MarketingRegulation

Russia’s Biocad to invest $120 million in expansion of domestic operations

23-02-2015

Biocad, one of Russia’s largest biotech companies, has officially announced its plans to invest up…

AvastinBiocadBiosimilarsBiotechnologyFinancialHerceptinOncologyProductionRocheRussia

Roche likely to lose another state contract in Russia

Roche likely to lose another state contract in Russia

23-02-2015

Swiss pharma giant Roche will probably lose one of its major contracts in Russia for the next several…

AvastinBiocadBiosimilarsBiotechnologyMarkets & MarketingOncologyRocheRussia

Hospira’s biosimilar Inflectra comparable to Remicade in IBD treatment

Hospira’s biosimilar Inflectra comparable to Remicade in IBD treatment

19-02-2015

Positive data have been presented today on the use of Hospira's Inflectra (infliximab), the world's first…

BiosimilarsBiotechnologyGastro-intestinalsHospiraInflectraJohnson & JohnsonMerck & CoRemicadeResearch

Pfenex soars on Lucentis biosimilar deal with Hospira

Pfenex soars on Lucentis biosimilar deal with Hospira

10-02-2015

Shares of US clinical-stage biotech firm Pfenex leapt 28% to $8.85 in morning trading, after the company…

BiosimilarsBiotechnologyGenentechGlobalHospiraLicensingLucentisNovartisOphthalmicsPF582PfenexResearchRoche

CMOs must offer meaningful value to take advantage of biosimilars trend, says report

30-01-2015

If contract manufacturing organizations are to take advantage of the wave of interest in biosimilars,…

BiosimilarsBiotechnologyComputer hardwareLicensingPharmSourceProduction

Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

21-01-2015

South Korea’s Samsung Bioepis says that the Marketing Authorization Application for its Enbrel (etanercept)…

AmgenAnti-Arthritics/RheumaticsBiogen IdecBiosimilarsBiotechnologyEnbrelEuropePfizerRegulationSamsung Bioepis

Naming conventions for biosimilars in Australia

Naming conventions for biosimilars in Australia

21-01-2015

Following recent international developments in the area of biosimilar naming, Australian regulator the…

AustraliaBiosimilarsBiotechnologyRegulationTherapeutic Goods Administration

Hospira submits new BLA for epoetin alfa biosimilar In USA

12-01-2015

US injectable drugs and infusion technologies and biosimilars developer Hospira has submitted a Biologics…

AmgenBiosimilarsBiotechnologyepoetinEpogenHematologyHospiraJanssenJohnson & JohnsonProcritRegulationRetacritUSA

BIO urges US FDA to release guidance on biosimilars

BIO urges US FDA to release guidance on biosimilars

08-01-2015

The US trade group the Biotechnology Industry Organization (BIO) has called on the Food and Drug Administration…

BiosimilarsBiotechnologyRegulationUSA

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

08-01-2015

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarxio

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

06-01-2015

In briefing papers ahead of an advisory committee meeting, agency staff at the US Food and Drug Administration…

AmgenBiosimilarsBiotechnologyImmunologicalsNeupogenNovartisRegulationUSA

US health care predictions from Steven Burrill

US health care predictions from Steven Burrill

24-12-2014

US politics will continue to be characterized by partisanship as the Republican majorities in the House…

BiosimilarsBiotechnologyHealthcarePoliticsRegulationUSA

Sandoz demonstrates safety and efficacy of Neupogen biosimilar

Sandoz demonstrates safety and efficacy of Neupogen biosimilar

08-12-2014

Sandoz, the generics subsidiary of Swiss pharma major Novartis, has today released Phase III data that…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyResearchSandoz

PHARMAC secures significant savings for New Zealand’s DHBs on biologic drug

04-12-2014

A new agreement for a high cost biologic drug will yield considerable savings for District Health Boards…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyinfliximabJohnson & JohnsonNew ZealandPricingRemicade

Spanish physicians’ understanding of biosimilars: ASBM survey

28-11-2014

The Alliance for Safe Biologic Medicines (ASMB) presented results from a survey of European physicians…

BiosimilarsBiotechnologyHealthcareMarkets & MarketingSpain

Stada Arz and mAbxience to negotiate over adalimumab biosimilar

21-11-2014

German drugmaker Stada Arzneimittel and the biotech specialist mAbxience have agreed to negotiate over…

AbbVieadalimumabAnti-Arthritics/RheumaticsBiosimilarsBiotechnologyHumiraLicensingMabxienceSTADA Arzneimittel

Micreos' Staphefekt is the world's first bacteria-killing enzyme for human use in MRSA

Micreos' Staphefekt is the world's first bacteria-killing enzyme for human use in MRSA

07-11-2014

The breakthrough achieved by Dutch bacterial specialist Micreos is the most promising development the…

Antibiotics and Infectious diseasesBiosimilarsBiotechnologyInterviewsMicreosNetherlandsResearchStaphefekt

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