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101	Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.biosimilarslawblog.com Language: English - Date: 2014-10-07 15:07:44 Clinical research Pharmaceutical industry Food and Drug Administration Biotechnology Biosimilar Biologic Validation Pharmacokinetics New Drug Application Pharmaceutical sciences Pharmacology Medicine
102	Fritz Bittenbender Senior Vice President External Affairs │ BIOTECHNOLOGY INDUSTRY ORGANIZATION Add to Reading List Source URL: www.massbio.org Language: English - Date: 2013-11-01 14:07:16 Biosimilar Biotechnology Drugs Biologic Food and Drug Administration Pharmacology Clinical research Pharmaceutical sciences
103	PDF Document Add to Reading List Source URL: www.skgf.com Language: English - Date: 2015-03-19 11:25:48 Property law Biosimilar Declaratory judgment Term of patent United States patent law United States Patent and Trademark Office Patent Prior art Patent law Civil law Law
104	PDF Document Add to Reading List Source URL: www.fdalawblog.net Language: English - Date: 2015-04-24 07:45:40 Law United States patent law Amicus curiae Roman law Biosimilar
105	PDF Document Add to Reading List Source URL: www.bcgperspectives.com Language: English - Date: 2014-12-10 15:30:29 Pharmacology Pharmaceutics Generic drug Public domain Ratiopharm Biosimilar Abbreviated New Drug Application Generic brand Authorized generics Pharmaceutical industry Pharmaceutical sciences Pharmaceuticals policy
106	PDF Document Add to Reading List Source URL: www.inahta.org Language: English - Date: 2015-03-23 11:47:56 Tax reform Value added tax Biosimilar
107	factsheet \| about EBG patients sustainability Add to Reading List Source URL: www.egagenerics.com Language: English - Date: 2015-05-06 09:02:00 Hospira Pharmacology Biologic Clinical research Pharmaceutical sciences Biosimilar Biotechnology Drugs
108	happy family eating ice cream Add to Reading List Source URL: www.egagenerics.com Language: English - Date: 2015-05-06 11:51:41 Pharmacy Hospira Pharmaceutical industry Pharmaceutical medicine Biosimilar Essential medicines Pharmaceutical sciences Medicine Pharmacology
109	The Science of Extrapolation EBG Biosimilars 2015, London Martina Weise, MD Federal Institute for Drugs and Medical Devices (BfArM), Germany Add to Reading List Source URL: www.egagenerics.com Language: English - Date: 2015-05-08 06:12:04 Biotechnology Drugs Amgen Hospira Pharmacology Growth factors Biologic Extrapolation Filgrastim Medicine Biology Biosimilar
110	Reading List \| Biosimilar Medicinal Products patients sustainability Add to Reading List Source URL: www.egagenerics.com Language: English - Date: 2015-05-06 09:02:05 Medicine Biosimilar Drugs Biologic European Medicines Agency Pharmacovigilance Monoclonal antibodies Biotechnology Pharmaceutical sciences Pharmacology

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