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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

Brazil’s Cristalia gains ANVISA approval for production of biosimilar drugs

24-03-2014

The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBrazilCristaliaEnbrelHerceptinMetabolicsNorditropinOncologyProductionRegulationSouth America

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

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

10-02-2014

Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan…

Asia-PacificBioconBiosimilarsCanmabHerceptinHertrazIndiaLegalMylan LaboratoriesOncologyPatentsPharmaceuticalRegulationRoche

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

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

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

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