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Brazil initiates public consultation on interchangeability of biosimilar drugs

Brazil initiates public consultation on interchangeability of biosimilar drugs

17-01-2014

Biosimilar drugs, also known as follow-on biologics, may soon be substituted in place of the reference…

BiosimilarsBrazilPharmaceuticalRegulationSouth America

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

Promising late-stage GI drugs could stabilize global market decline; report

16-01-2014

The gastrointestinal (GI) therapeutics market for irritable bowel syndrome (IBS), ulcerative colitis…

BiosimilarsGastro-intestinalsGlobalMarkets & MarketingPharmaceuticalRemicadeTakeda Pharmaceuticalsvedolizumab

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

Ranbaxy and EPIRUS sign licensing agreement for Infliximab biosimilar

Ranbaxy and EPIRUS sign licensing agreement for Infliximab biosimilar

09-01-2014

India's largest drugmaker Ranbaxy Laboratories (BSE: 500359) and EPIRUS Switzerland, a wholly-owned subsidiary…

Anti-Arthritics/RheumaticsBiosimilarsEPIRUS BiopharmaceuticalsGastro-intestinalsIndiainfliximabLicensingRanbaxy LaboratoriesRemicade

Walvax Biotech to take 64% stake in Genor BioPharma for around $49 million

Walvax Biotech to take 64% stake in Genor BioPharma for around $49 million

31-12-2013

China’s Walvax Biotech has revealed it plans to acquire a controlling 64% equity stake in Shanghai’s…

Asia-PacificBiosimilarsBiotechnologyChinaMergers & AcquisitionsOncology

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

Sandoz launches Phase III trial of biosimilars of AbbVie’s Humira

Sandoz launches Phase III trial of biosimilars of AbbVie’s Humira

19-12-2013

Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX), has initiated a Phase III clinical…

AbbVieBiosimilarsHumiraImmunologicalsNorthern EuropeResearchSandoz

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

Biogen Idec and Samsung Bioepis to market anti-TNF biosimilars in Europe

Biogen Idec and Samsung Bioepis to market anti-TNF biosimilars in Europe

17-12-2013

US biotech major Biogen Idec has exercised its right to enter into an agreement to commercialize anti-TNF…

Anti-Arthritics/RheumaticsBiogen IdecBiosimilarsBiotechnologyEuropeMarkets & MarketingSamsung Bioepis

Lack of familiarity with biosimilars among South Korean oncologists

Lack of familiarity with biosimilars among South Korean oncologists

16-12-2013

South Korean oncologists are significantly less familiar with biosimilars than oncologists surveyed in…

Asia-PacificBiosimilarsChinaGenericsOncology

Alvotech invests $250 million in biopharmaceuticals

08-12-2013

Alvotech, an independent sister company of Privately-held US generics firm Alvogen, a new player in the…

AlvogenAlvotechBiosimilarsEuropeFinancialProduction

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

Avesthagen in deal with Elpen for biosimilar Aranesp in parts of Europe

21-11-2013

Avesthagen Pharma AG, a unit of India’s Avesthagen Ltd, has signed an agreement with Greek life sciences…

AmgenAranespAvdespAvesthagenBiosimilarsElpen PharmaceuticalsEuropeMarkets & MarketingNephrology and Hepatology

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

Pennsylvania legislation calls for patient and physician notification on biological substitution

Pennsylvania legislation calls for patient and physician notification on biological substitution

14-11-2013

The US state of Pennsylvania’s Senate Public Health and Welfare Committee has approved Senate Bill…

BiosimilarsBiotechnologyLegalNorth AmericaRegulation

Formycon set to exploit biosimilars opportunities, says analyst

08-11-2013

Germany-based Formycon AG is preparing to exploit the emerging opportunity for biosimilars, according…

BiosimilarsFinancialFormyconMarkets & Marketing

Call for rapid adoption of EU biosimilars guideline

01-11-2013

The European Generic medicines Association says it congratulates the European Medicines Agency and its…

BiosimilarsEuropeRegulation

Stada Arz expands biosimilars range, in-licensing Grastofil from Apotex

Stada Arz expands biosimilars range, in-licensing Grastofil from Apotex

30-10-2013

German generic and branded drugmaker Stada Arzneimittel says it has strengthened its activities in the…

AmgenApotexBiosimilarsEuropeGrastofilHematologyLicensingNeupogenSTADA Arzneimittel

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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