Switching between reference adalimumab and biosimilars in chronic immune‐mediated inflammatory diseases: A systematic literature review

Author:

García‐Beloso Nerea1ORCID,Altabás‐González Irene23,Samartín‐Ucha Marisol13,Gayoso‐Rey Mónica1,De Castro‐Parga María Luísa4,Salgado‐Barreira Ángel5,Cibeira‐Badia Amelia6,Piñeiro‐Corrales María Guadalupe1,González‐Vilas Daniel7,Pego‐Reigosa Jose María23,Martínez‐López de Castro Noemí13

Affiliation:

1. Department of Pharmacy University Hospital Complex of Vigo Vigo Spain

2. Department of Rheumatology University Hospital Complex of Vigo Vigo Spain

3. IRIDIS (Investigation in Rheumatology and Immune‐Mediated Diseases) Group Galicia Sur Health Research Institute, SERGAS‐UVIGO Vigo Spain

4. Department of Digestive University Hospital Complex of Vigo Vigo Spain

5. Methodology and Statistics Unit Galicia Sur Health Research Institute (IIS Galicia Sur, SERGAS‐UVIGO Vigo Spain

6. Department of Scientific Library University Hospital Complex of Vigo Vigo Spain

7. Department of Dermatology University Hospital Complex of Vigo Vigo Spain

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference54 articles.

1. European Medicines Agency (EMA).Guidelines on similar biological medicinal products. Accessed December 7 2019.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf

2. US Food and Drug Administration.Guidance for Industry: Scientific considerations in demonstrating biosimilarity to a reference product. Rockville MD: US Food and Drug Administration; 2015. Accessed December 28 2020.https://www.fda.gov/media/82647/download

3. Biosimilar switching—current state of knowledge;Wiland P;Reumatologia,2018

4. Biosimilars in the EU: information guide for health professionals.2019. Accessed October 24 2020.https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf

5. Humira® (adalimumab).Information from the EMA. Accessed October 24 2020.https://www.ema.europa.eu/en/medicines/human/EPAR/humira

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