Regulation - Biosimilars

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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

New phase of MAb biosimilars opportunities in Japan

New phase of MAb biosimilars opportunities in Japan

21-01-2015

The launch of Remicade (infliximab, from Johnson & Johnson) biosimilar in December 2014 in the Japan…

BiosimilarserythropoietinGenericsJapanMarkets & MarketingRegulationRemicade

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

“Achievements and goals are endless in health care,” says head of Turkey’s AİFD

05-01-2015

Secretary general and chief operating officer of Turkey’s Association of Research-Based Pharmaceutical…

BiosimilarsHealthcarePharmaceuticalRegulationResearchTurkey

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

US generic trade group supports compromise legislation for biosimilars

US generic trade group supports compromise legislation for biosimilars

11-12-2014

The USA's Generic Pharmaceutical Association (GPhA) has agreed to support compromise automatic substitution…

BiosimilarsGenericsLegalRegulationUSA

EGA and EBG see EMA latest biosimilars guidance as “important step forward”

EGA and EBG see EMA latest biosimilars guidance as “important step forward”

04-11-2014

The European Generic medicines Association (EGA) and the European Biosimilars Group (EBG), a sector group…

BiosimilarsEuropeGenericsRegulation

New analysis of potential savings from Biosimilars in USA

New analysis of potential savings from Biosimilars in USA

04-11-2014

Introducing competing “biosimilar” versions of complex biologic drugs used to treat illnesses such…

Anti-Arthritics/RheumaticsBiosimilarsFinancialGenericsOncologyRegulationSandozUSA

EMA guidance on facilitating global development of biosimilars

EMA guidance on facilitating global development of biosimilars

30-10-2014

The European Medicines Agency has published its revised overarching guideline on biosimilars, or follow-on…

BiosimilarsBiotechnologyEuropeRegulation

Polish and European generics groups view opportunities for biosimilars

29-10-2014

The European Biosimilars Group – a sector group of the European Generic medicines Association, together…

BiosimilarsEastern EuropeGenericsMarkets & MarketingPolandPricingRegulation

Discussion launched about the future of biosimilars in Italy

Discussion launched about the future of biosimilars in Italy

23-10-2014

Results from a survey of 470 European physicians conducted by the Alliance for Safe Biologic Medicines…

BiosimilarBiosimilarsBiotechnologyItalyRegulation

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

06-10-2014

When treating patients, patient safety is crucial. Regardless of whether this concerns biological, biosimilar…

BiosimilarsBiotechnologyDenmarkPharmacologyRegulation

EuropaBio calls for EMA action on labeling of biosimilars

18-09-2014

EuropaBio has published a statement giving the perspective of the health care biotechnology industry…

BiosimilarsBiotechnologyEuropeRegulation

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

10-09-2014

The European Commission granted marketing authorization for US drug major Eli Lilly and family-owned…

AbasriaBasaglarBiosimilarsBoehringer IngelheimDiabetesEli LillyEuropeInsulinLantusPharmaceuticalRegulationSanofi

Green Cross Neulapeg biosimilar approved in South Korea

28-08-2014

South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing…

AmgenAsia-PacificBiosimilarsBiotechnologyGreen CrossNeulapegNeulastaOncologyRegulation

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

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