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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

Hospira’s Retacrit effective in chemotherapy-induced anemia

Hospira’s Retacrit effective in chemotherapy-induced anemia

24-07-2014

USA-based Hospira, a leading provider of generic injectable drugs and infusion technologies, announced…

BiosimilarsErythropoiesis-stimulating agentsGenericsHematologyHospiraInfusion technologiesResearchRetacritUSA

Cipla links with Hetero for biosimilar Aranesp; M&A in Yemen

30-06-2014

Cipla has collaborated with fellow Indian drugmaker Hetero to launch a biosimilar of the drug darbepoetin…

ActoriseAmgenAranespBiosimilarsCiplaGenericsHeteroIndiaMarkets & MarketingMergers & AcquisitionsOncologyRest of the World

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

Russian PM visits country's first commercial manufacturing plant for MAb-based therapeutic proteins

20-05-2014

Russian Prime Minister Dmitri Medvedev on Monday visited the commercial manufacturing facility for monoclonal…

BiocadBiosimilarsGenericsOncologyProductionRussia

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 president seeks partnership with Italian government on generics and biosimilars

09-04-2014

The president of the European Generic Medicines Association (EGA), Nick Haggar, attended the Stati Generali…

BiosimilarsEuropeGenericsItalyMarkets & MarketingPolitics

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

Teva UK launches Lonquex, a new long-acting G-CSF competitor to Amgen drugs

Teva UK launches Lonquex, a new long-acting G-CSF competitor to Amgen drugs

26-02-2014

The local subsidiary of Israeli generics giant Teva Pharmaceutical Industries has launched Lonquex (lipegfilgrastim)…

AmgenBiosimilarsGenericsLonquexMarkets & MarketingNorthern EuropeOncologyTeva Pharmaceutical IndustriesUK

Cadila net profit up by 82% in third-quarter

07-02-2014

Indian drugmaker Cadila Healthcare posted a net profit of 1.86 billion rupees ($29.7 million), for the…

BiosimilarsCadila PharmaceuticalsFinancialGenericsResearchZydus Cadila

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

Mylan debuts Hertraz, first Herceptin biosimilar, in India

Mylan debuts Hertraz, first Herceptin biosimilar, in India

03-02-2014

US generics major Mylan has launched the world's first trastuzumab biosimilar in India. The product,…

Asia-PacificBioconBiosimilarsGenericsHerceptinHertrazIndiaMarkets & MarketingMylan LaboratoriesOncologyRoche

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

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

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