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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

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

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

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

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

US health advocacy groups state case on biosimilars naming policy

04-02-2014

In advance of today's US Federal Trade Commission workshop on follow-on biologics, or biosimilars, health…

BiosimilarsGenericsNorth AmericaRegulationUSA

US generics lobby group, GPhA, sets out 2014 priorities

US generics lobby group, GPhA, sets out 2014 priorities

04-02-2014

The US trade group the Generic Pharmaceutical Association (GPhA) has identified its key priorities for…

BiosimilarsGenericsHealthcareNorth AmericaRegulationUSA

Proposed US legislation on biosimilars welcomed by BIO and WBBA

Proposed US legislation on biosimilars welcomed by BIO and WBBA

23-01-2014

The USA’s Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

Celltrion’s trastuzumab biosimilar, Herzuma, approved in South Korea

16-01-2014

South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar…

Asia-PacificBiosimilarsCellTrionGenericsHerceptinHerzumaOncologyRegulationRoche

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

09-01-2014

Health care giant Johnson & Johnson’s Janssen Pharmaceutical companies have submitted a Citizen Petition…

BiosimilarsGenericsJanssenJohnson & JohnsonNorth AmericaRegulationUSA

US FTC rescheduled workshop on state regulations and naming conventions set for February

31-12-2013

The US Federal Trade Commission announced its one-day public workshop on competition and follow-on biologics,…

BiosimilarsGenericsMarkets & MarketingNorth AmericaRegulationUSA

Rapid uptake of rheumatoid arthritis biosimilars expected in Brazil and Mexico

19-12-2013

Biosimilars will be quickly acquired and used in public health institutions in the treatment of patients…

Anti-Arthritics/RheumaticsBiosimilarsBrazilGenericsMarkets & MarketingRegulationSouth America

Brazil’s ANVISA and ProGenericos sign cooperation agreement

Brazil’s ANVISA and ProGenericos sign cooperation agreement

18-12-2013

Brazil's National Health Surveillance Agency, ANVISA has signed a memorandum of technical and operational…

BiosimilarsBrazilGenericsRegulationResearchSouth America

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

28-11-2013

The Superior Court of Justice in Brazil recently annulled marketing approval for a sub-standard biosimilar…

BiosimilarsDoxelibGenericsLegalLibra LaboratoryOncologyRegulationSanofiSouth AmericaTaxotere

Mylan-Biocon Herceptin biosimilar gets first Indian approval

Mylan-Biocon Herceptin biosimilar gets first Indian approval

26-11-2013

US generic major Mylan says that its partner, India-based biotechnology firm Biocon has received approval…

Asia-PacificBioconBiosimilarsGenericsHerceptinHertrazMylan LaboratoriesOncologyRegulationRoche

Teva updates on Lonquex and Granix launches

Teva updates on Lonquex and Granix launches

18-11-2013

Israel-based Teva Pharmaceutical Industries announced two significant additions to its global oncology…

balugrastimBiosimilarsEuropeGenericsLonquexMarkets & MarketingNorth AmericaOncologyRegulationTeva Pharmaceutical Industries

European generic drugmakers call for maintenance of current robust WHO INN system

24-10-2013

The World Health Organization Consultation on International Non-proprietary Names (INN), open session…

BiosimilarsEuropeGenericsRegulation

EGA views future for generics and biosimilars in Europe

EGA views future for generics and biosimilars in Europe

14-10-2013

The European Generic medicines Association (EGA) recently launched its industrial policy vision for the…

BiosimilarsEuropeGenericsMarkets & MarketingRegulation

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