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Literature DB >> 24065599

Different pharmaceutical products need similar terminology.

Daan J A Crommelin¹, Jon S B de Vlieger, Vera Weinstein, Stefan Mühlebach, Vinod P Shah, Huub Schellekens.

Abstract

In the last decade, discussions on the development of the regulatory framework of generic versions of complex drugs such as biologicals and non-biological complex drugs have attracted broad attention. The terminology used is far from harmonized and can lead to multiple interpretations of legal texts, reflection papers, and guidance documents regarding market introduction as well as reimbursement. This article describes the meaning of relevant terms in different global regions (Europe, USA, WHO) and offers a proposal for a globally accepted terminology regarding (non-) biological complex drugs.

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Year: 2013 PMID： 24065599 PMCID： PMC3889525 DOI： 10.1208/s12248-013-9532-0

Source DB: PubMed Journal: AAPS J ISSN： 1550-7416 Impact factor: 4.009

4 in total

1. Biosimilars-why terminology matters.

Authors: Martina Weise; Marie-Christine Bielsky; Karen De Smet; Falk Ehmann; Niklas Ekman; Gopalan Narayanan; Hans-Karl Heim; Esa Heinonen; Kowid Ho; Robin Thorpe; Camille Vleminckx; Meenu Wadhwa; Christian K Schneider
Journal: Nat Biotechnol Date: 2011-08-05 Impact factor: 54.908

2. Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies.

Authors: Gerrit Borchard; Beat Flühmann; Stefan Mühlebach
Journal: Regul Toxicol Pharmacol Date: 2012-08-23 Impact factor: 3.271

Review 3. Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines.

Authors: Falk Ehmann; Kumiko Sakai-Kato; Ruth Duncan; Dolores Hernán Pérez de la Ossa; Ruben Pita; Jean-Marc Vidal; Ashish Kohli; Laszlo Tothfalusi; Alan Sanh; Sandrine Tinton; Jean-Louis Robert; Beatriz Silva Lima; Marisa Papaluca Amati
Journal: Nanomedicine (Lond) Date: 2013-05 Impact factor: 5.307

4. The therapeutic equivalence of complex drugs.

Authors: Huub Schellekens; Ety Klinger; Stefan Mühlebach; Jean-Francois Brin; Gert Storm; Daan J A Crommelin
Journal: Regul Toxicol Pharmacol Date: 2010-10-14 Impact factor: 3.271

4 in total

12 in total

Review 1. Nanomedicines and Nanosimilars: Looking for a New and Dynamic Regulatory "Astrolabe" Inspired System.

Authors: Costas Demetzos; Paraskevi Kavatzikidou; Natassa Pippa; Emmanuel Stratakis
Journal: AAPS PharmSciTech Date: 2020-01-13 Impact factor: 3.246

2. Use of iron sucrose and red blood cell transfusions in anaemic cancer patients in France (OncoFer study).

Authors: Elisabeth Luporsi; Alain Toledano; Dominique Spaeth; Florian Scotté; Marc Espié; Stéphanie Perot; Ladan Duvillié; Isabelle Pithois Merli; Roland Bugat
Journal: Support Care Cancer Date: 2016-12-03 Impact factor: 3.603

3. Knowledge, Attitude, and Practice Towards Biosimilars and Interchangeable Products: A Prescriptive Insight by the Pharmacists.

Authors: Sadia Shakeel; Mohamed Azmi Hassali; Hina Rehman; Anees Ur Rehman; Jaya Muneswarao
Journal: Int J Gen Med Date: 2020-11-11

4. Barriers to the uptake of biosimilars and possible solutions: a Belgian case study.

Authors: Pieter Dylst; Arnold Vulto; Steven Simoens
Journal: Pharmacoeconomics Date: 2014-07 Impact factor: 4.981

Review 5. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider.

Authors: Huub Schellekens; Sven Stegemann; Vera Weinstein; Jon S B de Vlieger; Beat Flühmann; Stefan Mühlebach; Rogério Gaspar; Vinod P Shah; Daan J A Crommelin
Journal: AAPS J Date: 2013-09-25 Impact factor: 4.009

6. Cardiovascular, liver, and renal toxicity associated with an intravenous ferric carboxymaltose similar versus the originator compound.

Authors: Jorge E Toblli; Gabriel Cao; Luis Rico; Margarita Angerosa
Journal: Drug Des Devel Ther Date: 2017-11-30 Impact factor: 4.162

7. Medication practice in hospitals: are nanosimilars evaluated and substituted correctly?

Authors: Josefien Knoeff; Beat Flühmann; Stefan Mühlebach
Journal: Eur J Hosp Pharm Date: 2017-01-23

Review 8. Differences between intravenous iron products: focus on treatment of iron deficiency in chronic heart failure patients.

Authors: Alejandro Martin-Malo; Gerrit Borchard; Beat Flühmann; Claudio Mori; Donald Silverberg; Ewa A Jankowska
Journal: ESC Heart Fail Date: 2019-01-29

9. Diluting ferric carboxymaltose in sodium chloride infusion solution (0.9% w/v) in polypropylene bottles and bags: effects on chemical stability.

Authors: Erik Philipp; Michaela Braitsch; Tobias Bichsel; Stefan Mühlebach
Journal: Eur J Hosp Pharm Date: 2015-08-12

Review 10. A Comprehensive Review on Copemyl^®.

Authors: Pietro Annovazzi; Antonio Bertolotto; Vincenzo Brescia Morra; Claudio Gasperini; Enrico Montanari; Pierluigi Navarra; Francesco Patti; Maria Pia Sormani; Angelo Ghezzi
Journal: Neurol Ther Date: 2017-07-31

Review 3. Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines.

Review 1. Nanomedicines and Nanosimilars: Looking for a New and Dynamic Regulatory "Astrolabe" Inspired System.

Review 5. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider.

Review 8. Differences between intravenous iron products: focus on treatment of iron deficiency in chronic heart failure patients.

Review 10. A Comprehensive Review on Copemyl®.

Review 10. A Comprehensive Review on Copemyl^®.