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Expert Opinion on Drug Safety Volume 14, 2015 - Issue 3
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Original Research

Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars

Gustavo GramppAmgen, Inc., 4000 Nelson Rd, Longmont, CO 80503, USA+1 303 401 2587; +1 303 401 4404; [email protected]
, PhD,
Machaon BonafedeTruven Health Analytics, Boston, MA, USA
, PhD MPH,
Thomas FelixAmgen, Inc., Washington, DC, USA
, MD,
Edward LiUniversity of New England, College of Pharmacy, Department of Pharmacy Practice, Portland, ME, USA
, PharmD BCOP,
Michael MaleckiAmgen, Inc., Thousand Oaks, CA, USA
, PhD &
J Michael SprafkaAmgen, Inc., Thousand Oaks, CA, USA
, PhD MPH
Pages 349-360 | Published online: 05 Jan 2015

Citations (12)

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Read on this site (2)

Thomas Felix, John B. Jordan, Catherine Akers, Bina Patel & Daniela Drago. (2019) Current state of biologic pharmacovigilance in the European Union: improvements are needed. Expert Opinion on Drug Safety 18:3, pages 231-240.
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G Borchard & D.J.A Crommelin. (2018) Equivalence of glatiramer acetate products: challenges in assessing pharmaceutical equivalence and critical clinical performance attributes. Expert Opinion on Drug Delivery 15:3, pages 247-259.
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Articles from other publishers (10)

A. A. Soldatov, Zh. I. Avdeeva, V. P. Bondarev & V. D. Mosyagin. (2019) Authorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA. BIOpreparations. Prevention, Diagnosis, Treatment 19:1, pages 17-27.
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Thomas Felix, Binakumari Patel, Brian D. Bradbury & Gustavo Grampp. 2018. Biosimilars. Biosimilars 631 652 .
Davide Imberti, Marco Marietta, Hernan Polo Friz & Claudio Cimminiello. (2017) The introduction of biosimilars of low molecular weight heparins in Europe: a critical review and reappraisal endorsed by the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV). Thrombosis Journal 15:1.
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Leonie Hussaarts, Stefan Mühlebach, Vinod P. Shah, Scott McNeil, Gerrit Borchard, Beat Flühmann, Vera Weinstein, Sesha Neervannan, Elwyn Griffiths, Wenlei Jiang, Elena Wolff-Holz, Daan J.A. Crommelin & Jon S.B. de Vlieger. (2017) Equivalence of complex drug products: advances in and challenges for current regulatory frameworks. Annals of the New York Academy of Sciences 1407:1, pages 39-49.
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James G. Stevenson & Larry Green. (2016) Biologics, Pharmacovigilance, and Patient Safety: It’s All in the Name. Journal of Managed Care & Specialty Pharmacy 22:8, pages 927-930.
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Niels S. Vermeer, Hans C. Ebbers, Sabine M. J. M. Straus, Hubert G. M. Leufkens, Toine C. G. Egberts & Marie L. De Bruin. (2016) The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study. Pharmacoepidemiology and Drug Safety 25:3, pages 297-306.
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Gustavo Grampp & Sundar Ramanan. (2015) The Diversity of Biosimilar Design and Development: Implications for Policies and Stakeholders. BioDrugs 29:6, pages 365-372.
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Gustavo Grampp & Thomas Felix. (2015) Pharmacovigilance Considerations for Biosimilars in the USA. BioDrugs 29:5, pages 309-321.
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Stella Stergiopoulos & Kenneth Getz. (2015) Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices. Drug Safety 38:8, pages 687-692.
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Jingdong Chao, Martha Skup, Emily Alexander, Namita Tundia, Dendy Macaulay, Eric Wu & Parvez Mulani. (2015) Nomenclature and Traceability Debate for Biosimilars: Small-Molecule Surrogates Lend Support for Distinguishable Nonproprietary Names. Advances in Therapy 32:3, pages 270-283.
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