The road to biosimilars in rare diseases ‐ ongoing lessons from Gaucher disease-Reference-Cited by-同舟云学术

The road to biosimilars in rare diseases ‐ ongoing lessons from Gaucher disease

Published:2019-12-23 Issue:3 Volume:95 Page:233-237
ISSN:0361-8609
Container-title:American Journal of Hematology
language:en
Short-container-title:Am J Hematol

Author:

Drelichman Guillermo¹,Castañeda‐Hernández Gilberto²^ORCID,Cem Ar Muhlis³,Dragosky Marta⁴,Garcia Ricardo⁵,Lee Howard⁶,Moiseev Sergey⁷^ORCID,Naderi Majid⁸,Rosenbaum Hanna⁹,Žnidar Irena¹⁰^ORCID,Zuluaga Andrés Felipe¹¹,Freisens Selena¹²,Mistry Pramod K.¹³^ORCID

Affiliation:

1. Hospital de Niños Ricardo Gutiérrez Buenos Aires Argentina

2. Departamento de FarmacologíaCentro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional Mexico City Mexico

3. Division of Hematology, Department of Internal MedicineIstanbul University‐Cerrahpasa, Cerrahpasa Faculty of Medicine Istanbul Turkey

4. Departamento de OncohematologíaHenry Moore Institute Buenos Aires Argentina

5. Centro Latino Americano de Pesquisa em Biológicos São Paulo Brazil

6. Department of Clinical Pharmacology and TherapeuticsSeoul National University College of Medicine and Hospital, Graduate School of Convergence Science and Technology, Seoul National University South Korea

7. Tareev Clinic of Internal DiseasesSechenov First Moscow State Medical University Moscow Russia

8. Genetic Research Center in Non‐Communicable DiseaseZahedan University of Medical Sciences Zahedan Iran

9. Hematology Clinic, Clalit services Nazareth Towers Israel

10. International Gaucher Alliance Dursley UK

11. Departamento de Farmacologia y Toxicologia, Facultad de MedicinaUniversidad de Antioquia Medellín Colombia

12. Global Medical AffairsSanofi Genzyme Cambridge Massachusetts

13. Department of MedicineYale University School of Medicine New Haven Connecticut

Funder

Sanofi Genzyme

Sanofi

Publisher

Wiley

Subject

Hematology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/ajh.25701

Reference10 articles.

1. World Health Organization. Regulatory Expectations and Risk Assessment for Biotherapeutic Products 2014.https://www.who.int/biologicals/WHO_Risk_Assessment_for_Biotherapeutics_1st_PC_24_Jan_2014.pdf. Accessed June 2019.

2. United States Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Guidance for Industry 2015.https://www.fda.gov/media/82647/download. Accessed June 2019.

3. European Medicines Agency Committee for Medicinal Products for Human Use(CHMP).CHMP/437/04 Rev 1. Guideline on similar biological medicinal products 2014.https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf. Accessed June 2019.

4. International Federation of Pharmaceutical Manufacturers & Associations. IFPMA policy statement on non‐comparable biotherapeutic products 2014.https://www.ifpma.org/wp‐content/uploads/2016/02/Non‐comparable_Biotherapeutic_Products__English__02.pdf. Accessed June 2019.

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