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Celltrion files for US FDA approval of Remsima biosimilar

Celltrion files for US FDA approval of Remsima biosimilar

13-08-2014

South Korean biopharmaceutical firm Celltrion says it has completed the filing procedure to obtain US…

BiosimilarsBiotechnologyCellTrionClinical researchInflammatory diseasesinfliximabJanssen BiotechJohnson & JohnsonPatentsRegulationRemicadeRemsimaUSA

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The US Food and Drug Administration has announced the availability of a draft guidance for industry titled…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

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

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

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

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

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