A randomized phase I pharmacokinetic trial comparing the potential biosimilar adalimumab (CinnoRA®) with the reference product (Humira®) in healthy volunteers

Author:

Jamshidi Ahmadreza1ORCID,Sabzvari Araz2,Anjidani Nassim3,Shahpari Ramin3,Badri Nima4

Affiliation:

1. Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran

2. CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran

3. Medical Department, Orchid Pharmed Company, Tehran, Iran

4. Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

Funder

CinnaGen Co.

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference14 articles.

1. SmPC. Humira 40 mg solution for injection in pre-filled syringe: abbVie limited; 2018 [updated 2018 Jun 28; cited 2018]. Available from: https://www.medicines.org.uk/emc/product/2150/smpc

2. Humira full prescribing information: abbVie Inc.; 2017 [updated 12 2017]. Available from: http://www.rxabbvie.com/pdf/humira.pdf

3. World health organization guidelines on evaluation of similar biotherapeutic products (sbps): expert committee on biological standardization Geneva. Switzerland: World Health Organization; 2009 [cited 2017]. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf

4. FDA guidance for industry scientific considerations in demonstrating biosimilarity to a reference product; U.S. Department of health and human services, food and drug administration, center for drug evaluation and research (CDER), center for biologics evaluation and research (CBER). 2015 [cited 2018 Jul 15]. Available from: https://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

5. European medicines agency guideline on similar biological medicinal products 2014 [cited 2017]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf.

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