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Biosimilar
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161	Engineering Next-Generation Therapeutic Proteins: Trends and Markets toExecutive Summary Executive Summary Add to Reading List Source URL: www.insightpharmareports.com Language: English - Date: 2011-08-03 14:46:23 Pharmacology Immune system Immunology Monoclonal antibodies Fusion protein Biologic Polyclonal antibodies Biosimilar Humanized antibody Pharmaceutical sciences Biology Biotechnology
162	Page 1 FDA Media Briefing First Biosimilar Approval in the United States March 6, [removed]:00 am ET Add to Reading List Source URL: www.fda.gov Language: English Biosimilar Biotechnology Drugs Biologic Food and Drug Administration Pharmacology Clinical research Pharmaceutical sciences
163	Public Consultation on Authority Required Medicines for the Post-market Review of Authority Required PBS Listings Dr Brett Robinson, Managing Director & CEO Icon Cancer Care Add to Reading List Source URL: www.pbs.gov.au Language: English - Date: 2015-03-04 00:10:33 Biotechnology Drugs Alternative medicine Patient safety Bevacizumab Medicine Health Biosimilar
164	Microsoft Word - 16618dft.doc Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Center for Biologics Evaluation and Research Biosimilar FDA Special Protocol Assessment New Drug Application Generic drug Center for Drug Evaluation and Research Biologic Food and Drug Administration Pharmaceutical sciences Medicine
165	Proposals for extending data protection for biologics in the TPPA: Potential consequences for Australia Submission to the Department of Foreign Affairs and Trade 15 December 2014 Add to Reading List Source URL: www.dfat.gov.au Language: English - Date: 2015-03-19 00:53:46 Medicine Biosimilar Biologic Pharmaceutical industry Food and Drug Administration Test data exclusivity Pharmaceutical Benefits Scheme Pharmaceutical policy Etanercept Pharmaceutical sciences Pharmacology Pharmaceuticals policy
166	Consumer Health Information www.fda.gov/consumer Biosimilars: More Treatment Options Are on the Way Add to Reading List Source URL: www.fda.gov Language: English Biotechnology Drugs Biosimilar Biologic Pharmaceuticals policy Pharmaceutical industry Food and Drug Administration Generic drug Hospira Pharmaceutical sciences Pharmacology Clinical research
167	Mixing , Diluting, or Repackaging Biological Products Outside the Scope of An Approved Biologics License Application Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Biologic License Application Center for Biologics Evaluation and Research Biologic Federal Food Drug and Cosmetic Act Center for Drug Evaluation and Research Abbreviated New Drug Application Good manufacturing practice Biosimilar Food and Drug Administration Medicine Health
168	Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Oncologic Drugs Advisory Committee Meeting January 7, 2015 Location: FDA White Oak Campus, Building 31, the Great Room, White Oa Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Amgen Filgrastim Hematology Center for Drug Evaluation and Research Hospira Biosimilar Neutropenia Febrile neutropenia Medicine Health Pharmacology
169	50 YEARS EU PHARMACEUTICAL REGULATION MILESTONES LEGISLATIVE 60s Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2015-02-04 09:06:30 Pharmacology Clinical research Pharmaceutical industry Pharmaceuticals policy European Medicines Agency Pharmacovigilance Biosimilar Biologic Adverse effect Pharmaceutical sciences Health Medicine
170	Sandoz International GmbH Industriestr[removed]Holzkirchen Germany Website: www.sandoz.com a Novartis company Add to Reading List Source URL: www.sandoz.com Language: English - Date: 2014-08-26 10:16:54 Pharmaceutical industry Novartis Biosimilar Sandoz Generic drug Sandoz watches Pharmaceutical sciences Pharmacology Pharmaceuticals policy

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