Regulation - Biosimilars

Filter

Current filters:

Biosimilars

Popular Filters

1 to 25 of 43 results

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The US Food and Drug Administration has announced the availability of a draft guidance for industry titled…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

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

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

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

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

European generics group welcomes WHA resolution on biotherapeutics products

04-06-2014

The European Generic Medicines Association (EGA) has welcomed the 67th World Health Assembly’s Resolution…

BiosimilarsGenericsGlobalRegulation

European and Japanese generics groups view opportunities on biosimilars

European and Japanese generics groups view opportunities on biosimilars

29-05-2014

The European Generic Medicines Association (EGA) participated in several meetings with Japanese government…

BiosimilarsEuropeGenericsJapanMarkets & MarketingRegulation

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

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

07-04-2014

Uptake of biosimilars in Europe has increased as a result of member states’ policies, according to…

BiosimilarsEuropeFilgrastimInterviewsMarkets & MarketingRegulationSandoz

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

EGA calls for removal of barriers to competition and free trade for generics

EGA calls for removal of barriers to competition and free trade for generics

19-03-2014

The European Union must remove barriers to competition and free trade by introducing common sense reforms…

BiosimilarsEuropeGenericsMarkets & MarketingPatentsRegulation

BIO urges Indiana Governor to sign Bill on interchangeable biologic medicines

27-02-2014

US trade group the Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF)…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

1 to 25 of 43 results

Back to top