Population Pharmacokinetics of CMAB008 (an Infliximab Biosimilar) and Remicade® in Healthy Subjects and Patients with Moderately to Severely Active Rheumatoid Arthritis

Author:

Su YinORCID,Li Jing,Wang Chenguang,Zhang Xunmin,Hou Sheng,Guo Huaizu,Deng Chenhui,Ou Lun,Wang Jinwei

Funder

National Key R&D Program of China

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),General Medicine

Reference20 articles.

1. European Medicines Agency (EMA). https://www.ema.europa.eu/en/medicines/human/EPAR/remicade#authorisation-details-section. Accessed 2 Oct 2009.

2. US Food and Drug Administration. Remicade® (infliximab) US prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5138lbl.pdf. Revised May 2006.

3. Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120:5111–7.

4. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs). October 2009. https://www.who.int/publications/m/item/sbp-trs-977-Annex-2

5. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. 2015 April. https://www.fda.gov/regulatory-information/search-fdaguidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product

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