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Pharmaceutical industry / Food and Drug Administration / Pharmaceuticals policy / Biosimilar / Intas Biopharmaceuticals / Biologic / Hospira / Clinical trial / Reliance Life Sciences / Pharmaceutical sciences / Pharmacology / Clinical research


Article Current regulations governing biosimilars
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Document Date: 2012-05-22 07:37:23

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City

Mumbai / Geneva / /

Company

Filgrastim Hexal 9 Neupogen Ratiograstim Filgrastim Ratiopharm GmbH / Novartis / Elmach Packages (India) Pvt. Ltd. / Universal Medicap Ltd. / Reliance Life Sciences Pvt. Ltd / UBM India Pvt Ltd. / Sciences 2 Darbepoietin Dr Reddy’s Labs / No. Name Company / IMS Health / Gennova Biopharmaceuticals Ltd / Medice Arzneimittel Putter Gmbh / Accin Packaging Pvt. Ltd. / Hexal AG / Hospira Inc. / Sanira Associates / Novo Nordisk / NKP Pharma / To References 1 / Fabtech Technologies International Ltd. / BioPartners GmbH / EMEA / Precitech Industries / Neupogen Nivestim Teva Generics GmbH / Brothers Pharmamach (India) Pvt. Ltd. / Neupogen Biograstim CT Arzneimittel GmbH / Baxter / Accupack Engineering Pvt. Ltd. / Life Sciences Biocon Dr Reddy’s Labs / India (GoI) Gazette / Halozyme Therapeutics / TSA Process Equipment Pvt. Ltd. / Biopharmaceuticals 11 Rituximab Dr Reddy’s Labs / Intas Biopharmaceuticals Virchow Biotech Pvt. Ltd / Stada Arzneimittel AG / No. Trade Name Descriptive Name Company / Newtronic Equipment Company Pvt. Ltd. / Ami Polymer Pvt. Ltd. / A.P. State Private Pharmacy / /

Continent

Europe / /

Country

Venezuela / South Africa / Japan / Brazil / Canada / Australia / Korea / India / Taiwan / Saudi Arabia / Sri Lanka / Turkey / Malaysia / United States / Singapore / Argentina / /

Currency

USD / /

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Event

FDA Phase / /

Facility

Colambia Institute of Pharmacy / Pharmacy Institutions / Biocon Intas Biopharmaceuticals Reliance Life Sciences Shantha Biotech Serum Institute of India Wockhardt India / Peter’s Institute of Pharmaceutical Sciences / /

IndustryTerm

plasma products / pharmaceutical lobby / similar biologics product / abbreviated biosimilar biologics license applications / drug product / reference innovator product / allergenic product / proposed biological product / biotherapeutic products / biosimilar biological product / product / proposed biosimilar product / manufacturing process / final product / pharmaceuticals / reference protein product / similar biotherapeutic products / test site / analogous product / licensed reference biotherapeutic product / biopharmaceutical approvals / biosimilar products / manufacturing / follow-on protein products / similar biologic product / similar biological medicinal products / subsequent biological product / licensed originator product / biological products / innovator recombinant product / biotechnology / physico-chemical and biological characterization / comparator product / reference product / biological medicinal product / defined study protocols / recombinant human soluble insulin products / biological product / innovator biopharmaceutical products / biopharmaceutical / reference biologic product / biotechnology-derived proteins / Manufacturing permission / proposed interchangeable product / biosimilar product / biosimilars/similar biologics products / biotechnological medicinal products / stand-alone product / similar biologics products / /

MedicalCondition

chronic administration / diseases / disease / /

MedicalTreatment

antibiotics / /

Organization

World Health Organization / New Drug Advisory Committee / Dhirubhai Ambani Life Sciences Centre / AP / Indian Pharmaceutical Association / U.S. Congress / Department of Biotechnology / Indian government / Biocon Intas Biopharmaceuticals Reliance Life Sciences Shantha Biotech Serum Institute / Biotechnology Regulatory Authority of India / Indian Parliament / European Union / Government of India / Genetic Engineering Approval Committee / Colambia Institute of Pharmacy / Ministry of Health and Family Welfare / Institute of Pharmacy / Associated Press / St. Peter’s Institute of Pharmaceutical Sciences / Central Drugs Standard Control Organization / European Medicines Agency / Ministry of Science and Technology / US Food and Drug Administration / Committee on Genetic Manipulation / National Biotechnology Regulatory Authority / Department of Environment / R&D Institutional Biosafety Committee / Institutional Animal Ethics Committee / /

Person

T. Jayapal Reddy / Bobby George / /

Position

interest /

Product

Neupogen / Glucagon / Chorionic gonadotropin / Omnitrope / GlucaGen / Humatrope / Valtropin / Eprex / Genotropin / India / RBP9 / /

ProvinceOrState

Andhra Pradesh / Connecticut / /

PublishedMedium

the NDAC review / /

Technology

Genetic Engineering / defined study protocols / recombinant DNA / alpha / antibodies / biotechnology / P2P / /

URL

www.rellife.com / /

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