The first subsequent entry biologic authorized for market in Canada: The story of Omnitrope, a recombinant human growth hormone
Author:
Publisher
Elsevier BV
Subject
Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology
Reference3 articles.
1. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs),2010
2. Summary basis of decision, Omnitrope,2009
3. Product monograph: Omnitrope, somatropin [rDNA origin] for injection,2009
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1. Safety and effectiveness of Omnitrope® (somatropin) in PATRO Children: a multi-center, post-marketing surveillance study comparison of US and international cohort data;European Journal of Pediatrics;2022-03-11
2. An ever-evolving landscape: an update on the rapidly changing regulation and reimbursement of biosimilars in Canada;Generics and Biosimilars Initiative Journal;2019-09-15
3. Current state of subsequent entry biologics (biosimilars) in Canada: a view from regulatory, reimbursement, clinician, and patient perspectives;Generics and Biosimilars Initiative Journal;2016-09-15
4. Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges;Generics and Biosimilars Initiative Journal;2015-03-15
5. Developing Clinical Trials for Biosimilars;Seminars in Oncology;2014-02
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