Biosimilar

Results: 639



#Item
631Anatomy / Arthritis / Autoimmune diseases / Immunosuppressants / Connective tissue diseases / Etanercept / Cipla / Rheumatoid arthritis / Psoriatic arthritis / Health / Medicine / Rheumatology

Press Release - Launch of first biosimilar of Etanercept in India

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Source URL: www.cipla.com

Language: English - Date: 2013-04-17 00:51:46
632Pharmaceuticals policy / Food and Drug Administration / Pharmaceutical industry / Biosimilar / Drugs / Biologic / Generic drug / Test data exclusivity / Clinical trial / Pharmaceutical sciences / Pharmacology / Clinical research

Update 2008, Issue 3 With Permission from FDLI, www.fdli.org

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Source URL: www.torys.com

Language: English - Date: 2008-05-27 09:35:35
633Clinical research / European Medicines Agency / Pharmaceutical industry / Biosimilar / Summary of Product Characteristics / Medicinal product / Committee for Medicinal Products for Human Use / Pharmacology / Pharmaceutical sciences / Research

QRD guidance for generic-hybrid-biosimilar SmPC

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Source URL: www.ema.europa.eu

Language: English - Date: 2013-07-21 06:31:42
634Medicine / Biologic / Biotechnology / Committee for Medicinal Products for Human Use / Granulocyte colony-stimulating factor / Insulin / Biosimilar / Biology / Pharmacology / Peptide hormones

EMEA 法規(quideline on comparability of

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Source URL: www.cde.org.tw

Language: English - Date: 2011-01-02 21:58:51
635Pharmaceutical 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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Source URL: www.ipapharma.org

Language: English - Date: 2012-05-22 07:37:23
636Pharmaceuticals policy / Biosimilar / Biotechnology / Drugs / Generic drug / Food and Drug Administration / Test data exclusivity / Evergreening / Biologic / Pharmaceutical sciences / Pharmacology / Clinical research

PDF Document

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Source URL: www.healthlawyers.org

Language: English - Date: 2009-10-14 12:19:27
637Pharmaceutical sciences / Biosimilar / New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Prescription Drug User Fee Act / Biologic License Application / Biologic / Drug Price Competition and Patent Term Restoration Act / Center for Food Safety and Applied Nutrition / Food and Drug Administration / Medicine / Health

PDF Document

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Source URL: www.gpo.gov

Language: English - Date: 2013-05-23 12:15:25
638Clinical research / Drugs / Biosimilar / Pharmaceutical industry in India / Biopharmaceutical / Biologic / Strategic management / Kiran Mazumdar-Shaw / Biotechnology / Pharmacology / Pharmaceutical sciences

PDF Document

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Source URL: www.biocon.com

Language: English - Date: 2010-06-28 10:21:44
639Pharmaceutical industry / Patent law / Law / Intellectual property law / Test data exclusivity / Supplementary protection certificate / Biosimilar / Generic drug / European Medicines Agency / Pharmaceutical sciences / Pharmacology / Pharmaceuticals policy

PDF Document

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Source URL: ec.europa.eu

Language: English - Date: 2010-10-13 11:07:56
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